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Estramustine, Docetaxel, and Carboplatin in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Estramustine, Docetaxel, and Carboplatin in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Estramustine, Docetaxel, and Carboplatin in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy Clinical research trials and Estramustine, Docetaxel, and Carboplatin in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Estramustine, Docetaxel, and Carboplatin in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy. Estramustine, Docetaxel, and Carboplatin in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Estramustine, Docetaxel, and Carboplatin in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy clinical trial. Subjects typically recieve the finest healthcare available for their Estramustine, Docetaxel, and Carboplatin in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Estramustine, Docetaxel, and Carboplatin in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy  Estramustine, Docetaxel, and Carboplatin in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
Estramustine, Docetaxel, and Carboplatin in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
For Condition: adenocarcinoma of the prostate,recurrent prostate cancer
Status: Completed
Sponsor(s): Dana-Farber/Harvard Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of estramustine, docetaxel, and carboplatin in treating patients who have prostate cancer that has not responded to hormonal therapy.
Details: OBJECTIVES: - Determine the maximum tolerated dose of weekly docetaxel when combined with carboplatin and estramustine in patients with hormone refractory prostate cancer. - Determine the safety and efficacy of this regimen in this patient population. OUTLINE: This is a dose escalation study of docetaxel. Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV over 1 hour on day 2 of weeks 1-3. Patients also receive carboplatin IV over 1 hour on day 2 of week 1 only. Treatment continues every 28 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 3-5 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 5 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/85 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate - Disease progression following androgen ablation therapy (hormonal or surgical) by either: - Increase in the product of bidimensional diameters of 1 or more radiographically documented sites of measurable disease OR - Two consecutive increases in PSA documented over a previous reference value - First increase in PSA should occur a minimum of 1 week from the reference value and be confirmed - First PSA value is less than the previous value, then patient is eligible provided next PSA is greater than the second PSA - Testosterone levels documented in the castrate range (i.e., less than 30 ng/mL) PATIENT CHARACTERISTICS: Age: - 18 to 85 Performance status: - CALGB 0-2 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin normal - SGOT no greater than 2.5 times upper limit of normal (ULN) if alkaline phosphatase normal OR - Alkaline phosphatase no greater than 4 times ULN if SGOT normal OR - SGOT no greater than 1.5 times ULN and alkaline phosphatase no greater than 2.5 times ULN Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - No myocardial infarction within past year - No significant change in anginal pattern within past 6 months - No New York Heart Association class II-IV heart disease - No deep venous thrombosis within past year Other: - No significant peripheral neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Prior chemotherapy allowed except taxanes or platinum derivatives Endocrine therapy: - See Disease Characteristics - At least 4 weeks since prior antiandrogens Radiotherapy: - At least 4 weeks since prior radiotherapy Surgery: - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WilliamOh, Study Chair, Dana-Farber/Harvard Cancer Center
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Additional Information:
Study ID Numbers: CDR0000067775; RP-DFCI-98238,DFCI-98238,NCI-G00-1779
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005627
Other Recurrent Prostate Cancer Studies:
1. CT Scans in Guiding the Treatment of Patients With Prostate Cancer Who are Undergoing Radiation Therapy
2. Photodynamic Therapy With Lutetium Texaphyrin in Treating Patients With Locally Recurrent Prostate Cancer
3. Brachytherapy in Treating Patients With Recurrent Prostate Cancer
4. Low, Intermediate, or High Dose Suramin in Treating Patients With Hormone-Refractory Prostate Cancer
5. PET Scan in Treating Patients With Metastatic Prostate Cancer
Related Studies:
Other recurrent prostate cancer Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Estramustine, Docetaxel, and Carboplatin in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
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