Pancreatic Cancer Clinical Trial
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
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.
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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