Vinorelbine, Gemcitabine, and Docetaxel Compared With Paclitaxel and 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 adenocarcinoma of the lung, large cell lung cancer, recurrent non-small cell lung cancer, squamous 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 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)
Sites / Locations
- Nagoya University Hospital
- Asahikawa Medical College
- National Cancer Center Hospital East
- National Hospital Organization - Ehime National Hospital
- Aso Iizuka Hospital
- National Hospital Organization - Medical Center of Kure
- National Hospital Organization - Dohoku National Hospital
- Fujisawa City Hospital
- National Hospital Organization - Kochi Hospital
- Kyoto-Katsura Hospital
- Ogaki Municipal Hospital
- National Hospital Organization - Okayama Medical Center
- National Hospital Organization - Okinawa Hospital
- Osaka General Medical Center
- Osaka Saiseikai Nakatsu Hospital
- Takatsuki Red Cross Hospital
- National Hospital Organization - Osaka National Hospital
- Saitama Cancer Center
- Takamatsu Red Cross Hospital
- Tokyo Medical and Dental University
- Tokyo Medical University
- Tottori University Hospital
- Toyama Medical and Pharmaceutical University Hospital
- Koseiren Takaoka Hospital