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Genistein in Treating Patients With Stage II, Stage III, or Stage IV Prostate Cancer Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Genistein in Treating Patients With Stage II, Stage III, or Stage IV Prostate Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Genistein in Treating Patients With Stage II, Stage III, or Stage IV Prostate Cancer Clinical research trials and Genistein in Treating Patients With Stage II, Stage III, or Stage IV Prostate Cancer healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Genistein in Treating Patients With Stage II, Stage III, or Stage IV Prostate Cancer. Genistein in Treating Patients With Stage II, Stage III, or Stage IV Prostate Cancer Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Genistein in Treating Patients With Stage II, Stage III, or Stage IV Prostate Cancer clinical trial. Subjects frequently obtain the most expert healthcare possible for their Genistein in Treating Patients With Stage II, Stage III, or Stage IV Prostate Cancer condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "G" Clinical Trials Conditions > Genistein in Treating Patients With Stage II, Stage III, or Stage IV Prostate Cancer  Genistein in Treating Patients With Stage II, Stage III, or Stage IV Prostate Cancer
Genistein in Treating Patients With Stage II, Stage III, or Stage IV Prostate Cancer
For Condition: stage 3 prostate cancer,stage 4 prostate cancer,adenocarcinoma of the prostate,stage 2 prostate cancer,recurrent prostate cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , UNC Lineberger Comprehensive Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Randomized phase I trial to determine the effectiveness of genistein in treating patients who have stage II, stage III, or stage IV prostate cancer.
Details: OBJECTIVES: I. Determine the safety and pharmacokinetics of genistein in patients with stage II, III, or IV prostate cancer. PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral genistein twice daily. Arm II: Patients receive oral placebo twice daily. Treatment continues for 3 months in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 6 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 40 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed stage B, C, or D adenocarcinoma of the prostate not amenable to surgery --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: Not specified - Endocrine therapy: At least 3 months since prior hormonal therapy OR No concurrent estrogen; Other concurrent hormonal therapy allowed if stable regimen for more than 3 months - Radiotherapy: At least 4 weeks since prior radiotherapy and recovered - Surgery: See Disease Characteristics; At least 3 weeks since prior surgery and recovered - Other: At least 6 weeks since prior antibiotics; No concurrent genotoxicity therapy --Patient Characteristics-- - Age: 40 and over - Performance status: ECOG 0-2 - Life expectancy: At least 6 months - Hematopoietic: WBC at least 3,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 2.0 mg/dL; Transaminases less than 4 times upper limit of normal - Renal: Creatinine less than 2.0 mg/dL - Cardiovascular: No New York Heart Association class III or IV heart disease - Other: No significant abnormalities of internal organs, neurologic status, or biochemical levels; No history of seizures; No concurrent serious illness; No acute infection requiring antibiotic therapy except chronic urinary tract infection; No other prior or concurrent malignancy within the past 2 years except nonmelanoma carcinoma of the skin; No history of substance abuse or addiction; No alcohol intake greater than 2 drinks/day or 14 drinks/week; No diet containing more than 20 mg of genistein/day; No known soy intolerance; No prior breast cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LeAnneTyndall, Study Chair, UNC Lineberger Comprehensive Cancer Center
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Additional Information:
Study ID Numbers: CDR0000067840; UNC-LCCC-9711,UNC-GCRC-1203,NCI-G00-1788
Study Start Date: December 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005827
Other Adenocarcinoma Of The Prostate Studies:
1. CT Scans in Guiding the Treatment of Patients With Prostate Cancer Who are Undergoing Radiation Therapy
2. External-Beam Radiation Therapy Plus Implanted Radiation Therapy in Treating Patients With Prostate Cancer
3. Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
4. Brachytherapy in Treating Patients With Recurrent Prostate Cancer
5. Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer
Related Studies:
Other adenocarcinoma of the prostate Clinical Trials
Other North Carolina Clinical Trials
Other Chapel Hill Clinical Trials
Genistein in Treating Patients With Stage II, Stage III, or Stage IV Prostate Cancer
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