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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-01406 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000659064 | |||
| 09-117 | |||
| 09-117 | Other Identifier | Memorial Sloan-Kettering Cancer Center | |
| 8147 | Other Identifier | CTEP | |
| P30CA008748 | U.S. NIH Grant/Contract | View source | |
| U01CA069856 | U.S. NIH Grant/Contract | View source |
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This phase I/II trial is studying the side effects of giving cixutumumab together with temsirolimus and to see how well it works in treating patients with metastatic prostate cancer. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cixutumumab together with temsirolimus may kill more tumor cells.
PRIMARY OBJECTIVES:
I. To confirm the safety and tolerability of IMC-A12 (cixutumumab) and temsirolimus using the recommended phase II dose level for advanced solid tumors in chemo-naive patients with metastatic castration-resistant prostate cancer and a rising prostate-specific antigen (PSA). (Phase I) II. To confirm the safety and tolerability of IMC-A12 and temsirolimus given on an every three weeks dosing schedule. (Phase I Extension) II. To determine the tumor response rate and/or composite time to progression (cTTP) for chemotherapy-naive patients with castration-resistant prostate cancer (CRPC) receiving the combination of IMC-A12 and CCI-779 (temsirolimus). (Phase II)
SECONDARY OBJECTIVES:
I. To determine the maximal percent decrease in PSA from baseline. II. To determine the change in PSA doubling time (PSADT). III. To determine the time to PSA progression and 6-month progression-free survival (PFS).
IV. To determine the rate of adverse events.
EXPLORATORY OBJECTIVES:
I. To evaluate changes in circulating tumor cell (CTC) numbers with time. II. To evaluate IGF1R and androgen receptor (AR) in CTCs and correlate with response.
III. To evaluate profiling CTCs at the molecular level by polymerase chain reaction (PCR) for prostate cancer-specific genes.
IV. To explore the association between clinical outcomes, administration of therapy, and serial fludeoxyglucose F 18 (FDG)-positron emission tomography (PET) imaging.
V. To correlate fluorine F 18 FMDHT (18-FDHT)-PET imaging findings with outcome measures of response.
VI. To perform tumor biopsies and evaluate biomarkers that may correlate with active feedback and tumor response to therapy, including anti-insulin receptor substrate 1 (IRS-1), anti-IRS-2, phosphorylated (p) protein kinase B (Akt)(S473), p-ribosomal protein S6 kinase (70/S6K), anti-phospho-AKT1 substrate 1 (proline-rich) (PRAS 40), and phosphatase and tensin homolog gene (PTEN) status.
OUTLINE: This is a multicenter study.
Patients receive cixutumumab intravenously (IV) over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (cixutumumab, temsirolimus) | Experimental | Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cixutumumab | Biological | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| cTTP | Defined as the time from the first day of treatment to the earliest one of the following: tumor progression by RECIST; unequivocal evidence of progression by bone scan (at least two new lesions with confirmation at subsequent imaging); new skeletal events; symptomatic progression; or other clinical events attributable to prostate cancer that necessitate major interventions. This Outcome Measure is related to the Phase II portion of the Trial, which did not occur. Therefore, there is no data to report. | Up to 4 weeks after completion of study treatment |
| Tumor Response Rate | Defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) and/or the proportion of patients who achieve a greater than 50% reduction in serum PSA compared to baseline. | Up to 4 weeks after completion of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PSA Doubling Time | Compared using descriptive statistics. PSA doubling time is defined as the number of months it would take for PSA to increase two-fold. PSADT is inversely proportional to the slope of the regression line for the relation between log PSA and time. If this slope is negative, so the patient's PSA is going down over time, then the PSADT is negative. | Week 1, Week 5, Week 9, Week 13, Week 17, Week 21 and Week 25 |
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Inclusion Criteria:
Histologically or cytologically confirmed adenocarcinoma of the prostate
Evidence of progressive disease during androgen-deprivation therapy (including a trial of antiandrogen-withdrawal therapy), as defined by ≥ 1 of the following criteria:
Castrate levels of serum testosterone (i.e., ≤ 50 ng/dL)
No known brain metastases
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 OR Karnofsky PS 70-100%
