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Perillyl Alcohol in Treating Patients With Metastatic Breast Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison Identifier:
First received: November 1, 1999
Last updated: October 8, 2012
Last verified: October 2012

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of perillyl alcohol in treating patients with metastatic breast cancer that has not responded to previous chemotherapy.

Condition Intervention Phase
Breast Cancer
Drug: perillyl alcohol
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Trial of Perillyl Alcohol (NSC 641066) Administered Daily in Patients With Metastatic Breast Cancer

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Study Start Date: May 1998
Study Completion Date: May 1998
Primary Completion Date: May 1998 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine the clinical effectiveness (i.e., objective tumor response, time to treatment failure, and survival) of perillyl alcohol in patients with previously treated metastatic breast cancer. II. Define the acute and chronic toxic effects of perillyl alcohol in this patient population.

OUTLINE: Patients are given oral perillyl alcohol 4 times per day. Dose escalation of perillyl alcohol may occur in individual patients if no unacceptable toxicity is observed. Treatment is continued as long as the patient benefits from treatment, does not show progressive disease, and does not experience irreversible or life threatening toxicity. Patients are evaluated for response monthly while receiving treatment on this study. Patients are followed at 2-4 weeks after the last treatment.

PROJECTED ACCRUAL: Approximately 40 patients will be accrued over 2 years.


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

DISEASE CHARACTERISTICS: Microscopically confirmed metastatic breast cancer Must be refractory or have recurred after at least 1 systemic chemotherapy regimen Estrogen receptor positive tumors must have failed or recurred after hormonal therapy At least 1 site of measurable disease required Previously radiated lesions are not considered measurable unless there is evidence of disease progression after completion of radiation therapy No known brain metastases Hormone receptor status: Unspecified

PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 4000/mm3 Platelet count at least 100,000/mm3 Absolute neutrophil count at least 1500/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2 times normal Renal: Creatinine no greater than 1.5 mg/dL BUN no greater than 30 mg/dL Other: Effective birth control must be used by fertile patients (barrier method preferred) Not pregnant or nursing

PRIOR CONCURRENT THERAPY: Recovered from toxic effects of prior treatment Biologic therapy: No immunologic therapy within the past 2 weeks Chemotherapy: No chemotherapy within the past 4 weeks (6 weeks for mitomycin or nitrosoureas) See Disease Characteristics Endocrine therapy: No hormonal therapy within the past 2 weeks See Disease Characteristics Radiotherapy: No radiotherapy within the past 4 weeks See Disease Characteristics Surgery: Not specified Other: No concurrent cholesterol lowering agents, supplemental vitamins, or other antioxidants

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Please refer to this study by its identifier: NCT00003219

United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
National Cancer Institute (NCI)
Study Chair: Howard H. Bailey, MD University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison Identifier: NCT00003219     History of Changes
Other Study ID Numbers: CDR0000066080
R21CA072500 ( US NIH Grant/Contract Award Number )
Study First Received: November 1, 1999
Last Updated: October 8, 2012

Keywords provided by University of Wisconsin, Madison:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Perilla 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 processed this record on April 26, 2017