RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have locally advanced or metastatic pancreatic cancer.
OBJECTIVES: I. Determine the six month survival rate in patients with advanced adenocarcinoma of the pancreas treated with R115777. II. Determine the time to treatment failure and confirmed response in this patient population treated with this regimen. III. Evaluate the frequency and severity of toxicities associated with this treatment regimen in these patients. OUTLINE: Patients receive oral R115777 twice daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 2 years and then annually thereafter. PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
300mg/dose BID, PO, Days 1-21, q 28days
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States
University of California Davis Medical Center
Survival rate in patients with advanced adenocarcinoma of the pancreas treated with R115777
Time frame: 6 months
Time to treatment failure
Time frame: Once every 8 weeks until progression
Evaluate the frequency and severity of toxicities
Time frame: Weekly for 8 weeks and then once every 4 weeks
Assess confirmed response (complete & partial) in patients with measurable advanced adenocarcinoma of the pancreas
Time frame: Once every 8 weeks
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