Life expectancy > 6 months
Leukocytes ≥ 3,000/μL
Absolute neutrophil count (ANC) ≥ 1,500/μL
Platelet count ≥ 100,000/μL
Hemoglobin ≥ 9 g/dL
Total bilirubin ≤ 2 times upper limit of normal (ULN)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN
Serum creatinine ≤ 1.5 times ULN
Creatinine clearance ≥ 50 mL/min
Able to adhere to the study visit schedule and other study requirements
Fertile patients must use effective contraception before, during, and for 3 months after completion of study treatment
Adequate lung function (pulmonary function test ≥ 70% for diffusion capacity of the lung for carbon monoxide [DLco])
No poorly controlled diabetes mellitus
No other malignancy within the past 3 years except for treated basal cell or squamous cell carcinoma of the skin or superficial transitional cell carcinoma of the bladder
No uncontrolled major illness including, but not limited to, any of the following:
No other concurrent anticancer agents or treatments
No prior chemotherapy, except for neoadjuvant chemotherapy
No prior anti-insulin-like growth factor receptor (IGFR) agents or mammalian target of rapamycin (mTOR) inhibitors
No prior strontium-89, rhenium-186, rhenium-188, or samarium-153 radionucleotide therapy
Prior standard-dose radiotherapy to the pelvis for prostate cancer and/or additional external-beam radiotherapy to metastatic sites allowed
More than 4 weeks since prior surgery, radiotherapy, combined androgen blockade (excluding single-agent gonadotropin releasing-hormone agonists/antagonists), or investigational therapies
No concurrent second-line hormonal agents, including ketoconazole, diethylstilbestrol, other estrogen-like agents, or finasteride
No concurrent corticosteroids unless patient is on a stable maintenance dose of hydrocortisone (≤ 30 mg/day) for ≥ 3 months
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| Name | Affiliation | Role |
|---|---|---|
| Dana Rathkopf | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | United States | ||
| University of Michigan Comprehensive Cancer Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | IMC-A12: 6 mg/kg & Temsirolimus (CCI-779): 20 mg | Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cixutumumab: Given IV Diagnostic Laboratory Biomarker Analysis: Correlative studies Temsirolimus: Given IV Arm -1 (Cycle=28 days, IMC-A12: 6 mg/kg IV over 60 min weekly, Temsirolimus (CCI-779): 20 mg IV over 30 min weekly) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Diagnostic Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Temsirolimus | Drug | Given IV |
|
|
| Duration of Effect | Summarized using descriptive statistics. | From the time of first dose until the time of progression, assessed up to 4 weeks after completion of study treatment |
| Maximal Percentage Change in Serum PSA as Compared to Week 12 Versus Baseline | Summarized using descriptive statistics (eg, mean, standard deviation, median, minimum, maximum). Maximum percent change in serum PSA (i.e., 100%*[(value at Week 12 minus value at baseline)/value at baseline]) | From baseline to week 12 |
| Progression-free Survival | Summarized using descriptive statistics. Median PFS over time will be determined using Kaplan Meier method. This Outcome Measure was related to the Phase 2 portion of the study, which did not occur. Therefore, there is no data to report. | From the time of first dose until objective tumor progression or death, assessed up to 4 weeks after completion of study treatment |
| Rate of Adverse Events According to NCI CTCAE Version 4.0 | Adverse event summaries will be organized by body system, frequency of occurrence, intensity (ie, severity grade), and causality or attribution. Please see Adverse Event/Serious Adverse Event Section. | Up to 4 weeks after completion of study treatment |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
| FG001 | IMC-A12: 6 mg/kg & Temsirolimus (CCI-779): 25 mg | Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cixutumumab: Given IV Diagnostic Laboratory Biomarker Analysis: Correlative studies Temsirolimus: Given IV Cycle=28 days, IMC-A12: 6 mg/kg IV over 60 min weekly, Temsirolimus (CCI-779): 25 mg IV over 30 min weekly |
| FG002 | IMC-A12: 20 mg/kg & Temsirolimus (CCI-779): 20 mg | Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cixutumumab: Given IV Diagnostic Laboratory Biomarker Analysis: Correlative studies Temsirolimus: Given IV Cycle=21 days:IMC-A12: 20 mg/kg IV over 90 min on day 1 Temsirolimus (CCI-779): 20 mg IV over 30 min on day 1 Fluorine-18 2-Fluoro-2-deoxy-D-Glucose (18F-FDG): 10 mCi IVB at baseline, within 1 week of the 1st txt, 12 weeks, 24 weeks, and end of study |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | IMC-A12: 6mg/kg Temsirolimus 20 mg | Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cixutumumab: Given IV Diagnostic Laboratory Biomarker Analysis: Correlative studies Temsirolimus: Given IV Arm -1 (Cycle=28 days, IMC-A12: 6 mg/kg IV over 60 min weekly, Temsirolimus (CCI-779): 20 mg IV over 30 min weekly) |
