Lung Cancer Clinical Trial
Official title:
Phase III Randomized Comparison Study of Vinorelbine, Gemcitabine, and Docetaxel Versus Paclitaxel and Carboplatin in Patients With Advanced Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as vinorelbine, gemcitabine, docetaxel,
paclitaxel, and carboplatin, work in different ways to stop tumor cells from dividing so
they stop growing or die. Combining more than one drug may kill more tumor cells. It is not
yet known which combination chemotherapy regimen is more effective in treating non-small
cell lung cancer.
PURPOSE: This randomized phase III trial is studying how well giving vinorelbine together
with gemcitabine and docetaxel works compared to giving paclitaxel together with carboplatin
in treating patients with stage IIIB, stage IV, or recurrent 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.
;
Allocation: Randomized, Primary Purpose: Treatment
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