Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P30CA068485 | U.S. NIH Grant/Contract | View source | |
| VU-VICC-THO-0746 |
Not provided
Not provided
Not provided
Ph I completed. Funding became unavailable causing Ph II to cease after two patients were enrolled.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) may make tumor cells more sensitive to radiation therapy. Giving nab-paclitaxel together with radiation therapy and carboplatin may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of giving nab-paclitaxel together with carboplatin and radiation therapy and to see how well it works in treating patients with stage III non-small-cell lung cancer that cannot be removed by surgery.
OBJECTIVES:
Primary
Secondary
To assess safety and tolerability and identify dose-limiting toxicities in patients receiving nab-paclitaxel combined concurrently with carboplatin and radiotherapy. (Phase I)
To assess progression-free survival, response rates, and survival. (Phase I)
To assess overall survival and response rates in all patients treated on this study. (Phase II)
To assess the safety and tolerability of patients receiving nab-paclitaxel combined concurrently with carboplatin and radiotherapy followed by two courses of nab-paclitaxel/carboplatin as consolidation. (Phase II) OUTLINE: This is a multicenter study.
Phase I:
Phase II: Patients receive concurrent chemoradiotherapy at the Maximum Tolerated Dose (MTD) of nab-paclitaxel followed by consolidation chemotherapy as in phase I.
After completion of study treatment, patients are followed at 2 months, every 3 months for 2 years, every 4 months for 2 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 98 patients (15 patients for phase I and 83 patients for phase II) will be accrued for this study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | nab-paclitaxel+ carboplatin + radiation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | (AUC 2) through a vein over 30 minutes following nab-paclitaxel, once per week x 7 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose of Nab-paclitaxel When Combined Concurrently With Carboplatin and Radiation (Phase I) | The highest dose in milligrams per meter of body surface squared (mg/m2) of nab-paclitaxel in combination with carboplatin while maintaining tolerability. Cohorts of 3-6 patients received escalating doses of nab-paclitaxel in combination with carboplatin until the maximum tolerated dose (MTD) was achieved. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity (DLT) during the initial cycle of therapy. DLTs per Common Toxicity Criteria v 3.0: recurring non-hematological (except esophagitis) > Grade 2, non-hematological or esophagitis > Grade 3 toxicities that are symptomatically unacceptable to patient and result in treatment delay for > 2 weeks, persistent toxicity resulting in treatment delay for > 2 weeks. | 7 weeks |
| Progression-free Survival (Phase II) | Estimated probable duration of life without disease progression, from on-study date to earlier of progression date, or date of death from any cause, using the Kaplan-Meier method with censoring (see Analysis Population Description for additional details). Disease progression is defined by Response Evaluation in Solid Tumors (RECIST) v.1.1: >= 20% increase in sum of the longest diameter of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions | On-study to lesser of date of progression or date of death from any cause (assessed up to 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (Phase I) | Estimated probable duration of life without disease progression, from on-study date to earlier of progression date, or date of death from any cause, using the Kaplan-Meier method with censoring (see Analysis Population Description for additional details). Disease progression is defined by Response Evaluation in Solid Tumors (RECIST) v.1.1: >= 20% increase in sum of the longest diameter of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions |
| Measure | Description | Time Frame |
|---|---|---|
| Secreted Protein Acidic and Rich in Cysteine (SPARC) Gene Expression | Secreted protein acidic and rich in cysteine (SPARC) gene expression in tumor specimens. | On receipt of tumor tissue blocks |
Inclusion Criteria for Phase I and Phase II Patients:
Patients must voluntarily sign and date an informed consent before the initiation of any study procedures
Patients must have non-metastatic, inoperable, Stage IIIA or IIIB histologically or cytologically documented NSCLC without evidence of malignant pleural effusion
Patients must not have received any prior systemic chemotherapy, thoracic radiotherapy or surgical resection for treatment of NSCLC
Patients must have at least one site of unidirectionally measurable disease as defined by Response Evaluation in Solid Tumors (RECIST) criteria
Patients must be ≥ 3 weeks from a formal exploratory thoracotomy
Patients must have a Radiation Oncology and Medical Oncology consult and approval prior to study entry
Patients must be ≥ 18 years of age
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Women of childbearing potential must have a negative baseline serum pregnancy or a negative urine pregnancy test within 7 days prior to Week 1, Day 1 and must not be breast feeding.
