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
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 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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Michael Smylie, MD, MB, ChB
Study Chair
Cross Cancer Institute at University of Alberta
Canada: Health Canada
BR18
NCT00006229
April 2000
February 2009
Name | Location |
---|---|
Baptist Regional Cancer Center - Knoxville | Knoxville, Tennessee 37901 |
University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
Jackson-Madison County General Hospital | Jackson, Tennessee 38301 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Scripps Clinic | La Jolla, California 92037 |
Lahey Clinic - Burlington | Burlington, Massachusetts 01805 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
Creighton University Cancer Center | Omaha, Nebraska 68131-2197 |
Carle Cancer Center | Urbana, Illinois 61801 |
Saint Thomas Hospital | Nashville, Tennessee 37205 |
Queen's Medical Center | Honolulu, Hawaii 96813 |
Erlanger Health Systems | Chattanooga, Tennessee 37403 |
Williamson Medical Center | Franklin, Tennessee 37067 |
Central Georgia Hematology Oncology, P.C. | Macon, Georgia 31201 |
Duke University Medical Center | Durham, North Carolina 27710 |
Memorial Hospital Cancer Center - Chattanooga | Chattanooga, Tennessee 37404 |
Meharry Medical College | Nashville, Tennessee 37208-3599 |
Division of Medical Oncology - Vanderbilt | Nashville, Tennessee 37232-5536 |