Perillyl Alcohol in Treating Patients With Metastatic Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II Trial of Perillyl Alcohol (NSC 641066) Administered Daily in Patients With Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: perillyl alcohol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: perillyl alcohol|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer, recurrent breast cancer