Women of childbearing potential and men with a sexual partner of child bearing potential must use an effective method of contraception beginning prior to study entry, for the duration of the study participation and for a minimum of 3 months after the last dose of chemotherapy.
Patients must have adequate hepatic, renal, lung and bone marrow function as defined below:
Exclusion Criteria for Phase I and Phase II Patients:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vicki Keedy, MD | Vanderbilt-Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Purchase Cancer Group - Paducah | Paducah | Kentucky | 42002 | United States | ||
| Oregon Health Sciences University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25845992 | Derived | Lammers PE, Lu B, Horn L, Shyr Y, Keedy V. nab-Paclitaxel in Combination With Weekly Carboplatin With Concurrent Radiotherapy in Stage III Non-Small Cell Lung Cancer. Oncologist. 2015 May;20(5):491-2. doi: 10.1634/theoncologist.2015-0030. Epub 2015 Apr 6. |
Not provided
Not provided
Twenty-two patients signed consent on this study, nine of which were ineligible to receive treatment.
Patients were recruited from November 2007 through September 2011
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Phase I | Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 weekly for 7 weeks with concurrent radiotherapy |
| FG001 | Phase II | MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| nab-paclitaxel | Drug | Phase I: beginning at 40 mg/m2 through a vein over 30 minutes once per week x 7 weeks Phase II: Maximum tolerated dose through a vein over 30 minutes once per week x 7 weeks |
|
|
| Radiation therapy | Radiation | 3D conformal radiotherapy or Intensity-Modulated Radiation Therapy (IMRT), 2.0 Gy per day x 5 days per week for 33 days during Weeks 1-7 ; Total Dose = 66 Gy |
|
| On-study to lesser of date of progression or date of death from any cause (assessed up to 2 years) |
| Overall Survival (Phase I) | Estimated probable duration of life from on-study date to date of death from any cause, using Kaplan-Meier method with censoring (see Analysis Population Description for additional details). | On-study date to date of death from any cause (assessed up to 2 years) |
| Response (Phase I) | Number of patients in each response category, per Response Evaluation in Solid Tumors (RECIST) v.1.1: complete response (CR), disappearance of target lesions; partial response (PR) >=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or PR. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD. | On-treatment date to date of progressive disease (assessed up to 2 years) |
| Number of Patients With Each Worst Grade Toxicity (Phase I) | Count of patients according to the worst-grade toxicity (WGT) experienced by each, where worst-grade toxicity is per NCI common toxicity criteria: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening; Grade 5, death. | On-study date to 30 days following final dose of study drug |
| Overall Survival (Phase II) | Estimated probable duration of life from on-study date to date of death from any cause, using Kaplan-Meier method with censoring (see Analysis Population Description for additional details. Too few patients were enrolled in the Phase II arm for an analysis of overall survival | Time Frame: date on study to date of death from any cause or last known date alive |
| Number of Patients With Each Worst Grade Toxicity (Phase II) | The number of patients with worst-grade toxicity at each of five grades following NCI Common Toxicity Criteria: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, disabling, 5 = death | at 16 weeks |
| Response (Phase II) | Number of patients in each response category, per Response Evaluation in Solid Tumors (RECIST) v.1.1: complete response (CR), disappearance of target lesions; partial response (PR) >=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or PR. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD. | On-treatment date to date of progressive disease (assessed up to 2 years) |
| Portland |
| Oregon |
| 97201 |
| United States |
| Erlanger Cancer Center at Erlanger Hospital - Baroness | Chattanooga | Tennessee | 37403 | United States |
| Vanderbilt-Ingram Cancer Center - Cool Springs | Nashville | Tennessee | 37064 | United States |
| Vanderbilt-Ingram Cancer Center at Franklin | Nashville | Tennessee | 37064 | United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232-6838 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Consented patients
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase I | Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 weekly for 7 weeks with concurrent radiotherapy |
| BG001 | Phase II | MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy. |
