| ID | Type | Description | Link |
|---|---|---|---|
| 04-C-0257 |
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This is a Phase II study of docetaxel, bevacizumab, prednisone and thalidomide in patients with androgen independent metastatic prostate cancer who are previously untreated with chemotherapy. The primary objective of this study is to determine if the combination of docetaxel, thalidomide and bevacizumab is able to be associated with a sufficiently high proportion of patients with a prostate-specific antigen (PSA) response to be worthy of further investigation in metastatic prostate cancer. We will also be looking at multiple secondary endpoints. These will include possible pharmacokinetic interactions among the study agents, potential correlation between patient genotype and efficacy of treatment. We will also be looking for circulating tumor cells in blood before and after treatment. Additionally we will be monitoring the tolerability of the regimen and survival duration as endpoints as well. We hope to use this trial to build on the promising results seen in our thalidomide/docetaxel protocol where there was a significant PSA decline and a trend toward survival benefit.
This is a Phase II study of docetaxel, bevacizumab, prednisone and thalidomide in patients with androgen independent metastatic prostate cancer who are previously untreated with chemotherapy. The primary objective of this study is to determine if the combination of docetaxel, thalidomide and bevacizumab is able to be associated with a sufficiently high proportion of patients with a PSA response to be worthy of further investigation in metastatic prostate cancer. We will also be looking at multiple secondary endpoints. These will include possible pharmacokinetic interactions among the study agents, potential correlation between patient genotype and efficacy of treatment. We will also be looking for circulating endothelial cells in blood before and after treatment. Additionally we will be monitoring the tolerability of the regimen, time to disease progression, and survival duration as endpoints as well. We hope to use this trial to build on the promising results seen in our thalidomide/docetaxel protocol where there was a significant PSA decline and a trend toward survival benefit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main cohort - Prostate Cancer | Experimental | Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days. |
|
| Expansion cohort - Prostate Cancer | Experimental | Docetaxel 75 mg/m^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had a Prostate-specific Antigen (PSA) Response | PSA response was assessed by the PSA Consensus Criteria. PSA decline is defined as a decline in PSA of at least 50% with no other evidence of disease progression. | 21.6 months |
| Immune Response | Cellular immune response and cytokines were evaluated after two cycles of therapy in the expansion cohort. Those cycles included treatment with bevacizumab and docetaxel as a pre-medication. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module. | 37 months |
| Time to Progression Using Bubley Criteria |
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Androgen-independent metastatic adenocarcinoma of the prostate defined as progressive metastatic disease while on gonadotropin releasing hormone (GnRH) agonists or post surgical castration
Histopathological documentation of prostate cancer confirmed in the National Cancer Institute (NCI) Laboratory of Pathology at the National Institutes of Health, the Pathology Department at Walter Reed Medical Center or the Pathology Department at National Naval Medical Center, prior to starting this study. In addition, patients whose slides are lost or unavailable will be eligible for the study if they provide documentation of prostate cancer and if they meet criteria of clinically progressive prostate cancer as outlined in section 3.1.1.3.
Clinically progressive prostate cancer documented prior to entry. Progression must be documented by at least one of the following parameters:
Patients must have undergone bilateral surgical castration or must continue on GNRH agonist.
Those patients receiving an anti-androgen agent and are entering the trial due to a rise in PSA must demonstrate a continued rise in PSA 4 weeks after stopping flutamide and 6 weeks after stopping bicalutamide or nilutamide.
Patients may not have received any chemotherapy for metastatic prostate cancer
Age greater than or equal to 18 years
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Life expectancy of greater than 3 months
Patients must have adequate organ and marrow function as defined below:
Leukocytes- greater than or equal to 3,000/microliter
Absolute neutrophil count- greater than or equal to 1,500/microliter
Platelets- greater than or equal to 100,000/microliter
Hemoglobin- greater than or equal to 8.0g/L - transfusions acceptable
Total bilirubin- less than or equal to 1.5 times the institutional upper limits of normal
Aspartate aminotransferase (AST)serum glutamic oxaloacetic transaminase(SGOT) and alanine aminotransferase (ALT)serum glutamic pyruvic transaminase(SGPT) - less than or equal to 2.5 times the institutional upper limits of normal
Creatinine or Creatinine clearance- less than or equal to 1.5 times the institutional upper limits of normal or greater than or equal to 40 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal.
