Vinorelbine, Gemcitabine, and Docetaxel Compared With Paclitaxel and Carboplatin in Treating Patients With Advanced Non-Small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00079287|
Recruitment Status : Completed
First Posted : March 10, 2004
Last Update Posted : September 17, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: carboplatin Drug: docetaxel Drug: gemcitabine hydrochloride Drug: paclitaxel Drug: vinorelbine tartrate||Phase 3|
- 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.
- 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.
|Study Type :||Interventional (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|
|Study Start Date :||March 2001|
|Study Completion Date :||November 2008|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00079287
|Nagoya University Hospital|
|Aichi, Japan, 466-8560|
|Asahikawa Medical College|
|Asahikawa, Japan, 078 8510|
|National Cancer Center Hospital East|
|Chiba-ken, Japan, 277-8577|
|National Hospital Organization - Ehime National Hospital|
|Ehime, Japan, 791-0281|
|Aso Iizuka Hospital|
|Fukuoka, Japan, 820-0018|
|National Hospital Organization - Medical Center of Kure|
|Hiroshima, Japan, 737-0023|
|National Hospital Organization - Dohoku National Hospital|
|Hokkaido, Japan, 070-0901|
|Fujisawa City Hospital|
|Kanagawa, Japan, 251-8550|
|National Hospital Organization - Kochi Hospital|
|Kochi-shi, Japan, 780-8065|
|Kyoto, Japan, 615-8256|
|Ogaki Municipal Hospital|
|Ogaki-shi, Japan, 503-8502|
|National Hospital Organization - Okayama Medical Center|
|Okayama, Japan, 701-1192|
|National Hospital Organization - Okinawa Hospital|
|Okinawa, Japan, 901-2214|
|Osaka General Medical Center|
|Osaka-shi, Japan, 558-0056|
|Osaka Saiseikai Nakatsu Hospital|
|Osaka, Japan, 530-0012|
|Takatsuki Red Cross Hospital|
|Osaka, Japan, 569-1096|
|National Hospital Organization - Osaka National Hospital|
|Osaka, Japan, 591-8555|
|Saitama Cancer Center|
|Saitama, Japan, 362-0803|
|Takamatsu Red Cross Hospital|
|Takamatsu, Japan, 760-8571|
|Tokyo Medical and Dental University|
|Tokyo, Japan, 113-8519|
|Tokyo Medical University|
|Tokyo, Japan, 160|
|Tottori University Hospital|
|Tottori, Japan, 683-8504|
|Toyama Medical and Pharmaceutical University Hospital|
|Toyama, Japan, 930-0194|
|Koseiren Takaoka Hospital|
|Toyama, Japan, 933-8555|
|Study Chair:||Masaaki Kawahara, MD||National Hospital Organization - Osaka National Hospital|