Perillyl Alcohol in Preventing Recurrent Breast Cancer in Women Who Have Been Treated With Surgery With or Without Adjuvant Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00022425
Recruitment Status : Unknown
Verified September 2003 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : December 18, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the recurrence of cancer. The use of perillyl alcohol may be effective in preventing the recurrence of breast cancer.

PURPOSE: Phase I trial to study the effectiveness of perillyl alcohol in preventing the recurrence of breast cancer in women who have been treated with surgery with or without adjuvant therapy.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: perillyl alcohol Phase 1

Detailed Description:


  • Determine the maximum tolerated dose of perillyl alcohol in women at risk for recurrent breast cancer.
  • Determine the toxicity of this drug in these patients.
  • Determine the single-dose and multiple-dose pharmacokinetics of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive oral perillyl alcohol once daily on days 1-28. Treatment continues every 4 weeks for 3 courses.

Cohorts of 6 patients receive escalating doses of perillyl alcohol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience grade 1 toxicity or at least 1 of 6 patients experience grade 2 or greater toxicity.

Patients are followed weekly.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Prevention
Official Title: Multiple-Dose Phase I and Pharmacokinetic Trial of Perillyl Alcohol
Study Start Date : June 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Personal history of stage Tis, I, II, or IIIA breast cancer
  • Previously treated with definitive resection with curative intent
  • Hormone receptor status:

    • Not specified



  • Over 18


  • Female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified


  • WBC at least 3,000/mm3
  • Platelet count at least 100,000/mm3
  • Hemoglobin at least 9.0 g/dL


  • Bilirubin no greater than 1.5 mg/dL
  • AST and ALT no greater than 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 1.5 times ULN


  • Creatinine no greater than 1.6 mg/dL


  • No known malabsorption syndrome
  • No contraindication to perillyl alcohol
  • No hypersensitivity to citrus or soybean products
  • No non-breast malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ
  • No active malignancy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • Not specified


  • At least 6 months since prior chemotherapy

Endocrine therapy:

  • Concurrent adjuvant hormonal therapy allowed


  • At least 6 months since prior radiotherapy


  • See Disease Characteristics
  • At least 6 months since prior surgery
  • At least 2 years since prior primary surgery
  • More than 4 weeks since prior surgery requiring general anesthesia, including breast reconstructive surgery


  • More than 3 months since prior enrollment in a single-dose study of perillyl alcohol
  • More than 3 months since prior enrollment in current study (at a lower dose level)
  • No concurrent vitamin supplements except a daily multivitamin (recommended daily allowance)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00022425

United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195-9001
Sponsors and Collaborators
The Cleveland Clinic
National Cancer Institute (NCI)
Study Chair: George Thomas Budd, MD The Cleveland Clinic Identifier: NCT00022425     History of Changes
Other Study ID Numbers: CDR0000068816
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: September 2003

Keywords provided by National Cancer Institute (NCI):
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Perillyl alcohol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action