Recovered from any toxicity from surgery or radiotherapy
Must be willing to travel from their home to the National Institutes of Health (NIH) for follow-up visits
Able and willing to follow instructions and conform to protocol.
Patients may have had no other active malignancy within the past 2 years with the exception of non-melanoma skin cancer and superficial bladder carcinoma
No history of myocardial infarction within the past 6 months, uncontrolled congestive heart failure (CHF) or uncontrolled angina pectoris
Patients must agree to use adequate contraception (abstinence; hormonal or barrier method of birth control) for the study and at least 2 months after completion.
Ability to understand and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
Present clinical signs or symptoms of brain and/or leptomeningeal metastases confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) brain scan.
Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (American Heart Association (AHA) Class II or worse), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Persistent systolic blood pressure greater than or equal to 170 mmHg or diastolic blood pressure greater than or equal to 100 mmHg.
Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with docetaxel, bevacizumab, and/or the combination.
Proteinuria, as demonstrated by a urine, protein, creatinine (UPC) ratio greater than or equal to 1.0 at screening, required to be assessed if urine dipstick is greater than or equal to 1+.
Urine protein should be screened by urine analysis for Urine Protein Creatinine (UPC) ratio. For UPC ratio > 0.5, 24-hour urine protein should be obtained and the level should be < 1000 mg for patient enrollment. Note: UPC ratio of spot urine is an estimation of the 24 urine protein excretion - a UPC ratio of 1 is roughly equivalent to a 24-hour urine protein of 1 gm. UPC ratio is calculated using one of the following formula:
Therapeutic anticoagulation with coumadin, heparins, or heparinoids.
Greater than Grade 2 peripheral neuropathy at baseline.
History of transient ischemic attacks (TIA) or cerebrovascular accident (CVA) within the past 2 years.
History of allergic reaction to docetaxel, prednisone, thalidomide and/or bevacizumab or related products.
Patients who are on concurrent investigational agent(s)
Patients who are unable to ingest oral medication.
INCLUSION OF WOMEN AND MINORITIES
Men of all races and ethnic groups are eligible for this trial. Every effort will be made to recruit minorities in this study. Women are ineligible for this study.
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| Name | Affiliation | Role |
|---|---|---|
| Ravi Madan, M.D. | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7865431 | Background | Horwitz SB. Taxol (paclitaxel): mechanisms of action. Ann Oncol. 1994;5 Suppl 6:S3-6. | |
| 1458483 | Background | McDonnell TJ, Troncoso P, Brisbay SM, Logothetis C, Chung LW, Hsieh JT, Tu SM, Campbell ML. Expression of the protooncogene bcl-2 in the prostate and its association with emergence of androgen-independent prostate cancer. Cancer Res. 1992 Dec 15;52(24):6940-4. |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Main Cohort - Prostate Cancer | Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 7, 2017 |
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| Thalidomide | Drug | Thalidomide 200 mg by mouth daily throughout the cycle. |
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| Prednisone | Drug | Prednisone 10 mg by mouth daily throughout the cycle. |
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| bevacizumab | Biological | Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days. |
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| polymorphism analysis | Genetic | Two buffy coat tubes (two 7mL blue tiger top tubes) will be obtained and wrapped in foil when the patient enters onto the study. DNA (deoxyribonucleic acid) will be isolated only for the purpose of genotype analysis of enzymes with putative relevance for docetaxel or thalidomide disposition. |
|
| immunoenzyme technique | Other | The PBMC (peripheral blood mononuclear cells) of patients will be analyzed pre-treatment and post cycle 2 for any changes in the function of regulatory T cells. The following analysis will be performed: flow cytometry analysis, CD4 CD25 T cell enrichment, and immunosuppression assay. |
|
| laboratory biomarker analysis | Other | Serum and urine samples will be collected at baseline and monthly to measure VEGF (vascular endothelial growth factor) levels. |
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| pharmacological study | Other | Plasma concentrations of docetaxel and thalidomide will be determined to assess interactions between docetaxel (and thalidomide) and the concomitant therapy.The analysis will be performed using a validated method based on liquid chromotography with mass-spectrometric detection. |
|
Time to disease progression was based on the Prostate-Specific Antigen (PSA) Working Group 1 Criteria (Bubley Criteria) and standard Response Evaluation Criteria in Solid Tumors (RECIST) for measurable disease. Per the criteria, investigators report at a minimum a PSA decline of at least 50% and this must be confirmed by a second PSA value 4 or more weeks later. Patients may not demonstrate clinical or radiographic evidence of disease progression during this time period.
