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| Sponsor: | Chao Family Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006101 |
Purpose
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of eflornithine may be an effective way to prevent the development of prostate cancer.
PURPOSE: Randomized phase II trial to determine the effectiveness of eflornithine in preventing prostate cancer in patients who are at high risk of developing the disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: eflornithine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control |
| Official Title: | Randomized Placebo-Controlled, Double-Blind Phase IIb Chemoprevention Trial of Difluoromethylornithine in Brothers and First Cousin Males of Familial Prostate Cancer Probands |
| Study Start Date: | September 2000 |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to age (35 to 60 vs 61 to 70) and presence of localized cancer (yes vs no).
All patients receive oral placebo daily for 4 weeks. Patients who are compliant and take the placebo 5-7 days each week are randomized to one of two arms.
PROJECTED ACCRUAL: A total of 100 patients (50 per arm) will be accrued for this study within 3 years.
Eligibility| Ages Eligible for Study: | 35 Years to 70 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Gastrointestinal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, California | |
| Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center | |
| Orange, California, United States, 92868 | |
| Study Chair: | Anne R. Simoneau, MD | Chao Family Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000068110, UCIRVINE-97-18, UCIRVINE-U01-CA-81886-01, NCI-P00-0164 |
| Study First Received: | August 3, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00006101 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I prostate cancer |
|
Anti-Infective Agents Trypanocidal Agents Antiprotozoal Agents Genital Neoplasms, Male Prostatic Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Urogenital Neoplasms Enzyme Inhibitors |
Genital Diseases, Male Pharmacologic Actions Antiparasitic Agents Neoplasms Neoplasms by Site Eflornithine Therapeutic Uses Prostatic Neoplasms |