A Phase II Trial of Perillyl Alcohol in Patients With Resectable Pancreatic Cancer
perillyl alcohol
+ surgical procedure
Digestive System Diseases+5
+ Digestive System Neoplasms
+ Endocrine System Diseases
Treatment Study
Summary
Study start date: February 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage II or stage III pancreatic adenocarcinoma that is considered resectable Lesions should be amenable to surgery with curative intent Bidimensionally measurable or evaluable disease No evidence of metastatic disease No clinically detectable third space fluid collections (e.g., ascites or effusions) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.5 g/dL Hepatic: Bilirubin no greater than 4 times upper limit of normal (ULN) PTT no greater than 1.5 times control (unless on anticoagulants) Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Fertile patients must use effective contraception No concurrent serious systemic disorders incompatible with study No active infection No second primary malignancy, previously untreated with curative intent or presently active, that would preclude curative resection of the pancreas PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for pancreatic carcinoma Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for pancreatic carcinoma Surgery: See Disease Characteristics Other: At least 1 month since prior investigational agents At least 72 hours since prior anticoagulant therapy, cholesterol-lowering agents (e.g., lovastatin), high dosage vitamins, or antioxidants No concurrent anticoagulants except for the sole purpose of central line patency maintenance No other concurrent investigational agents
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Indiana University Cancer Center
Indianapolis, United StatesOpen Indiana University Cancer Center in Google Maps