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
- 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
- Compare the progression free survival of patients treated with these regimens. (Phase
- Correlate the expression of serum/plasma and tissue matrix metalloproteinases (MMP)
levels and other markers with outcomes and response in patients treated with these
- 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
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.
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
Cross Cancer Institute at University of Alberta
Canada: Health Canada
|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|