Spots Global Cancer Trial Database for Gemcitabine With or Without CI-994 in Treating Patients With Advanced Non-small Cell Lung Cancer
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Trial Identification
Brief Title: Gemcitabine With or Without CI-994 in Treating Patients With Advanced Non-small Cell Lung Cancer
Official Title: 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
Study ID: NCT00005093
Conditions
Study Description
Brief Summary: 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 gemcitabine plus CI-994 is more effective than gemcitabine alone for non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or without CI-994 in treating patients who have advanced non-small cell lung cancer.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cedars-Sinai Comprehensive Cancer Center, Los Angeles, California, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
New England Medical Center Hospital, Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Raleigh Hematology/Oncology Associates - Wake Practice, Raleigh, North Carolina, United States
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States
West Clinic, P.C., Memphis, Tennessee, United States
Southwest Regional Cancer Center, Austin, Texas, United States
Cross Cancer Institute, Edmonton, Alberta, Canada
British Columbia Cancer Agency - Fraser Valley Cancer Centre, Surrey, British Columbia, Canada
BC Cancer Agency, Vancouver, British Columbia, Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre, Victoria, British Columbia, Canada
Ottawa Regional Cancer Center - General Division, Ottawa, Ontario, Canada
Mount Sinai Hospital - Toronto, Toronto, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Contact Details
Name: Kathryn Kimmel, PhD
Affiliation: Pfizer Incorporated - Ann Arbor
Role: STUDY_CHAIR
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