Paclitaxel and Carboplatin With or Without BMS-275291 in Treating Patients With Advanced or Metastatic Non-small Cell Lung Cancer
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 II/III 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Phase II/III Double Blind Randomized Trial of BMS-275291 vs. Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-small Cell Lung Cancer|
|Study Start Date:||April 2000|
|Study Completion Date:||February 2009|
|Primary Completion Date:||December 2003 (Final data collection date for primary outcome measure)|
|Experimental: BMS-275291||Drug: carboplatin Drug: paclitaxel Drug: rebimastat|
|Placebo Comparator: Placebo||Drug: carboplatin Drug: paclitaxel|
- 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 and/or 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 serum/plasma 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006229
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|Study Chair:||Michael Smylie, MD, MB, ChB||Cross Cancer Institute at University of Alberta|