| BG002 | 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 |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Maximum Tolerated Dose of Nab-paclitaxel When Combined Concurrently With Carboplatin and Radiation (Phase I) | The highest dose in milligrams per meter of body surface squared (mg/m2) of nab-paclitaxel in combination with carboplatin while maintaining tolerability. Cohorts of 3-6 patients received escalating doses of nab-paclitaxel in combination with carboplatin until the maximum tolerated dose (MTD) was achieved. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity (DLT) during the initial cycle of therapy. DLTs per Common Toxicity Criteria v 3.0: recurring non-hematological (except esophagitis) > Grade 2, non-hematological or esophagitis > Grade 3 toxicities that are symptomatically unacceptable to patient and result in treatment delay for > 2 weeks, persistent toxicity resulting in treatment delay for > 2 weeks. | MTD based on clinical performance of those patients who received the study drug. One patient withdrew before receiving treatment. No formal statistical analysis, such as hypothesis testing, was performed. | Posted | Number | mg/m2 | 7 weeks |
|
|
| ||||||||||||||||||||||||||
| Primary | Progression-free Survival (Phase II) | Estimated probable duration of life without disease progression, from on-study date to earlier of progression date, or date of death from any cause, using the Kaplan-Meier method with censoring (see Analysis Population Description for additional details). Disease progression is defined by Response Evaluation in Solid Tumors (RECIST) v.1.1: >= 20% increase in sum of the longest diameter of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions | All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where either death or progression is an event, with censoring for non-progressed, non-expired patients at greater of off-study date or last known date alive. | Posted | Median | 95% Confidence Interval | days | On-study to lesser of date of progression or date of death from any cause (assessed up to 2 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Progression-free Survival (Phase I) | Estimated probable duration of life without disease progression, from on-study date to earlier of progression date, or date of death from any cause, using the Kaplan-Meier method with censoring (see Analysis Population Description for additional details). Disease progression is defined by Response Evaluation in Solid Tumors (RECIST) v.1.1: >= 20% increase in sum of the longest diameter of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions | All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where either death or progression is an event, with censoring for non-progressed, non-expired patients at greater of off-study date or last known date alive. | Posted | Median | 95% Confidence Interval | days | On-study to lesser of date of progression or date of death from any cause (assessed up to 2 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival (Phase I) | Estimated probable duration of life from on-study date to date of death from any cause, using Kaplan-Meier method with censoring (see Analysis Population Description for additional details). | All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where death is an event, with censoring for non-expired patients at greater of off-study date or last known alive date. | Posted | Median | 95% Confidence Interval | days | On-study date to date of death from any cause (assessed up to 2 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Response (Phase I) | Number of patients in each response category, per Response Evaluation in Solid Tumors (RECIST) v.1.1: complete response (CR), disappearance of target lesions; partial response (PR) >=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or PR. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD. | All patients with best overall response data; patients are excluded if best overall response data is missing (0) or if the patient is non-evaluable for best overall response (n = 1) | Posted | Number | participants | On-treatment date to date of progressive disease (assessed up to 2 years) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Patients With Each Worst Grade Toxicity (Phase I) | Count of patients according to the worst-grade toxicity (WGT) experienced by each, where worst-grade toxicity is per NCI common toxicity criteria: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening; Grade 5, death. | Total number of patients reported with any toxicity. One patient did not experience toxicity. | Posted | Number | participants | On-study date to 30 days following final dose of study drug |
