Perillyl Alcohol in Treating Patients With Metastatic Breast Cancer

Trial Information

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

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.

Inclusion Criteria

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Howard H. Bailey, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Federal Government

Study ID:

CDR0000066080

NCT ID:

NCT00003219

Start Date:

May 1998

Completion Date: