A Phase I Trial of the Farnesyltransferase Inhibitor, R115777 (NSC# 702818) and Radiotherapy in Patients With Locally Advanced Pancreatic Cancer
- Determine the maximum tolerated dose and dose-limiting toxic effects of tipifarnib when
administered with radiotherapy in patients with unresectable locally advanced
- 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
Primary Purpose: Treatment
Stephen Michael Hahn, MD
Abramson Cancer Center of the University of Pennsylvania
United States: Food and Drug Administration
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|