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Chemotherapy and Hormone Therapy in Treating Patients With Prostate Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Chemotherapy and Hormone Therapy in Treating Patients With Prostate Cancer conditions. Clinical Trials Search.org is a website committed 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 health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, 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 permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Chemotherapy and Hormone Therapy in Treating Patients With Prostate Cancer clinical trial. Human subjects often get the best healthcare possible for their Chemotherapy and Hormone Therapy in Treating Patients With Prostate Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting 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 Adenocarcinoma Of The Prostate Studies:
1. SU5416 Plus Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
2. Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer
3. Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer
4. Antineoplaston Therapy in Treating Patients With Metastatic Prostate Cancer
5. Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer
Related Studies:
Other adenocarcinoma of the prostate Clinical Trials
Other Massachusetts Clinical Trials
Other Worcester Clinical Trials
Chemotherapy and Hormone Therapy in Treating Patients With Prostate Cancer
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