Paclitaxel With or Without Carboplatin in Treating Patients With Advanced 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, squamous cell lung cancer, large cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically proven non-small cell lung cancer (adenocarcinoma, large cell, squamous cell, or mixture) Stage IIIB due to any of the following: Malignant pleural effusion Supraclavicular node involvement Contralateral hilar node involvement Not eligible for CALGB protocols of combined therapy and chest irradiation Stage IV Any stage that has recurred or progressed after surgery or radiotherapy Measurable or evaluable disease Does not include the following: Bone metastases Pleural or peritoneal effusions Irradiated lesions, unless progression documented after radiation therapy No CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CALGB 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT less than 2 times the upper limit of normal (ULN) Renal: Creatinine no greater than 2 times ULN Other: No prior or concurrent malignancy except: Curatively treated carcinoma in situ of the cervix Curatively treated breast cancer Curatively treated basal cell or squamous cell skin cancer At least 5 years since any nonrecurrent primary tumor surgically resected without administration of adjuvant radiation therapy or chemotherapy HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: No concurrent hormones except steroids for adrenal failure, hormones for nondisease related conditions (e.g., insulin for diabetes), or dexamethasone Radiotherapy: At least 2 weeks since prior radiotherapy See Disease Characteristics Surgery: Prior surgery allowed See Disease Characteristics
Sites / Locations
- University of California San Diego Cancer Center
- UCSF Cancer Center and Cancer Research Institute
- CCOP - Christiana Care Health Services
- Walter Reed Army Medical Center
- CCOP - Mount Sinai Medical Center
- Mount Sinai Comprehensive Cancer Center
- University of Illinois at Chicago Health Sciences Center
- University of Chicago Cancer Research Center
- University of Iowa Hospitals and Clinics
- Marlene & Stewart Greenebaum Cancer Center, University of Maryland
- Dana-Farber Cancer Institute
- University of Massachusetts Memorial Medical Center
- Ellis Fischel Cancer Center - Columbia
- Barnes-Jewish Hospital
- University of Nebraska Medical Center
- CCOP - Southern Nevada Cancer Research Foundation
- Norris Cotton Cancer Center
- Roswell Park Cancer Institute
- CCOP - North Shore University Hospital
- North Shore University Hospital
- Memorial Sloan-Kettering Cancer Center
- New York Presbyterian Hospital - Cornell Campus
- Mount Sinai Medical Center, NY
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
- State University of New York - Upstate Medical University
- Lineberger Comprehensive Cancer Center, UNC
- Duke Comprehensive Cancer Center
- CCOP - Southeast Cancer Control Consortium
- Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
- Rhode Island Hospital
- Medical University of South Carolina
- University of Tennessee, Memphis Cancer Center
- Vermont Cancer Center
- Massey Cancer Center
- MBCCOP - Massey Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Paclitaxel
Paclitaxel + Carboplatin
Patients receive paclitaxel IV over 3 hours on day 1 of each course. Treatment is repeated every 21 days for 6 courses in the absence of tumor progression or unacceptable toxicity. Quality of life assessments are conducted before treatment and at 2, 6, 9, and 12 months. Patients are followed every 3 months for 2 years, then every 6 months until disease progression or death.
Patients receives paclitaxel as in Arm I, followed by carboplatin IV over 1 hour. Treatment is repeated every 21 days for 6 courses in the absence of tumor progression or unacceptable toxicity. Quality of life assessments are conducted before treatment and at 2, 6, 9, and 12 months. Patients are followed every 3 months for 2 years, then every 6 months until disease progression or death.