Gemcitabine With or Without CI-994 in Treating Patients With Advanced Non-small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00005093
- Lead Sponsor
- Pfizer
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
New England Medical Center Hospital
🇺🇸Boston, Massachusetts, United States
BC Cancer Agency
🇨🇦Vancouver, British Columbia, Canada
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Mount Sinai Hospital - Toronto
🇨🇦Toronto, Ontario, Canada
West Clinic, P.C.
🇺🇸Memphis, Tennessee, United States
British Columbia Cancer Agency - Vancouver Island Cancer Centre
🇨🇦Victoria, British Columbia, Canada
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Raleigh Hematology/Oncology Associates - Wake Practice
🇺🇸Raleigh, North Carolina, United States
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Cedars-Sinai Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Southwest Regional Cancer Center
🇺🇸Austin, Texas, United States
British Columbia Cancer Agency - Fraser Valley Cancer Centre
🇨🇦Surrey, British Columbia, Canada
Ottawa Regional Cancer Center - General Division
🇨🇦Ottawa, Ontario, Canada