ICH GCP | Clinical Trials Registry

Southwest Oncology Group 

National Cancer Institute (NCI) 

DISEASE CHARACTERISTICS: - Histologically or cytologically proven newly diagnosed advanced primary non-small cell lung cancer (NSCLC), including the following cellular types: - Adenocarcinoma - Large cell carcinoma - Squamous cell carcinoma - Unspecified carcinoma OR - Recurrent disease after prior surgery and/or radiotherapy - Stage IIIB disease - T4 lesion due to malignant pleural effusion OR - Stage IV disease - Any T, any N, M1 (distant metastasis, including lesions in multiple lobes of the ipsilateral lung) - Measurable or evaluable disease - Pleural effusions, ascites, and laboratory parameters not considered as only evidence of disease - Must be outside prior radiated field or area of prior surgical resection or new lesion must be present - No known brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Zubrod 0-1 Life expectancy: - Not specified Hematopoietic: - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL Hepatic: - Bilirubin no greater than 2 times upper limit of normal (ULN) - SGOT or SGPT no greater than 2 times ULN - Alkaline phosphatase no greater than 2 times ULN Renal: - Creatinine no greater than ULN - Creatinine clearance at least 50 mL/min Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No peripheral neuropathy (motor or sensory) of grade 2 or greater - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I/II cancer in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior biologic therapy for NSCLC Chemotherapy: - No prior systemic chemotherapy for NSCLC Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - At least 3 weeks since prior radiotherapy and recovered - No concurrent radiotherapy Surgery: - See Disease Characteristics - At least 2 weeks since prior thoracic or other major surgery and recovered

All

18 Years

N/A

No

United States

Randomized

Treatment