Perillyl Alcohol in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Actual Primary Completion Date :||October 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|