A Phase II Trial of Perillyl Alcohol in Patients With Resectable Pancreatic Cancer
OBJECTIVES: I. Assess the biologic activity of perillyl alcohol in patients with potentially
resectable, stage II or stage III pancreatic adenocarcinoma. II. Characterize the acute
toxicity of this drug in these patients. III. Evaluate the antitumor activity of this drug
in these patients. IV. Monitor and quantitate the plasma levels of perillyl alcohol after
oral administration in this patient population.
OUTLINE: Patients receive oral perillyl alcohol 4 times daily on days 1-14. Patients undergo
surgical resection on day 15. There is no continuation of perillyl alcohol postoperatively.
Patients are followed at a minimum of 2 and 4 months following surgery.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 12-18
months.
Interventional
Primary Purpose: Treatment
Patrick J. Loehrer, MD
Study Chair
Indiana University Melvin and Bren Simon Cancer Center
United States: Federal Government
9710-07; T98-0046
NCT00003769
February 1999
July 2001
Name | Location |
---|---|
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |