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A Phase II Trial of Perillyl Alcohol in Patients With Resectable Pancreatic Cancer (NCT00003769)

National Cancer Institute (NCI)
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.
  • Drug: perillyl alcohol
    • Procedure: surgical procedure
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      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.

      1 locations

      United States (1)
      • Indiana University Cancer Center
        Not specified
        Indianapolis, Indiana, United States, 46202-5289
      Status:
      completed
      Type:
      Interventional
      Phase:
      Start:
      31 January, 1999
      Updated:
      08 September, 2014
      Participants:
      0
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