A Randomized Double-Blind, Placebo-Controlled, Multicenter Study of CI-994 Capsules Plus Gemcitabine Infusion Versus Placebo Capsules Plus Gemcitabine Infusion as Second-Line Treatment of Patients With Advanced Nonsmall Cell Lung Cancer
OBJECTIVES: I. Determine the efficacy and safety of gemcitabine with or without CI-994 in
patients with advanced non-small cell lung cancer.
OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients
are stratified according to performance status and are randomized to one of two treatment
arms. Arm I: Patients receive CI-994 orally on days 1-21 and gemcitabine IV over 30 minutes
on days 1, 8, and 15. Arm II: Patients receive placebo capsules orally on days 1-21 and
gemcitabine as in arm I. Treatment repeats every 28 days as long as medically appropriate
(absence of disease progression or unacceptable toxicity).
PROJECTED ACCRUAL: A total of 176 patients will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Kathryn Kimmel, PhD
Pfizer Incorporated - Ann Arbor
United States: Federal Government
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|Arthur G. James Cancer Hospital - Ohio State University||Columbus, Ohio 43210|
|New England Medical Center Hospital||Boston, Massachusetts 02111|
|Southwest Regional Cancer Center||Austin, Texas 78705|
|West Clinic, P.C.||Memphis, Tennessee 38117|
|Cedars-Sinai Comprehensive Cancer Center||Los Angeles, California 90048|
|Raleigh Hematology/Oncology Associates - Wake Practice||Raleigh, North Carolina 27609|