Pancreatic Cancer Clinical Trial
Official title:
A Phase I Trial of the Farnesyltransferase Inhibitor, R115777 (NSC# 702818) and Radiotherapy in Patients With Locally Advanced Pancreatic Cancer
RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary
for their growth and may make them more sensitive to radiation therapy. Radiation therapy
uses high-energy x-rays to damage tumor cells. Giving tipifarnib together with radiation
therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of tipifarnib when
given together with radiation therapy in treating patients with unresectable locally advanced
pancreatic cancer.
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and dose-limiting toxic effects of tipifarnib when
administered with radiotherapy in patients with unresectable locally advanced pancreatic
cancer.
Secondary
- Determine the 3-month clinical response in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of tipifarnib.
Patients receive oral tipifarnib once or twice daily on weeks 1-8. Patients also undergo
concurrent radiotherapy daily, 5 days a week, on weeks 2-8.
Cohorts of 3-6 patients receive escalating doses of tipifarnib until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.
Patients are followed at 1, 3, and 6 months.
PROJECTED ACCRUAL: A total of 8-18 patients will be accrued for this study within 12-15
months.
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