Perillyl Alcohol in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
NCT ID: NCT00003238
Last Updated: 2019-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
1998-02-28
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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perillyl alcohol
Eligibility Criteria
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Inclusion Criteria
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
120 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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George Wilding, MD
Role: STUDY_CHAIR
University of Wisconsin, Madison
Locations
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Leonard C. Ferguson Cancer Center
Freeport, Illinois, United States
Green Bay Oncology, Ltd.
Green Bay, Wisconsin, United States
Mercy Health System
Janesville, Wisconsin, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
Meriter Hospital
Madison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Sinai Samaritan Medical Center - Milwaukee
Milwaukee, Wisconsin, United States
North Central Oncology Associates, S.C.
Wausau, Wisconsin, United States
Countries
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Other Identifiers
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WCCC-CO-9685
Identifier Type: -
Identifier Source: secondary_id
NCI-T97-0067
Identifier Type: -
Identifier Source: secondary_id
CDR0000066113
Identifier Type: -
Identifier Source: org_study_id