Phase III Randomized Comparison Study of Vinorelbine, Gemcitabine, and Docetaxel Versus Paclitaxel and Carboplatin in Patients With Advanced Non-Small Cell Lung Cancer
Data Collection
Bronchial Neoplasms+7
+ Carcinoma, Bronchogenic
+ Carcinoma, Non-Small-Cell Lung
Treatment Study
Summary
Study start date: March 1, 2001
Actual date on which the first participant was enrolled.OBJECTIVES: Primary * Compare the therapeutic effect of vinorelbine, gemcitabine, and docetaxel vs paclitaxel and carboplatin in patients with advanced non-small cell lung cancer. * Compare the overall survival of patients treated with these regimens. Secondary * Compare the response rate in patients treated with these regimens. * Compare the toxicity of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive vinorelbine IV and gemcitabine IV on days 1 and 8. Treatment repeats every 21 days for 3 courses. Patients then receive docetaxel IV on day 1. Treatment repeats every 21 days for 3 courses. * Arm II: Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 21 days for 6 courses. Patients are followed for 1 year. PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study within 2 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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)
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 24 locations
Asahikawa Medical College
Asahikawa, JapanNational Cancer Center Hospital East
Chiba-ken, JapanNational Hospital Organization - Ehime National Hospital
Ehime, Japan