Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006229
Status:
COMPLETED
Last Update Posted:
2020-04-06
First Post:
2000-09-11
Brief Title:
Paclitaxel Carboplatin Withut BMS-275291 in Advanced or Metastatic Non-small Cell Lung Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase IIIII Double Blind Randomized Trial of BMS-275291 vs Placebo in Patients Receiving PaclitaxelCarboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2020-04
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 use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known whether paclitaxel and carboplatin are more effective with or without BMS-275291 for non-small cell lung cancer
PURPOSE Randomized phase IIIII trial to compare the effectiveness of paclitaxel and carboplatin with or without BMS-275291 in treating patients who have advanced or metastatic non-small cell lung cancer
PURPOSE Randomized phase IIIII trial to compare the effectiveness of paclitaxel and carboplatin with or without BMS-275291 in treating patients who have advanced or metastatic non-small cell lung cancer
Detailed Description:
OBJECTIVES
Compare the overall survival of patients with advanced or metastatic non-small cell lung cancer treated with paclitaxel and carboplatin with or without BMS-275291
Compare the incidence of grade 2 or higher drug related arthritis arthralgia andor myalgia in patients treated with these regimens Phase II only
Compare the objective tumor response rate time to response and response duration in patients treated with these regimens
Compare the nature severity and frequency of toxic effects of these regimens in these patients
Compare the progression free survival of patients treated with these regimens Phase III only
Correlate the expression of serumplasma and tissue matrix metalloproteinases MMP levels and other markers with outcomes and response in patients treated with these regimens
Compare quality of life of patients treated with these regimens
OUTLINE This is a randomized double blind placebo controlled multicenter study Patients are stratified according to center disease stage IIIB vs IV and ECOG performance status 0-1 vs 2 Patients are randomized to one of two treatment arms
Arm I Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 plus oral BMS-275291 daily on days 1-21
Arm II Patients receive paclitaxel and carboplatin as in arm I plus oral placebo daily on days 1-21
Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity BMS-275291 or placebo continues beyond 8 courses in the absence of disease progression
Quality of life is assessed
Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 776 patients will be accrued for this study within 27 months
Compare the overall survival of patients with advanced or metastatic non-small cell lung cancer treated with paclitaxel and carboplatin with or without BMS-275291
Compare the incidence of grade 2 or higher drug related arthritis arthralgia andor myalgia in patients treated with these regimens Phase II only
Compare the objective tumor response rate time to response and response duration in patients treated with these regimens
Compare the nature severity and frequency of toxic effects of these regimens in these patients
Compare the progression free survival of patients treated with these regimens Phase III only
Correlate the expression of serumplasma and tissue matrix metalloproteinases MMP levels and other markers with outcomes and response in patients treated with these regimens
Compare quality of life of patients treated with these regimens
OUTLINE This is a randomized double blind placebo controlled multicenter study Patients are stratified according to center disease stage IIIB vs IV and ECOG performance status 0-1 vs 2 Patients are randomized to one of two treatment arms
Arm I Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 plus oral BMS-275291 daily on days 1-21
Arm II Patients receive paclitaxel and carboplatin as in arm I plus oral placebo daily on days 1-21
Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity BMS-275291 or placebo continues beyond 8 courses in the absence of disease progression
Quality of life is assessed
Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 776 patients will be accrued for this study within 27 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CAN-NCIC-BR18 | OTHER | None | None |
| BMS-CA161-003 | OTHER | None | None |
| CDR0000068153 | OTHER | PDQ | None |