| up to 40 months |
| Disease Progression by Clinical and Radiographic Criteria Without the Use of Prostate-Specific Antigen (PSA) | Clinical and radiographic response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking s reference the smallest sum LD since the treatment started. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded or the appearance of one or more new lesions. | up to 34 months |
| Number of Participants Who Died After a Follow Up of 34 Months Following Treatment | From on study date to date of death at 34 months. | 34 months |
| Plasma Concentrations of Docetaxel and Thalidomide and Clinical Activity or Toxicity | The analysis will be performed using a validated method based on liquid chromatography with mass-spectrometric detection. | Pre-dose on C1D1, 5 minutes before the end of infusion, and 15, and 30 minutes, and 1, 2,4,8, and 24 hours after the end of infusion |
| Number of Participants With a Significant Increase in Circulating Apoptotic Endothelial Cell (CAEC) Level | The assay utilized has no standard curve. Categorizing patients with ≥ 75% PSA decline in one group and < PSA decline in another group, every patient is their own control with comparison of CAEC at baseline vs. 6 weeks (after two cycles of treatment). Blood is drawn from the patient and a million viable mononuclear cells are counted and then it is determined how many CAECs are in the specimen. The cell count is then compared from baseline to post 2 cycles of treatment. Thus, "significant increase" is dependent upon this comparison and varies between patients. | Baseline and at 6 weeks (after two cycles of treatment) |
| Analyze the Patients Genotype With Regard to Cytochrome P450 2C19 Polymorphism and Correlate That With Pharmacokinetics and Efficacy | Single nucleotide polymorphisms in genes that play an important role in eliminations pathways for docetaxel (in the CYP3A4 and CYP3A5 genes) and thalidomide (CYP2C19) will be evaluated. | Patient entry onto the study |
| Usefulness of Dynamic Magnetic Resonance Imaging (MRI) to Monitor the Progression of Bony and Soft Tissue Disease in Metastatic Prostate Cancer | Target lesions in the bone or soft tissues will be identified from the participant computed tomography (CT) scan. Dynamic MRI will be performed after the intravenous administration of 0.1 mmol/kg of Gadolinium chelate. Progression is defined by the RECIST criteria and is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment starts or the appearance of new lesions. | Baseline and at 3 month intervals until progression |
| Changes in the Molecular Markers of Angiogenesis (Including, But Not Limited to Serum and Urine Vascular Endothelial Growth Factor (VEGF)) Before and After Administration of Docetaxel, Prednisone, Thalidomide and Bevacizumab | Baseline and monthly |
| 7850782 | Background | Berchem GJ, Bosseler M, Sugars LY, Voeller HJ, Zeitlin S, Gelmann EP. Androgens induce resistance to bcl-2-mediated apoptosis in LNCaP prostate cancer cells. Cancer Res. 1995 Feb 15;55(4):735-8. |
| Expansion Cohort - Prostate Cancer |
Docetaxel 75 mg/m^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Main Cohort - Prostate Cancer | Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days. |
| BG001 | Expansion Cohort - Prostate Cancer | Docetaxel 75 mg/m^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Had a Prostate-specific Antigen (PSA) Response | PSA response was assessed by the PSA Consensus Criteria. PSA decline is defined as a decline in PSA of at least 50% with no other evidence of disease progression. | The main cohort was designed to evaluate clinical progression and the expansion cohort was designed to evaluate immune response. Thus the expansion cohort is not included here. | Posted | Count of Participants | Participants | 21.6 months |
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| Primary | Immune Response | Cellular immune response and cytokines were evaluated after two cycles of therapy in the expansion cohort. Those cycles included treatment with bevacizumab and docetaxel as a pre-medication. | Cellular immune response and cytokines were not analyzed as the study outcomes were concentrated on the dual-anti-angiogenesis inhibition properties of the regimen and not immunomodulatory changes. | Posted | 6 weeks |
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| Secondary | Number of Participants With Adverse Events | Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module. | Posted | Count of Participants | Participants | 37 months |
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| Secondary | Time to Progression Using Bubley Criteria | Time to disease progression was based on the Prostate-Specific Antigen (PSA) Working Group 1 Criteria (Bubley Criteria) and standard Response Evaluation Criteria in Solid Tumors (RECIST) for measurable disease. Per the criteria, investigators report at a minimum a PSA decline of at least 50% and this must be confirmed by a second PSA value 4 or more weeks later. Patients may not demonstrate clinical or radiographic evidence of disease progression during this time period. | Per protocol, time to progression using Bubley Criteria was not assessed for the expansion cohort. | Posted | Median | 95% Confidence Interval | Months | up to 40 months |
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| Secondary | Disease Progression by Clinical and Radiographic Criteria Without the Use of Prostate-Specific Antigen (PSA) | Clinical and radiographic response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking s reference the smallest sum LD since the treatment started. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded or the appearance of one or more new lesions. | Only 33/60 participants had measurable disease and were evaluable for this outcome measure. Per protocol, disease progression by clinical and radiographic criteria without the use of PSA was not assessed for the expansion cohort. | Posted | Count of Participants | Participants | up to 34 months |
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| Secondary | Number of Participants Who Died After a Follow Up of 34 Months Following Treatment | From on study date to date of death at 34 months. | Per protocol, this outcome was not assessed for the expansion cohort. | Posted | Count of Participants | Participants | 34 months |
