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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Kathryn Kimmel, PhD
Study Chair
Pfizer Incorporated - Ann Arbor
United States: Federal Government
PD-994-013
NCT00005093
December 1999
May 2001
Name | Location |
---|---|
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 |