Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00079287
Status:
COMPLETED
Last Update Posted:
2013-09-17
First Post:
2004-03-08
Brief Title:
Vinorelbine Gemcitabine and Docetaxel Compared With Paclitaxel and Carboplatin in Treating Patients With Advanced Non-Small Cell Lung Cancer
Sponsor:
Japan Multinational Trial Organization
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2005-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| JMTO-LC00-03 | None | None | None |