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| Secondary | Plasma Concentrations of Docetaxel and Thalidomide and Clinical Activity or Toxicity | The analysis will be performed using a validated method based on liquid chromatography with mass-spectrometric detection. | The outcome was not assessed as the analysis of plasma bevacizumab concentrations was the main pharmacokinetic secondary outcome in the study. The plasma levels of docetaxel and thalidomide (without bevacizumab) had minimal significance in this study. Analysis of plasma concentrations of docetaxel and thalidomide will not be done. | Posted | Pre-dose on C1D1, 5 minutes before the end of infusion, and 15, and 30 minutes, and 1, 2,4,8, and 24 hours after the end of infusion |
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| Secondary | Number of Participants With a Significant Increase in Circulating Apoptotic Endothelial Cell (CAEC) Level | The assay utilized has no standard curve. Categorizing patients with ≥ 75% PSA decline in one group and < PSA decline in another group, every patient is their own control with comparison of CAEC at baseline vs. 6 weeks (after two cycles of treatment). Blood is drawn from the patient and a million viable mononuclear cells are counted and then it is determined how many CAECs are in the specimen. The cell count is then compared from baseline to post 2 cycles of treatment. Thus, "significant increase" is dependent upon this comparison and varies between patients. | Only 17/60 participants were evaluable for this outcome. Per protocol CAECs were not assessed in the expansion cohort. | Posted | Count of Participants | Participants | Baseline and at 6 weeks (after two cycles of treatment) |
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| Secondary | Analyze the Patients Genotype With Regard to Cytochrome P450 2C19 Polymorphism and Correlate That With Pharmacokinetics and Efficacy | Single nucleotide polymorphisms in genes that play an important role in eliminations pathways for docetaxel (in the CYP3A4 and CYP3A5 genes) and thalidomide (CYP2C19) will be evaluated. | The outcome was not assessed as the clinical significance of cytochrome P450 2C19 polymorphism in angiogenesis is undetermined. This analysis will not be pursued. | Posted | Patient entry onto the study |
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| Secondary | Usefulness of Dynamic Magnetic Resonance Imaging (MRI) to Monitor the Progression of Bony and Soft Tissue Disease in Metastatic Prostate Cancer | Target lesions in the bone or soft tissues will be identified from the participant computed tomography (CT) scan. Dynamic MRI will be performed after the intravenous administration of 0.1 mmol/kg of Gadolinium chelate. Progression is defined by the RECIST criteria and is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment starts or the appearance of new lesions. | The outcome was not assessed as the functionality of dynamic MRI in prostate cancer was poor at the time of this study. Earlier prostate MRI techniques suffered from poor sensitivity and specificity for monitoring progression. | Posted | Baseline and at 3 month intervals until progression |
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| Secondary | Changes in the Molecular Markers of Angiogenesis (Including, But Not Limited to Serum and Urine Vascular Endothelial Growth Factor (VEGF)) Before and After Administration of Docetaxel, Prednisone, Thalidomide and Bevacizumab | The outcome was not assessed. In the study, assessment of circulating apoptotic endothelial cells was the main outcome evaluated for assessing the treatment's antiangiogenic activity. Changes in the molecular markers of angiogenesis will not be pursued. | Posted | Baseline and monthly |
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37 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Main Cohort - Prostate Cancer | Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days. | 35 | 60 | 48 | 60 | 60 | 60 |
| EG001 | Expansion Cohort - Prostate Cancer | Docetaxel 75 mg/m^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added | 1 | 13 | 4 | 13 | 13 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| CNS cerebrovascular ischemia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| CPK (creatine phosphokinase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cardiac arrhythmia - Other, Specify, new onset of A. fib | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cardiac general - Other, Specify, aortic dissection | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Death not associated with CTCAE term::Death NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Death not associated with CTCAE term: Death Progression NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Febrile neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L), fever >=38.5 degrees C) |
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| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GI: Abdomen NOS | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GI: Colon | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GI::Rectum | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GI: Upper GI NOS | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, pulmonary/upper respiratory::Nose | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) : urinary tract NOS |