| BG001 | IMC-A12: 6 mg/kg Temsirolimus 25 mg | Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cixutumumab: Given IV Diagnostic Laboratory Biomarker Analysis: Correlative studies Temsirolimus: Given IV Cycle=28 days, IMC-A12: 6 mg/kg IV over 60 min weekly, Temsirolimus (CCI-779): 25 mg IV over 30 min weekly |
| BG002 | IMC-A12: 20 mg/kg Temsirolimus 20 mg | Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cixutumumab: Given IV Diagnostic Laboratory Biomarker Analysis: Correlative studies Temsirolimus: Given IV Cycle=21 days:IMC-A12: 20 mg/kg IV over 90 min on day 1 Temsirolimus (CCI-779): 20 mg IV over 30 min on day 1 Fluorine-18 2-Fluoro-2-deoxy-D-Glucose (18F-FDG): 10 mCi IVB at baseline, within 1 week of the 1st txt, 12 weeks, 24 weeks, and end of study |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | No |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Number | 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 | cTTP | Defined as the time from the first day of treatment to the earliest one of the following: tumor progression by RECIST; unequivocal evidence of progression by bone scan (at least two new lesions with confirmation at subsequent imaging); new skeletal events; symptomatic progression; or other clinical events attributable to prostate cancer that necessitate major interventions. This Outcome Measure is related to the Phase II portion of the Trial, which did not occur. Therefore, there is no data to report. | All patients had withdrawn from study prior to data analysis. This Outcome Measure is related to the Phase II portion of the Trial, which did not occur. Therefore, there is no data to report. | Posted | Up to 4 weeks after completion of study treatment |
|
| |||||||||||||||||||||||||
| Primary | Tumor Response Rate | Defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) and/or the proportion of patients who achieve a greater than 50% reduction in serum PSA compared to baseline. | Posted | Count of Participants | Participants | Up to 4 weeks after completion of study treatment |
| |||||||||||||||||||||||||
| Secondary | Change in PSA Doubling Time | Compared using descriptive statistics. PSA doubling time is defined as the number of months it would take for PSA to increase two-fold. PSADT is inversely proportional to the slope of the regression line for the relation between log PSA and time. If this slope is negative, so the patient's PSA is going down over time, then the PSADT is negative. | Outcome not calculated. PSA decline from baseline and imaging response (at twelve weeks) instead which are recognized PCWG3 endpoints for metastatic castration resistant disease was the outcome. | Posted | Week 1, Week 5, Week 9, Week 13, Week 17, Week 21 and Week 25 |
| ||||||||||||||||||||||||||
| Secondary | Duration of Effect | Summarized using descriptive statistics. | Posted | Median | 95% Confidence Interval | weeks | From the time of first dose until the time of progression, assessed up to 4 weeks after completion of study treatment |
| ||||||||||||||||||||||||
| Secondary | Maximal Percentage Change in Serum PSA as Compared to Week 12 Versus Baseline | Summarized using descriptive statistics (eg, mean, standard deviation, median, minimum, maximum). Maximum percent change in serum PSA (i.e., 100%*[(value at Week 12 minus value at baseline)/value at baseline]) | Posted | Median | 95% Confidence Interval | percentage change in Serum PSA | From baseline to week 12 |
| ||||||||||||||||||||||||
| Secondary | Progression-free Survival | Summarized using descriptive statistics. Median PFS over time will be determined using Kaplan Meier method. This Outcome Measure was related to the Phase 2 portion of the study, which did not occur. Therefore, there is no data to report. | All patients had withdrawn from study prior to data analysis. | Posted | From the time of first dose until objective tumor progression or death, assessed up to 4 weeks after completion of study treatment |
| ||||||||||||||||||||||||||
| Secondary | Rate of Adverse Events According to NCI CTCAE Version 4.0 | Adverse event summaries will be organized by body system, frequency of occurrence, intensity (ie, severity grade), and causality or attribution. Please see Adverse Event/Serious Adverse Event Section. | Posted | Number | percentage of participants affected | Up to 4 weeks after completion of study treatment |
|
