- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003238
Perillyl Alcohol in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
A Phase II Trial of Perillyl Alcohol (NSC 641066) Administered Daily In Patients With Metastatic Androgen Independent Prostate Cancer
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 Overview
Detailed Description
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
Phase
- Phase 2
Contacts and Locations
Study Locations
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Illinois
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Freeport, Illinois, United States, 61032
- Leonard C. Ferguson Cancer Center
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Wisconsin
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Green Bay, Wisconsin, United States, 54307-3453
- Green Bay Oncology, Ltd.
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Janesville, Wisconsin, United States, 53545
- Mercy Health System
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La Crosse, Wisconsin, United States, 54601
- Gundersen Lutheran Medical Center
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Madison, Wisconsin, United States, 53792
- University of Wisconsin Comprehensive Cancer Center
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Madison, Wisconsin, United States, 53715
- Meriter Hospital
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Milwaukee, Wisconsin, United States, 53201-0342
- Sinai Samaritan Medical Center - Milwaukee
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Wausau, Wisconsin, United States, 54401
- North Central Oncology Associates, S.C.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Histologically confirmed progressive metastatic or progressive regional nodal adenocarcinoma of the prostate Regression of tumor following hormone therapy If on antiandrogen therapy, must fail to respond to withdrawal or have progressive disease following withdrawal of antiandrogen No CNS disease
PATIENT CHARACTERISTICS: Age: Not specified Performance status: WCCC 0-2 Life expectancy: At least 3 months Hematopoietic: WBC at least 3000/mm3 Absolute neutrophil count at least 1200/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2.5 times normal Renal: Creatinine no greater than 1.5 times upper limit of normal Other: At least 5 years since prior malignancy other than: Inactive nonmelanoma skin cancer Adequately treated stage I or II cancer in complete remission No other serious illness No spinal cord compression symptoms
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy required Endocrine therapy: Failed one secondary hormonal manipulation for metastatic disease Concurrent testicular androgen suppression (LHRH) allowed No concurrent hormonal therapy other than LHRH agonist At least 4 weeks since antiandrogen treatment in order to evaluate for response withdrawal Radiotherapy: At least 4 weeks since prior radiation therapy No prior strontium therapy Surgery: No prior orchiectomy Other: No concurrent cholesterol lowering agents No concurrent supplemental vitamins No concurrent antioxidants
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000066113
- R03CA073906 (U.S. NIH Grant/Contract)
- WCCC-CO-9685
- NCI-T97-0067
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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