Perillyl Alcohol in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
RATIONALE: Drugs used in chemotherapy use different way 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 prostate cancer that has not responded to hormone therapy with androgens.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Trial of Perillyl Alcohol (NSC 641066) Administered Daily In Patients With Metastatic Androgen Independent Prostate Cancer|
|Study Start Date:||February 1998|
|Primary Completion Date:||October 2001 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Evaluate the clinical effectiveness of oral perillyl alcohol given to patients with androgen independent metastatic prostate cancer. II. Assess the toxicity of this treatment in these patients.
OUTLINE: Patients receive oral perillyl alcohol 4 times a day for 4 weeks. Patients continue treatment in the absence of severe toxicity and disease progression. Patients are followed every 3 months for survival after disease progression.
PROJECTED ACCRUAL: This study will accrue 20-40 patients in approximately 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003238
|United States, Illinois|
|Leonard C. Ferguson Cancer Center|
|Freeport, Illinois, United States, 61032|
|United States, Wisconsin|
|Green Bay Oncology, Ltd.|
|Green Bay, Wisconsin, United States, 54307-3453|
|Mercy Health System|
|Janesville, Wisconsin, United States, 53545|
|Gundersen Lutheran Medical Center|
|La Crosse, Wisconsin, United States, 54601|
|Madison, Wisconsin, United States, 53715|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792|
|Sinai Samaritan Medical Center - Milwaukee|
|Milwaukee, Wisconsin, United States, 53201-0342|
|North Central Oncology Associates, S.C.|
|Wausau, Wisconsin, United States, 54401|
|Study Chair:||George Wilding, MD||University of Wisconsin, Madison|