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Eflornithine in Treating Patients At High Risk of Developing Prostate Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Eflornithine in Treating Patients At High Risk of Developing Prostate Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Eflornithine in Treating Patients At High Risk of Developing Prostate Cancer Clinical research trials and Eflornithine in Treating Patients At High Risk of Developing Prostate Cancer medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Eflornithine in Treating Patients At High Risk of Developing Prostate Cancer. Eflornithine in Treating Patients At High Risk of Developing Prostate Cancer Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Eflornithine in Treating Patients At High Risk of Developing Prostate Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their Eflornithine in Treating Patients At High Risk of Developing Prostate Cancer condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Eflornithine in Treating Patients At High Risk of Developing Prostate Cancer  Eflornithine in Treating Patients At High Risk of Developing Prostate Cancer
Eflornithine in Treating Patients At High Risk of Developing Prostate Cancer
For Condition: stage 1 prostate cancer
Status: Recruiting
Sponsor(s): Chao Family Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: 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: Randomizedphase II trial to determine the effectiveness of eflornithine in preventing prostate cancer in patients who are at high risk of developing the disease.
Details: OBJECTIVES: - Compare the levels of polyamines (putrescine, spermidine, and spermine) and progression-related genes in the prostate tissue of patients at high genetic risk for prostate cancer treated with eflornithine (DFMO) vs placebo. - Determine the side effects of DFMO and compare them with the biological effect on the prostate gland in these patients. 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. - Arm I: Patients receive oral placebo daily. - Arm II: Patients receive high-dose oral eflornithine (DFMO) daily. Treatment continues for 1 year in the absence of unacceptable toxicity. PROJECTED ACCRUAL: A total of 100 patients (50 per arm) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 35 Years/70 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Unaffected brother or first-degree cousin of a young (under age 70) prostate cancer proband with a family history (two or more first-degree relatives) of prostate cancer - No prior non-localized prostate cancer or previously diagnosed premalignant prostate disease PATIENT CHARACTERISTICS: Age: - 35 to 70 Performance status: - SWOG 0-1 OR - Karnofsky 70-100% Life expectancy: - At least 5 years Hematopoietic: - Hematocrit at least 35% - WBC at least 4,000/mm^3 with normal differential - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin less than 2.0 mg/dL - SGOT or SGPT less than 2 times normal Renal: - Creatinine less than 1.5 mg/dL - Less than 1+ protein, 0-3 casts, and 0-5 WBCs and RBCs in urine Gastrointestinal: - No medically mandated special diet that would preclude compliance with study participation - No documented or symptomatic gastric or duodenal ulcer disease within the past year Other: - No severe metabolic disorders or other life-threatening acute or chronic disease - No other invasive cancer within the past 5 years except nonmelanoma skin cancer - No predisposition to difficulties with wound healing or repair PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No concurrent chemotherapy Endocrine therapy: - At least 3 months since prior finasteride Radiotherapy: - No prior radiotherapy to pelvic area - No concurrent x-rays Surgery: - Not specified Other: - At least 3 months since prior chemoprevention agents - No aspirin or aspirin-containing products within 10 days prior to each study biopsy - No concurrent anticoagulants
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ThomasAhlering, Study Chair, Chao Family Comprehensive Cancer Center
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center *Recruiting*
Orange, California, 92868
United States
Recruiting Thomas Ahlering 714-456-8200
Additional Information:
Study ID Numbers: CDR0000068110; UCIRVINE-97-18,NCI-P00-0164,UCIRVINE-U01-CA-81886-01
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006101
Other Stage 1 Prostate Cancer Studies:
1. Magnetic Resonance Imaging and Magnetic Resonance Spectroscopic Imaging in Diagnosing the Extent of Disease in Patients With Prostate Cancer
2. Broxuridine Plus Surgery in Treating Patients With Stage I or Stage II Prostate Cancer
3. Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer
4. NCI HIGH PRIORITY CLINICAL TRIAL --- Prostatectomy Compared With Watchful Waiting in Treating Patients With Stage I or Stage II Prostate Cancer
5. Doxercalciferol Before Surgery in Treating Localized Prostate Cancer
Related Studies:
Other stage 1 prostate cancer Clinical Trials
Other California Clinical Trials
Other Orange Clinical Trials
Eflornithine in Treating Patients At High Risk of Developing Prostate Cancer
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