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival (Phase II) | Estimated probable duration of life from on-study date to date of death from any cause, using Kaplan-Meier method with censoring (see Analysis Population Description for additional details. Too few patients were enrolled in the Phase II arm for an analysis of overall survival | Too few patients were enrolled in the Phase II arm for an analysis of overall survival | Posted | Time Frame: date on study to date of death from any cause or last known date alive |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Patients With Each Worst Grade Toxicity (Phase II) | The number of patients with worst-grade toxicity at each of five grades following NCI Common Toxicity Criteria: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, disabling, 5 = death | Treated patients who experienced a toxicity. | Posted | Number | participants | at 16 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Response (Phase II) | Number of patients in each response category, per Response Evaluation in Solid Tumors (RECIST) v.1.1: complete response (CR), disappearance of target lesions; partial response (PR) >=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or PR. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD. | All patients with best overall response data; patients are excluded if best overall response data is missing (n = 0) or if the patient is non-evaluable for best overall response (n = 1) | Posted | Number | participants | On-treatment date to date of progressive disease (assessed up to 2 years) |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Secreted Protein Acidic and Rich in Cysteine (SPARC) Gene Expression | Secreted protein acidic and rich in cysteine (SPARC) gene expression in tumor specimens. | Investigators elected not to perform this analysis. | Posted | On receipt of tumor tissue blocks |
|
|
This study began November 2007 through September 2011. Data were collected through April 2013.
One patient withdrew before receiving treatment
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase I | Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy. | 5 | 10 | 10 | 10 | ||
| EG001 | Phase II | MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy. | 1 | 2 | 2 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) |
| ||
| neutrophils | Blood and lymphatic system disorders | CTCAE (3.0) |
| ||
| platelets | Blood and lymphatic system disorders | CTCAE (3.0) |
| ||
| radiation dermatitis | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
| ||
| hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| thrombosis | Vascular disorders | CTCAE (3.0) |
| ||
| febrile neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) |
| ||
| digoxin toxicity | Cardiac disorders | CTCAE (3.0) |
| ||
| sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| fever in the absence of neutropenia (defined as ANC < 1.0 x 10e9/L) | General disorders | CTCAE (3.0) |
| ||
| hypotension | Cardiac disorders | CTCAE (3.0) |
| ||
| hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| International Ratio of prothrombin time | Blood and lymphatic system disorders | CTCAE (3.0) |
| ||
| speech impairment | Nervous system disorders | CTCAE (3.0) |
| ||
| atrial fibrillation | Cardiac disorders | CTCAE (3.0) |
| ||
| sinus tachycardia, probably related to pneumonia | Cardiac disorders | CTCAE (3.0) |
| ||
| pain-chest, thorax NOS | General disorders | CTCAE (3.0) |
| ||
| dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| tachypnea, probably related to pneumonia | Cardiac disorders | CTCAE (3.0) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) |
| ||
| leukocytes (total WBC) | Blood and lymphatic system disorders | CTCAE (3.0) |
| ||
| neutrophils/granulocytes (ANC/ANG) | Blood and lymphatic system disorders | CTCAE (3.0) |
| ||
| platelets | Blood and lymphatic system disorders | CTCAE (3.0) |
| ||
| blood/bone marrow-other | Blood and lymphatic system disorders | CTCAE (3.0) |
| ||
| nausea | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| dehydration | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| diarrhea | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| anorexia | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| vomiting | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| constipation | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| esophagitis | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| mucositis/stomatitis (functional/symptomatic)-esophagus | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| dysphagia | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| flatulence | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| heartburn/dyspepsia | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| mucositits/stomatitis (functional/symptomatic) oral cavity | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| taste alteration | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| fatigue | General disorders | CTCAE (3.0) |
