Phase III Randomized Comparison Study of Vinorelbine, Gemcitabine, and Docetaxel Versus Paclitaxel and Carboplatin in Patients With Advanced Non-Small Cell Lung Cancer

Date de début de l'étude : 1 mars 2001

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed primary non-small cell lung cancer (NSCLC) meeting criteria for 1 of the following: * Newly diagnosed selected stage IIIB (T4 lesion due to malignant pleural effusion) disease * Newly diagnosed stage IV disease * Recurrent disease after prior surgery and/or radiotherapy * The following cellular subtypes are allowed: * Adenocarcinoma * Large cell carcinoma * Squamous cell carcinoma * Unspecified carcinoma * Measurable or nonmeasurable disease by CT scan, MRI, x-ray, physical examination, or bone scintigraphy * Pleural effusions, ascites, and laboratory parameters are not allowed as the only evidence of disease * Disease must be present outside area of prior surgical resection * Disease must be present outside area of prior radiotherapy OR new lesion documented * No known brain metastases by CT scan or MRI within the past 6 weeks * No pleural or pericardial effusions requiring treatment PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * Absolute granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9 g/dL Hepatic * Bilirubin ≤ 2 times upper limit of normal (ULN) * SGOT or SGPT ≤ 2 times ULN * Alkaline phosphatase ≤ 2 times ULN Renal * Creatinine ≤ ULN * Creatinine clearance ≥ 50 mL/min Cardiovascular * No uncontrolled hypertension * No unstable angina * No congestive heart failure * No myocardial infarction within the past year * No ventricular arrhythmia requiring medical intervention Other * Not pregnant or nursing * Fertile patients must use effective contraception * No prior allergic drug reaction attributed to Cremophor or polysorbate 80 * No disorder associated with lung cancer with life-threatening consequences * No motor or sensory neuropathy ≥ grade 2 * 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 adequately treated stage I or II cancer currently in complete remission * No uncontrolled diabetes PRIOR CONCURRENT THERAPY: Biologic therapy * No prior biologic therapy for NSCLC Chemotherapy * No prior systemic chemotherapy for NSCLC Endocrine therapy * No prior or concurrent steroid-type hormonal therapy (e.g., ethinyl estradiol) Radiotherapy * See Disease Characteristics * At least 3 weeks since prior radiotherapy and recovered Surgery * See Disease Characteristics * At least 2 weeks since prior thoracic or other major surgery and recovered Other * No prior or concurrent azole antifungal therapy (e.g., ketoconazole, miconazole, or itraconazole) * No prior or concurrent macrolides (e.g., erythromycin or clarithromycin) * No prior or concurrent cyclosporine, terfenadine, benzodiazepines (e.g., diazepam, triazolam, or midazolam), or retinoids * No prior or concurrent calcium antagonists (e.g., diltiazem, nifedipine, or verapamil)