Multiple-Dose Phase I and Pharmacokinetic Trial of Perillyl Alcohol
18 Years
N/A
Female
Breast Cancer
Trial Information
Multiple-Dose Phase I and Pharmacokinetic Trial of Perillyl Alcohol
OBJECTIVES:
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Personal history of stage Tis, I, II, or IIIA breast cancer
- Previously treated with definitive resection with curative intent
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- Over 18
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin at least 9.0 g/dL
Hepatic:
- 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
Renal:
- Creatinine no greater than 1.6 mg/dL
Other:
- 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
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 6 months since prior chemotherapy
Endocrine therapy:
- Concurrent adjuvant hormonal therapy allowed
Radiotherapy:
- At least 6 months since prior radiotherapy
Surgery:
- 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
Other:
- 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)
Type of Study:
Interventional
Study Design:
Primary Purpose: Prevention
Principal Investigator
George Thomas Budd, MD
Investigator Role:
Study Chair
Investigator Affiliation:
The Cleveland Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000068816
NCT ID:
NCT00022425
Start Date:
June 2001
Completion Date:
Related Keywords:
- Breast Cancer
- recurrent breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