| ||
| constitutional symptoms-other | General disorders | CTCAE (3.0) |
| ||
| insomnia | Psychiatric disorders | CTCAE (3.0) |
| ||
| fever in the absence of neutropenia, where neutropenia is defined as ANC < 1.0 x 10e9/L | General disorders | CTCAE (3.0) |
| ||
| sweating | General disorders | CTCAE (3.0) |
| ||
| hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| metabolic/laboratory-other | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| hypophosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| AST, SGOT (serum glutamic oxaloacetic transaminase | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| alkaline phosphatase | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| hyperbilirubinemia | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| creatinine | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| hypermagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| pain-chest wall | Musculoskeletal and connective tissue disorders | CTCAE (3.0) |
| ||
| pain-back | Musculoskeletal and connective tissue disorders | CTCAE (3.0) |
| ||
| pain-head/headache | Nervous system disorders | CTCAE (3.0) |
| ||
| pain-throat, larynx | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| pain-chest, thorax | Musculoskeletal and connective tissue disorders | CTCAE (3.0) |
| ||
| pain-extremity, limb | Musculoskeletal and connective tissue disorders | CTCAE (3.0) |
| ||
| pain-joint | Musculoskeletal and connective tissue disorders | CTCAE (3.0) |
| ||
| burn | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
| ||
| dermatology, skin-other | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
| ||
| dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
| ||
| rash-dermatitis, radiation | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
| ||
| alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
| ||
| pruritis | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
| ||
| rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
| ||
| rash-acne/acneiform | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
| ||
| cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| pneumonia/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| febrile neutropenia (ANC < 1.0 x 10e9/L, fever >= 38.5 degrees Celsius | Infections and infestations | CTCAE (3.0) |
| ||
| infection-upper airway with Grade 3 or 4 neutrophils, ANC < 1.0 x 10e9/L | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| infection-other | Infections and infestations | CTCAE (3.0) |
| ||
| infection-bladder, normal ANC or Grade 1 or 2 neutrophils | Renal and urinary disorders | CTCAE (3.0) |
| ||
| infection-sinus, normal ANC or Grade 1 or 2 neutrophils | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| infection-stomach, with normal ANC or Grade 1 or 2 neutrophils | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| dizziness | Nervous system disorders | CTCAE (3.0) |
| ||
| anxiety | Psychiatric disorders | CTCAE (3.0) |
| ||
| neurology-other | Nervous system disorders | CTCAE (3.0) |
| ||
| tremor | Nervous system disorders | CTCAE (3.0) |
| ||
| hypotension | Cardiac disorders | CTCAE (3.0) |
| ||
| cardiac general-other | Cardiac disorders | CTCAE (3.0) |
| ||
| hot flashes/flushes | Endocrine disorders | CTCAE (3.0) |
| ||
| hemorrhage-nose | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| edema-limb | Blood and lymphatic system disorders | CTCAE (3.0) |
| ||
| erectile dysfunction | Reproductive system and breast disorders | CTCAE (3.0) |
| ||
| gastrointestinal other | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| hypercalcemia | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| pain-bone | Musculoskeletal and connective tissue disorders | CTCAE (3.0) |
| ||
| pain-cardiac | Cardiac disorders | CTCAE (3.0) |
| ||
| Infection with normal ANC or grade 1 or 2 neutrophils | Infections and infestations | CTCAE (3.0) |
| ||
| Infection with unknown ANC-pneumonia | Infections and infestations | CTCAE (3.0) |
|
This Phase I/II study progressed into Phase II, but terminated shortly thereafter due to lack of funding.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vicki Keedy, MD | Vanderbilt-Ingram Cancer Center | 615-936-3524 | vicki.keedy@vanderbilt.edu |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D016190 | Carboplatin |
| C520255 | 130-nm albumin-bound paclitaxel |
| D013660 | Taxes |
| D000068196 | Albumin-Bound Paclitaxel |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013812 | Therapeutics |
Not provided
Not provided
| >=65 years |
|
| Male |
|
|
|
|
|
|
|
|
|
|