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| Infection with normal ANC or Grade 1 or 2 neutrophils:Abdomen NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Anal/perianal | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Infection with normal ANC or Grade 1 or 2 neutrophils::Bladder (urinary) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Bronchus | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Catheter-related | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Colon | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with unknown ANC: Urinary tract NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle weakness, generalized or specific area (not due to neuropathy)::Whole body/generalized | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neurology-Other (somnolence | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AG) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain: Back | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Cardiac/heart | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Potassium, serum-high (hyperkalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Proteinuria | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Supraventricular and nodal arrhythmia::Atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Supraventricular and nodal arrhythmia::Nodal/Junctional | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Syncope (fainting) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vessel injury-artery: Aorta | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Wound complication, non-infectious | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection (documented clinically or microbiologically) | Infections and infestations | CTCAE (3.0) | Systematic Assessment | with grade 3 or 4 neutrophils) (ANC <1.0X10e9/L)Skin:cellulitis |
|
| Infection (documented clinically or microbiologically) with Grade 3 or 4 | Infections and infestations | CTCAE (3.0) | Systematic Assessment | neutrophils (ANC1.0x10e9/L) : urinary tract NOS |
|
| Ascites (non-malignant) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with unknown ANC: Wound | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Renal/Genitourinary - Other (acute kidney injury; chronic kidney disease) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Uric acid, serum-high (hyperuricemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cardiac ischemia/infarction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection - Other (sepsis) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Death not associated with CTCAE term: Death, Progression NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline phosphatase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ataxia (incoordination) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bladder spasms | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Blood/Bone marrow - Other (Specify) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Anemia; neutropenia |
|
| Bruising (in absence of Grade 3 or 4 thrombocytopenia) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Burn | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| CPK (creatine phosphokinase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Calcium, serum-high (hypercalcemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cardiac arrhythmia - Other, Specify, | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | bradycardia; cardiac; tachycardia; vasovagal episode |
|
| Cardiac general - Other, Specify, | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | chest discomfort or no CP; diastolic murmur; tachycardia; chest tightness |
|
| Chelitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Coagulation - Other (Specify) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Bleeding at injection site |
|
| Cognitive disturbance | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constitutional Symptoms-Other (Specify,_____) | General disorders | CTCAE (3.0) | Systematic Assessment | night sweats; weight loss |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cytokine release syndrome/acute infusion reaction | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| DIC (disseminated intravascular coagulation) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dental: periodontal disease | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dental: teeth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dermal change lymphedema, phlebolymphedema | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry eye syndrome | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dysphagia (difficulty swallowing) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema: limb | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Febrile Neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (fever of unknown origin without clinically or microbiologically documented infection) (ANC < 1.0 x 10e9/L, fever >=38.5 degrees C) |
|
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment | (in the absence of neutropenia, where neutropenia is defined as AGC<1.0x10e9/L) |
|
| Flu-like symptoms | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Flushing | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| GGT (gamma-Glutamyl transpeptidase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gastritis (including bile reflux gastritis) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gastrointestinal-Other (Specify) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | anorexia; early satiety; GI-disturbance-related to dairy; gingivitis-infection; L abdominal mass; melena; mucositis; stomach cramps secondary to constipation; abdominal bloating; teeth changes color |
|
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Glucose, serum-low (hypoglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gynecomastia | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hair loss/alopecia (scalp or body) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hearing: patients with/without baseline auidgram and not enrolled in a monitoring program) | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Heartburn/dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobinuria | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GI: Abdomen NOS | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GI::Rectum | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GU: Bladder | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GU: Urethra | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GU: Urinary NOS | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, pulmonary/upper respiratory: Nose | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, pulmonary/upper respiratory: Respiratory tract NOS | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hot flashes/flushes | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypopigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Incontinence, anal | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Incontinence, urinary | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0x10e9/L): Abdomen NOS |
