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Chemotherapy and Hormone Therapy in Treating Patients With Prostate Cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Chemotherapy and Hormone Therapy in Treating Patients With Prostate Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Chemotherapy and Hormone Therapy in Treating Patients With Prostate Cancer Clinical research trials and Chemotherapy and Hormone Therapy in Treating Patients With Prostate Cancer healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Chemotherapy and Hormone Therapy in Treating Patients With Prostate Cancer. Chemotherapy and Hormone Therapy in Treating Patients With Prostate Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Chemotherapy and Hormone Therapy in Treating Patients With Prostate Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Chemotherapy and Hormone Therapy in Treating Patients With Prostate Cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Chemotherapy and Hormone Therapy in Treating Patients With Prostate Cancer  Chemotherapy and Hormone Therapy in Treating Patients With Prostate Cancer
Chemotherapy and Hormone Therapy in Treating Patients With Prostate Cancer
For Condition: stage 1 prostate cancer,adenocarcinoma of the prostate
Status: No longer recruiting
Sponsor(s): University of Massachusetts Medical Center ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide and leuprolide may fight prostate cancer by reducing the production of androgens. PURPOSE: Phase II trial to study the effectiveness of chemotherapy consisting of docetaxel and estramustine plus hormone therapy in treating patients who have previously undergone radiation therapy or surgical removal of the prostate for stage I prostate cancer.
Details: OBJECTIVES: - Determine the feasibility of administering docetaxel plus estramustine in combination with androgen deprivation therapy in patients with PSA elevation following radiotherapy or radical prostatectomy for early prostate cancer. - Evaluate this regimen in terms of PSA response rate, response duration, and time to future therapeutic intervention in this patient population. - Evaluate testosterone, free testosterone, and sex hormone binding globulin in relation to this treatment regimen in these patients. OUTLINE: Patients receive oral estramustine three times a day on days 1-5 and docetaxel IV over 1 hour on day 2. Treatment repeats every 3 weeks for 4 courses. Patients receive oral bicalutamide daily beginning on week 12 and leuprolide intramuscularly every 3 months beginning on week 13. Treatment continues for 15 months. Patients are followed every 3 months for 2 years, every 4 months for 1 year, and every 6 months thereafter until disease progression. PROJECTED ACCRUAL: Approximately 55 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate - No metastases - No measurable or evaluable disease - 2 consecutively rising PSA levels at least 2 weeks apart, despite prior radical prostatectomy or radiotherapy (external beam or implant) - PSA risen to twice nadir value post radiotherapy PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - 0-1 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than upper limit of normal (ULN) - Must meet 1 of the following criteria: - SGOT and/or SGPT no greater than 2.5 times ULN AND alkaline phosphatase no greater than ULN - Alkaline phosphatase no greater than 4.0 times ULN AND SGOT and/or SGPT no greater than ULN - SGOT and SGPT no greater than 1.5 times ULN AND alkaline phosphatase no greater than 2.5 times ULN Renal: - Not specified Cardiovascular: - At least 6 months since prior myocardial infarction, angina, or New York Heart Association class III or IV heart disease - No active thrombophlebitis - At least 6 months since prior thromboembolic events including deep vein thrombosis and cerebrovascular accident Other: - No other malignancies within the past 5 years except curatively treated basal cell skin cancer - No active infection - No significant neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior estramustine or suramin Endocrine therapy: - At least 6 months since prior neoadjuvant or adjuvant hormonal therapy of no greater than 6 months duration - No concurrent corticosteroids Radiotherapy: - Salvage radiotherapy post prostatectomy allowed Surgery: - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MaryTaplin, Study Chair, University of Massachusetts Medical Center
Lahey Clinic - Burlington
Burlington, Massachusetts, 01805
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
United States
Additional Information:
Study ID Numbers: CDR0000067095; UMASS-H-3745,NCI-V99-1546
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003915
Other Stage 1 Prostate Cancer Studies:
1. Chemotherapy and Hormone Therapy in Treating Patients With Prostate Cancer
2. BMS-247550 With or Without Estramustine in Treating Patients With Progressive Prostate Cancer
3. Doxercalciferol Before Surgery in Treating Localized Prostate Cancer
4. Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer
5. NCI HIGH PRIORITY CLINICAL TRIAL --- Prostatectomy Compared With Watchful Waiting in Treating Patients With Stage I or Stage II Prostate Cancer
Related Studies:
Other stage 1 prostate cancer Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Chemotherapy and Hormone Therapy in Treating Patients With Prostate Cancer
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