Perillyl Alcohol Followed by Surgery in Treating Patients With Stage II or Stage III Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

A Phase II Trial of Perillyl Alcohol in Patients With Resectable Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003769
• Other study ID #: 9710-07; T98-0046
• Secondary ID: IUMC-9710-07NCI-
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: September 9, 2014
• Start date: February 1999
• Est. completion date: July 2001

Study information

• Verified date: September 2014
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2001
• Est. primary completion date: July 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• perillyl alcohol

Procedure:
• surgical procedure

Locations

Country	Name	City	State
United States	Indiana University Cancer Center	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University School of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,