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

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

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

Inclusion 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

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Patrick J. Loehrer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Indiana University Melvin and Bren Simon Cancer Center


United States: Federal Government

Study ID:

9710-07; T98-0046



Start Date:

February 1999

Completion Date:

July 2001

Related Keywords:

  • Pancreatic Cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • adenocarcinoma of the pancreas
  • Pancreatic Neoplasms



Indiana University Cancer Center Indianapolis, Indiana  46202-5265