Polyglutamate Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Treating Patients With Advanced or Recurrent 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 IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) meeting 1 of the following criteria: Locally advanced or recurrent disease previously treated with radiotherapy and/or surgery Stage IIIB and not a candidate for combined modality therapy Stage IV No evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology Cytological diagnosis must be based on the following: No cellular diagnosis by sputum cytology alone Cytologic specimens obtained from brushings, washings, or needle aspiration of a defined lesion or pleural effusion are acceptable Measurable or nonmeasurable disease 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: Neurologic function stable for 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 2 Life expectancy Not specified 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) SGOT/SGPT no greater than 2.5 times ULN (5 times ULN if liver metastases present) Alkaline phosphatase no greater than 2.5 times ULN (except for laboratory documentation that demonstrates bone origin) Renal Creatinine no greater than 1.5 times ULN Cardiovascular No unstable angina No myocardial infarction within the past 6 months Cardiac conduction abnormalities (e.g., bundle branch block or heart block) allowed provided cardiac status has been stable for at least 6 months prior to study entry Neurologic See Disease Characteristics No neuropathy greater than grade 1 No evidence of unstable neurological symptoms within the past 4 weeks (2 weeks for neurological symptoms due to brain metastases) Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No intolerance to excipients of polyglutamate paclitaxel (e.g., poly-L-glutamic acid, poloxamer 188, dibasic sodium phosphate, or monobasic sodium hydroxide) No clinically significant active infection No other concurrent primary malignancy except carcinoma in situ or nonmelanoma skin cancer No other unstable medical conditions No circumstance that would preclude study completion or follow-up PRIOR CONCURRENT THERAPY: Biologic therapy No prior systemic biologic agent for lung cancer Chemotherapy See Disease Characteristics No prior systemic therapy for lung cancer including radiosensitizing agents Endocrine therapy See Disease Characteristics Radiotherapy See Disease Characteristics No concurrent radiotherapy Surgery See Disease Characteristics Recovered from prior major surgery Other More than 12 weeks since prior participation in any research study or treatment with investigational drugs Recovered from prior investigational therapy or stable for 4 weeks before study treatment No other concurrent investigational drugs No other concurrent systemic antitumor therapy No concurrent amifostine Concurrent bisphosphonates allowed
Sites / Locations
- Hematology and Oncology Associates of Alabama
- Clinical Research Consultants, Inc
- Arizona Clinical Research Center
- Synergy Hematology/Oncology Medical Associates
- Holy Cross Providence Cancer Center
- Clinical Trials and Research Associates, Incorporated
- California Hematology/Oncology Medical Group
- Hematology Oncology, P.C.
- New Hope Cancer Centers
- Omni Healthcare, PA
- MetCare Oncology
- Hematology Oncology Associates of theTreasure Coast - Port St. Lucie
- Northwest Georgia Oncology Centers, P.C.
- Georgia Cancer Specialists - Tucker
- Silver Cross Hospital
- Gross Point Medical Center
- Kentucky Cancer Clinic
- Hattiesburg Clinic, P.A.
- Columbia Comprehensive Cancer Care Clinic
- Bond Clinic
- Las Vegas Cancer Center
- Summit Medical Group, P.A.
- Gabrail Cancer Center - Canton Office
- Oklahoma Oncology, Inc. - St. John Campus
- Charleston Cancer Center
- Santee Hematology Oncology
- Clarksville Regional Hematology/Oncology Group
- Family Cancer Center
- University of Texas - MD Anderson Cancer Center
- Cancer Therapy and Research Center
- Virginia Oncology Care P.C.
- Highline Medical Oncology
- Rainier Oncology
- Cross Cancer Institute