Vinorelbine, Gemcitabine, and Docetaxel Compared With Paclitaxel and Carboplatin in Treating Patients With Advanced Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00079287
- Lead Sponsor
- Japan Multinational Trial Organization
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (24)
Nagoya University Hospital
🇯🇵Aichi, Japan
Asahikawa Medical College
🇯🇵Asahikawa, Japan
National Hospital Organization - Ehime National Hospital
🇯🇵Ehime, Japan
Tokyo Medical and Dental University
🇯🇵Tokyo, Japan
Tokyo Medical University
🇯🇵Tokyo, Japan
National Hospital Organization - Okayama Medical Center
🇯🇵Okayama, Japan
National Hospital Organization - Okinawa Hospital
🇯🇵Okinawa, Japan
Ogaki Municipal Hospital
🇯🇵Ogaki-shi, Japan
Toyama Medical and Pharmaceutical University Hospital
🇯🇵Toyama, Japan
Osaka Saiseikai Nakatsu Hospital
🇯🇵Osaka, Japan
Takatsuki Red Cross Hospital
🇯🇵Osaka, Japan
National Hospital Organization - Dohoku National Hospital
🇯🇵Hokkaido, Japan
National Cancer Center Hospital East
🇯🇵Chiba-ken, Japan
Fujisawa City Hospital
🇯🇵Kanagawa, Japan
National Hospital Organization - Kochi Hospital
🇯🇵Kochi-shi, Japan
Osaka General Medical Center
🇯🇵Osaka-shi, Japan
Takamatsu Red Cross Hospital
🇯🇵Takamatsu, Japan
Tottori University Hospital
🇯🇵Tottori, Japan
Koseiren Takaoka Hospital
🇯🇵Toyama, Japan
Aso Iizuka Hospital
🇯🇵Fukuoka, Japan
National Hospital Organization - Medical Center of Kure
🇯🇵Hiroshima, Japan
Kyoto-Katsura Hospital
🇯🇵Kyoto, Japan
Saitama Cancer Center
🇯🇵Saitama, Japan
National Hospital Organization - Osaka National Hospital
🇯🇵Osaka, Japan