Spots Global Cancer Trial Database for Gemcitabine With or Without CI-994 in Treating Patients With Advanced Pancreatic Cancer
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Trial Identification
Brief Title: Gemcitabine With or Without CI-994 in Treating Patients With Advanced Pancreatic Cancer
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of CI-994 Capsules Plus Gemcitabine Infusion Versus Placebo Capsules Plus Gemcitabine Infusion in the Treatment of Patients With Advanced Pancreatic Cancer
Study ID: NCT00004861
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. Combining more than one drug or giving drugs in different ways may kill more tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of gemcitabine with or without CI-994 in treating patients who have advanced pancreatic cancer.
Detailed Description: OBJECTIVES: I. Determine the efficacy and safety of CI-994 given in combination with gemcitabine compared to gemcitabine alone in the treatment of patients with advanced pancreatic cancer. OUTLINE: Gemcitabine is the standard of care for pancreatic cancer and is administered by intravenous injection. Patients receive gemcitabine once a week for 3 weeks followed by 1 week of rest. Patients take the capsules (placebo or investigational chemotherapy) daily for 21 consecutive days beginning with the first gemcitabine infusion. The duration of treatment is determined by the patient's tolerance of therapy and the assessment of disease response. PROJECTED ACCRUAL: A total of 172 patients will be enrolled in Canada, Europe, and the United States on a competitive basis.
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
Sinai Hospital of Baltimore, Baltimore, Maryland, United States
William Beaumont Hospital, Royal Oak, Michigan, United States
Raleigh Hematology/Oncology Associates - Wake Practice, Raleigh, North Carolina, United States
Jewish Hospital of Cincinnati, Inc., Cincinnati, Ohio, United States
Ireland Cancer Center, Cleveland, Ohio, United States
West Clinic, P.C., Memphis, Tennessee, United States
Sarah Cannon-Minnie Pearl Cancer Center, Nashville, Tennessee, United States
Tyler Cancer Center, Tyler, Texas, United States
Northern Virginia Oncology Group, Fairfax, Virginia, United States
St. Boniface General Hospital, Winnipeg, Manitoba, Canada
Nova Scotia Cancer Centre, Halifax, Nova Scotia, Canada
Cancer Care Ontario-London Regional Cancer Centre, London, Ontario, Canada
Ottawa Regional Cancer Center - General Division, Ottawa, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada
Contact Details
Name: Kathy M. Diener, PharmD
Affiliation: Pfizer Incorporated - Ann Arbor
Role: STUDY_CHAIR
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