Phase III Randomized Comparison Study of Vinorelbine, Gemcitabine, and Docetaxel Versus Paclitaxel and Carboplatin in Patients With Advanced Non-Small Cell Lung Cancer
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Masaaki Kawahara, MD
Study Chair
National Hospital Organization - Osaka National Hospital
United States: Federal Government
CDR0000355138
NCT00079287
March 2001
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