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Sponsors and Collaborators: |
University of Wisconsin, Madison National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003238 |
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 | Intervention | Phase |
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Prostate Cancer |
Drug: perillyl alcohol |
Phase II |
Study Type: | Interventional |
Study Design: | 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 |
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.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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
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 | |
Gundersen Lutheran Medical Center | |
La Crosse, Wisconsin, United States, 54601 | |
Mercy Health System | |
Janesville, Wisconsin, United States, 53545 | |
University of Wisconsin Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792 | |
North Central Oncology Associates, S.C. | |
Wausau, Wisconsin, United States, 54401 | |
Sinai Samaritan Medical Center - Milwaukee | |
Milwaukee, Wisconsin, United States, 53201-0342 | |
Meriter Hospital | |
Madison, Wisconsin, United States, 53715 |
Study Chair: | George Wilding, MD | University of Wisconsin, Madison |
Study ID Numbers: | CDR0000066113, WCCC-CO-9685, NCI-T97-0067 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003238 History of Changes |
Health Authority: | United States: Federal Government |
recurrent prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Perilla alcohol Perillyl Alcohol Urogenital Neoplasms Genital Diseases, Male |
Hormones Prostatic Neoplasms Recurrence Androgens Ethanol |
Genital Neoplasms, Male Prostatic Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Perilla alcohol Urogenital Neoplasms Enzyme Inhibitors |
Genital Diseases, Male Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Prostatic Neoplasms |