Perillyl Alcohol in Preventing Recurrent Breast Cancer in Women Who Have Been Treated With Surgery With or Without Adjuvant Therapy
|ClinicalTrials.gov 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
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|
- 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)|
|Official Title:||Multiple-Dose Phase I and Pharmacokinetic Trial of Perillyl Alcohol|
|Study Start Date :||June 2001|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00022425
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195-9001|
|Study Chair:||George Thomas Budd, MD||The Cleveland Clinic|