Perillyl Alcohol in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
|ClinicalTrials.gov Identifier: NCT00003238|
Recruitment Status : Completed
First Posted : July 21, 2004
Last Update Posted : August 19, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: perillyl alcohol||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|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|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|