|
| Infection - Other, Specify | Infections and infestations | CTCAE (3.0) | Systematic Assessment | bronchitis; left great toe infection; left eye conjunctiva; paronychia R great toe; URI-cough & wheezing; URI-sore throat; upper respiratory infection |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils: Anal/perianal | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils: Blood | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils: Conjuctiva | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils:Larynx | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils:Lung (pneumonia) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils:Middle ear (otitis media) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils:Muscle (infection myositis) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils:Nerve-peripheral | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils:Nose | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils:Oral cavity-gums (gingivitis) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils:paranasal | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils:Sinus | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils:Skin (cellulitis) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils:Ungual (nails) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils:Upper airway NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils:Urinary tract NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with unknown ANC::Middle ear (otitis media) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with unknown ANC::Oral cavity-gums (gingivitis) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with unknown ANC:Sinus | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with unknown ANC::Skin (cellulitis) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with unknown ANC::Soft tissue NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with unknown ANC::Ungual (nails) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with unknown ANC::Upper airway NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with unknown ANC::Urinary tract NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Injection site reaction/extravasation changes | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lipase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Keratitis (corneal inflammatory/corneal ulceration) | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Liver dysfunction/failure (clinical) | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphatics - Other (Specify) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | small upper lobe nodes |
|
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Magnesium, serum-high (hypermagnesemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Magnesium, serum-low (hypomagnesemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Metabolic/Laboratory - Other (Specify) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | LDH, high |
|
| Mood alteration-agitation | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mood alteration::Anxiety | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mood alteration::Depression | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam)::Oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/stomatitis (functional/symptomatic)::Espophagus | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/stomatitis (functional/symptomatic)::Oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle weakness, generalized or specific area (not due to neuropathy)::Extremity-lower | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle weakness, generalized or specific area (not due to neuropathy)::Left-sided | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle weakness, generalized or specific area (not due to neuropathy)::trunk | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle weakness, generalized or specific area (not due to neuropathy)::Whole body/generalized | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Musculoskeletal/Soft tissue - Other (Specify,) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Myositis (inflammation/damage of muscle) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nail changes | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nasal cavity/paranasal sinus reactions | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neurology-Other (Specify,______) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy - cranial::CN IX Motor-pharynx; sensory-ear, pharynx tongue | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy - cranial::CN V Motor-jaw muscles; sensory-facial | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy - cranial::CN VIII Hearing and balance | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy: motor | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy: sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ocular/Visual-Other (Specify,___) | Eye disorders | CTCAE (3.0) | Systematic Assessment | conjunctival injection; decreased visual acuity; diplopia; eye tearing; mucus discharge for eyes; near vision problem |
|
| Ophthalmoplegia/diplopia (double vision) | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Opportunistic infection associated with >=Grade 2 Lymphopenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Osteonecrosis (avascular necrosis) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| PTT (Partial Thromboplastin Time) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain-Other (Specify,R leg pain; shoulder pain; tooth pain; jaw) | General disorders | CTCAE (3.0) | Systematic Assessment | (R) hip/leg pain; finger tips; heel pain; jaw w/hx of ONJ; L calf; L lower jaw sensitivity; left knee; left shoulder pain; lower back pain; pain-(L) elbow and groin; pain-(L) shoulder; R ear pain; R arm pain-mid arm (known bone mets); R hip pain |
|
