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Safety of patients
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| Name | Class |
|---|---|
| CTI BioPharma | INDUSTRY |
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This study is intended to evaluate the role of paclitaxel poliglumex and carboplatin in the treatment of unresectable Stage III non-small cell lung cancer along with radiation therapy in a multi-institutional trial. Consolidation chemotherapy with paclitaxel poliglumex and carboplatin will follow the completion of chemoradiation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (first 12 eligible patients) | Other | Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. |
|
| Cohort 2 (remaining patients) | Experimental | Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel poliglumex | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) Rate |
| 6 months |
| Overall Survival (OS) | OS = time from patient registration to death of all causes | Completion of follow-up (follow-up ranged from 3 months to 6 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Failure-free Survival (FFS) Rate |
| 6 months |
| Failure-free Survival (FFS) |
Not provided
Inclusion Criteria:
Histologically or cytologically documented NSCLC, including squamous cell carcinoma, adenocarcinoma (including bronchoalveolar cell), and large cell anaplastic carcinoma (including giant and clear cell carcinomas).
Eligible Disease Stages: Inoperable IIIA and Selected IIIB
Local radiation oncologist must approve patient eligibility prior to entry on study.
Patients must have measurable disease.
Prior Therapy:
ECOG performance status 0-1
Required Initial Laboratory Values (must be submitted within 16 days prior to registration):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ramaswamy Govindan, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States | ||
| Washington Hospital Center |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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Enrollment to the study was opened on 04/05/2006 and enrollment to the study closed 06/30/2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 (First 12 Eligible Patients) | Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Carboplatin | Drug |
|
|
| External beam radiation therapy | Radiation |
|
The time between patient registration and a failure event (progression, relapse, or death of all cause, whichever is first)
| Completion of follow-up (follow-up ranged from 3 months to 6 years) |
| Response Rates | Overall best response using RECIST 1.0 | 4 years |
| Incidence and Severity of Radiation-induced Esophagitis | 30 days following completion of treatment (approximately 114 days) |
| Incidence and Severity of Radiation-induced Pneumonitis | 30 days following completion of treatment (approximately 114 days) |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Rush University Medical College | Chicago | Illinois | United States |
| University of Kansas | Lawrence | Kansas | 66045 | United States |
| University of Minnesota, Twin Cities | Minneapolis | Minnesota | United States |
| University of Missouri, Columbia | Columbia | Missouri | 65211 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| FG001 | Cohort 2 (Remaining Patients) | Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 (First 12 Eligible Patients) | Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. |
| BG001 | Cohort 2 (Remaining Patients) | Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. |
| 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, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Gender | 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 | Overall Survival (OS) Rate |
| Participants with unknown expiration dates were censored at the date of last clinical contact. | Posted | Number | percentage of participants | 6 months |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Failure-free Survival (FFS) Rate |
| Participants with unknown event dates were censored at the date of last clinical contact. | Posted | Number | percentage of participants | 6 months |
| |||||||||||||||||||||||||||||||
| Secondary | Failure-free Survival (FFS) | The time between patient registration and a failure event (progression, relapse, or death of all cause, whichever is first) | Participants with unknown event dates were censored at the date of last clinical contact. | Posted | Median | 95% Confidence Interval | months | Completion of follow-up (follow-up ranged from 3 months to 6 years) |
| ||||||||||||||||||||||||||||||
| Secondary | Response Rates | Overall best response using RECIST 1.0 | Posted | Number | participants | 4 years |
| ||||||||||||||||||||||||||||||||
| Secondary | Incidence and Severity of Radiation-induced Esophagitis | Using CTCAE Version 3.0 | Posted | Number | participants | 30 days following completion of treatment (approximately 114 days) |
| ||||||||||||||||||||||||||||||||
| Primary | Overall Survival (OS) | OS = time from patient registration to death of all causes | Participants with unknown expiration dates were censored at the date of last clinical contact. | Posted | Median | 95% Confidence Interval | months | Completion of follow-up (follow-up ranged from 3 months to 6 years) |
| ||||||||||||||||||||||||||||||
| Secondary | Incidence and Severity of Radiation-induced Pneumonitis | Using CTCAE Version 3.0. | Posted | Number | participants | 30 days following completion of treatment (approximately 114 days) |
|
Adverse events were collected from the start of treatment through 30 days after completion of treatment (approximately 114 days)
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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 | Cohort 1 (First 12 Eligible Patients) | Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. | 5 | 8 | 8 | 8 | ||
| EG001 | Cohort 2 (Remaining Patients) | Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Death NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Febrile neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Leukocytes (WBC) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Myoglobin | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophils | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| PTT | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Radiation pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Respiratory failure (death) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Troponin | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AST | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline phosphatase | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Blurred vison | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Chills | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspepsia/heartburn | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Elevated troponin | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Febrile neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Fever - no infection | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Flashing lights/floaters | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage - gastritis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hiccoughs | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with grade 0-2 neutrophils | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Leukocytes (WBC) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Mood alteration - anxiety | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
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| Mood alteration - depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Neutrophils | Investigations | CTCAE (3.0) | Systematic Assessment |
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| Pain: other | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Palpitations | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Phantom pain | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Platelets | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Radiation pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Puritis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Radiation dermatitis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Syncope | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Upper respiratory infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Voice changes/dysarthria | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (3.0) | Systematic Assessment |
|
(3) grade 5 serious adverse events occurred and led to the study closing early for the safety of participants.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ramaswamy Govindan, M.D. | Washington University School of Medicine | 314-362-5737 | rgovinda@dom.wustl.edu |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C509139 | paclitaxel poliglumex |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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