Perillyl Alcohol Followed by Surgery in Treating Patients With Stage II or Stage III Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: Phase II trial to study the effectiveness of perillyl alcohol followed by surgery in treating patients who have stage II or stage III pancreatic cancer.
|Pancreatic Cancer||Drug: perillyl alcohol Procedure: surgical procedure||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Trial of Perillyl Alcohol in Patients With Resectable Pancreatic Cancer|
|Study Start Date:||February 1999|
|Study Completion Date:||July 2001|
|Primary Completion Date:||July 2001 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003769
|United States, Indiana|
|Indiana University Cancer Center|
|Indianapolis, Indiana, United States, 46202-5289|
|Study Chair:||Patrick J. Loehrer, MD||Indiana University Melvin and Bren Simon Cancer Center|