Polyglutamate Paclitaxel Compared With Docetaxel in Treating Patients With Progressive Non-Small Cell Lung Cancer
Lung Cancer

About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IV non-small cell lung cancer, stage IIIB non-small cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed non-small cell lung cancer (NSCLC) Documented clinical or radiologic disease progression on or after initial systemic therapy Must have received 1 prior platinum-based systemic therapy for NSCLC Measurable or nonmeasurable disease No evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology Brain metastases allowed provided patient received prior standard antitumor therapy for CNS metastases (e.g., whole brain radiotherapy, stereotactic radioablation, or surgery) and the following conditions are met: No prior systemic chemotherapy as a radiosensitizer combined with radiotherapy Obtained stable neurologic function at least 2 weeks before study entry Off steroid therapy or on a tapering regimen Recovered from prior therapy PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Al least 16 weeks Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN AST or ALT no greater than 1.5 times ULN Renal Creatinine no greater than 1.5 times ULN Cardiovascular No unstable angina No myocardial infarction within the past 6 months No evidence of cardiac conduction abnormalities (e.g., bundle branch block or heart block) unless cardiac status stable for the past 6 months Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No evidence of unstable neurological symptoms in the past 4 weeks (2 weeks for neurological symptoms due to brain metastases) No intolerance to excipients of polyglutamate paclitaxel (e.g., poly-L-glutamic acid, poloxamer 188, dibasic sodium phosphate, or monobasic sodium hydroxide) No other unstable medical conditions No clinically significant active infection No neuropathy greater than grade 1 No other concurrent primary malignancy except carcinoma in situ or nonmelanoma skin cancer No circumstance that would preclude study completion or follow-up PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics No prior polyglutamate paclitaxel No prior docetaxel Endocrine therapy See Disease Characteristics Radiotherapy See Disease Characteristics No concurrent radiotherapy Surgery See Disease Characteristics Recovered from prior major surgery Other Recovered from prior therapy More than 2 weeks since prior treatment for NSCLC More than 4 weeks since prior investigational drugs No other concurrent investigational drugs No other concurrent systemic antitumor therapy No concurrent amifostine Concurrent bisphosphonates allowed
Sites / Locations
- Clinical Research Consultants, Incorporated
- Arizona Clinical Research Center
- Highlands Oncology Group - Springdale
- Pacific Cancer Medical Center, Incorporated
- Synergy Hematology/Oncology Medical Associates
- California Cancer Care, Inc.
- California Hematology/Oncology Medical Group
- Northwest Oncology and Hematology Associates
- Florida Oncology Associates
- Hematology Oncology Associates of theTreasure Coast - Port St. Lucie
- Suburban Hematology-Oncology
- Gross Point Medical Center
- Western Kentucky Hematology/Oncology Group
- Kentucky Cancer Clinic
- Saint Joseph Oncology, Incorporated
- Montana Cancer Specialists
- Las Vegas Cancer Center
- Morristown Memorial Hospital
- New Mexico Oncology-Hematology Consultants, Limited
- Queens Medical Associates, PC
- Piedmont Oncology Specialist, II, PLLC
- Odyssey Research Services
- Gabrail Cancer Center - Canton Office
- Ireland Cancer Center
- Pennsylvania Oncology Hematology Associates
- Charleston Hematology-Oncology, P.A.
- Tri County Oncology Associates
- Santee Hematology Oncology
- Family Cancer Center
- Southwest Regional Cancer Center
- Danville Hematology and Oncology, Incorporated
- Virginia Oncology Care P.C.
- Western Washington Medical Group
Arms of the Study
Arm 1
Experimental
Study drug