| Pain: Abdomen NOS | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain: Back | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Cardiac/heart | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Chest wall | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Chest/thorax NOS | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Extremity-limb | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain: Face | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Head/headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Joint | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Muscle | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Oral gums | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Pain NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Pelvis | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Rectum | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Throat/pharynx/larynx | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Perforation, GI::Colon | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pericardial effusion (non-malignant) | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Phlebitis (including superficial thrombosis) | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Phosphate, serum-low (hypophosphatemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Potassium, serum-high (hyperkalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Proteinuria | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other (Specify, ) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash: hand-foot skin reaction | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal/Genitourinary-Other (Specify) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment | hematuria; nephrotic syndrome |
|
| Salivary gland changes/saliva | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Scleral necrosis/meli | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Skin breakdown/decubitus ulcer | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Speech impairment (e.g., dysphasia or aphasia) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Supraventricular and nodal arrhythmia::Atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Supraventricular and nodal arrhythmia::Sinus bradycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sweating (diaphoresis) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Syncope (fainting) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Taste alteration (dysgeusia) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thyroid function, low (hypothyroidism) | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ulcer, GI: Rectum | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ulceration | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Uric acid, serum-high (hyperuricemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary frequency/urgency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary retention (including neurogenic bladder) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vasovagal episode | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vessel injury-vein: Extremity-lower | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vessel injury-vein: Other NOS | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vision-blurred vision | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vision-flashing lights/floaters | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Watery eye (epiphora, tearing) | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Weight gain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Wound complication, non-infectious | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Weight loss | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dermatology/Skin-Other (Specify,_____) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment | cellulitis; ecchymosis; lip-abscess; oral leukopenia; RLE sunburn; rash; decubitus ulcer R buttock; ecchymosis at injection sites; fingers blister; folliculitis; generalized erythema; peeling in sole |
|
| Hemoglobin | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage/Bleeding - other (Specify) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | conjunctiva hemorrhage/right eye; ecchymosis; epistaxis; hematochezia; intermittent hard stool with blood-hematochezia; bleeding to Lovenox sites; bleeding to lower lip |
|
| Muscle weakness, generalized or specific area (not due to neuropathy)::Extremity-upper | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Bone | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Extremity-lower (gait/walking) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sodium, serum-high (hypernatremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection (documented clinically or microbiologically): dental tooth | Infections and infestations | CTCAE (3.0) | Systematic Assessment | with grade 3 or 4 neutrophils (ANC,1.0x10e9/L) |
|
| Infection (documented clinically or microbiologically): upper airway NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment | with grade 3 or 4 neutrophils (ANC<1.0x10e9/L) |
|
| Infection (documented clinically or microbiologically): urinary tract NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment | with grade 3 or 4 neutrophils (ANC<1.0x10e9/L) |
|
| Infection (documented clinically or microbiologically): cellulitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment | with grade 3 or 4 neutrophils (ANC<1.0x10e9/L) |
|
| Obstruction, GU: Ureter | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Obstruction, GU: Urethra | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ravi Madan, M.D. | National Cancer Institute, National Institutes of Health | 301-480-7168 | rm480i@nih.gov |
| Dec 27, 2017 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D013792 | Thalidomide |
| D011241 | Prednisone |
| D000068258 | Bevacizumab |
| D054458 | Amplified Fragment Length Polymorphism Analysis |
| D007124 | Immunoenzyme Techniques |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D016172 | DNA Fingerprinting |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D016133 | Polymerase Chain Reaction |
| D021141 | Nucleic Acid Amplification Techniques |
| D007118 | Immunoassay |
| D007158 | Immunologic Techniques |
| D007150 | Immunohistochemistry |
| D015336 | Molecular Probe Techniques |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|