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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 | IMC-A12: 6mg/kg Temsirolimus 20 mg | Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cixutumumab: Given IV Diagnostic Laboratory Biomarker Analysis: Correlative studies Temsirolimus: Given IV Arm -1 (Cycle=28 days, IMC-A12: 6 mg/kg IV over 60 min weekly, Temsirolimus (CCI-779): 20 mg IV over 30 min weekly) | 3 | 6 | 6 | 6 | ||
| EG001 | IMC-A12: 6 mg/kg Temsirolimus 25 mg | Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cixutumumab: Given IV Diagnostic Laboratory Biomarker Analysis: Correlative studies Temsirolimus: Given IV Cycle=28 days, IMC-A12: 6 mg/kg IV over 60 min weekly, Temsirolimus (CCI-779): 25 mg IV over 30 min weekly | 1 | 5 | 5 | 5 | ||
| EG002 | IMC-A12: 20 mg/kg Temsirolimus 20 mg | Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cixutumumab: Given IV Diagnostic Laboratory Biomarker Analysis: Correlative studies Temsirolimus: Given IV Cycle=21 days:IMC-A12: 20 mg/kg IV over 90 min on day 1 Temsirolimus (CCI-779): 20 mg IV over 30 min on day 1 Fluorine-18 2-Fluoro-2-deoxy-D-Glucose (18F-FDG): 10 mCi IVB at baseline, within 1 week of the 1st txt, 12 weeks, 24 weeks, and end of study | 1 | 5 | 3 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lipase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Serum amylase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Optic nerve disorder | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Cholesterol high | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Peripheral motor neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Psychiatric disorders - Other, specify | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Rectal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Renal and urinary disorders - Other, specify | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Serum amylase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Skin infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Tooth infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
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| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
cTTP This Outcome Measure is related to the Phase II portion of the Trial, which did not occur. All patients had withdrawn from study prior to data analysis. Therefore, there is no data to report for this measure.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dana Rathkopf | Memorial Sloan Kettering Cancer Center | 646-422-4379 | rathkopd@mskcc.org |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C557414 | cixutumumab |
| C401859 | temsirolimus |
| D020123 | Sirolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cixutumumab: Given IV
Diagnostic Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV Cycle=21 days:IMC-A12: 20 mg/kg IV over 90 min on day 1 Temsirolimus (CCI-779): 20 mg IV over 30 min on day 1 Fluorine-18 2-Fluoro-2-deoxy-D-Glucose (18F-FDG): 10 mCi IVB at baseline, within 1 week of the 1st txt, 12 weeks, 24 weeks, and end of study
|
|
| OG002 | IMC-A12: 20 mg/kg Temsirolimus 20 mg | Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cixutumumab: Given IV Diagnostic Laboratory Biomarker Analysis: Correlative studies Temsirolimus: Given IV Cycle=21 days:IMC-A12: 20 mg/kg IV over 90 min on day 1 Temsirolimus (CCI-779): 20 mg IV over 30 min on day 1 Fluorine-18 2-Fluoro-2-deoxy-D-Glucose (18F-FDG): 10 mCi IVB at baseline, within 1 week of the 1st txt, 12 weeks, 24 weeks, and end of study |
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|
|
Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cixutumumab: Given IV Diagnostic Laboratory Biomarker Analysis: Correlative studies Temsirolimus: Given IV Cycle=21 days:IMC-A12: 20 mg/kg IV over 90 min on day 1 Temsirolimus (CCI-779): 20 mg IV over 30 min on day 1 Fluorine-18 2-Fluoro-2-deoxy-D-Glucose (18F-FDG): 10 mCi IVB at baseline, within 1 week of the 1st txt, 12 weeks, 24 weeks, and end of study |
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| OG002 | Arm 1A | Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cixutumumab: Given IV Diagnostic Laboratory Biomarker Analysis: Correlative studies Temsirolimus: Given IV Cycle=21 days:IMC-A12: 20 mg/kg IV over 90 min on day 1 Temsirolimus (CCI-779): 20 mg IV over 30 min on day 1 Fluorine-18 2-Fluoro-2-deoxy-D-Glucose (18F-FDG): 10 mCi IVB at baseline, within 1 week of the 1st txt, 12 weeks, 24 weeks, and end of study |
|
Patients receive cixutumumab IV over 60-70 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cixutumumab: Given IV Diagnostic Laboratory Biomarker Analysis: Correlative studies Temsirolimus: Given IV Cycle=21 days:IMC-A12: 20 mg/kg IV over 90 min on day 1 Temsirolimus (CCI-779): 20 mg IV over 30 min on day 1 Fluorine-18 2-Fluoro-2-deoxy-D-Glucose (18F-FDG): 10 mCi IVB at baseline, within 1 week of the 1st txt, 12 weeks, 24 weeks, and end of study |
|
|