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Docetaxel in Treating Patients With Stage II or Stage III Prostate Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Docetaxel in Treating Patients With Stage II or Stage III Prostate Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Docetaxel in Treating Patients With Stage II or Stage III Prostate Cancer Clinical research trials and Docetaxel in Treating Patients With Stage II or Stage III Prostate Cancer healthcare trials happen in many of places across 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 effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Docetaxel in Treating Patients With Stage II or Stage III Prostate Cancer. Docetaxel in Treating Patients With Stage II or Stage III Prostate Cancer Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Docetaxel in Treating Patients With Stage II or Stage III Prostate Cancer clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Docetaxel in Treating Patients With Stage II or Stage III Prostate Cancer condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Docetaxel in Treating Patients With Stage II or Stage III Prostate Cancer Docetaxel in Treating Patients With Stage II or Stage III Prostate Cancer
Docetaxel in Treating Patients With Stage II or Stage III Prostate Cancer
For Condition: stage 3 prostate cancer,stage 2 prostate cancer,adenocarcinoma of the prostate
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Dana-Farber/Harvard Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients who have stage II or stage III prostate cancer.
Details: OBJECTIVES: I. Determine the pathologic complete response rate to docetaxel in patients with high risk stage II or III prostate cancer. II. Determine the toxicity of this treatment in these patients. III. Correlate clinical measures of response (e.g., symptoms, physical exam, serum PSA, and endorectal MRI) with pathologic response to this treatment in these patients. PROTOCOL OUTLINE: Patients receive docetaxel IV over 30 minutes weekly for 4 weeks. Treatment continues for 2-6 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 19-45 patients will be accrued for this study over 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/85 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed adenocarcinoma of the prostate - Potential candidate for radical prostatectomy - Any of the following: Clinical stage T3 patients; Serum PSA at least 20 ng/mL; Gleason score 8-10; Clinical T2 disease and either of the following: MRI evidence of seminal vesicle involvement; Gleason 4+3 cancer with either 5 or 6 biopsies positive --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy for prostate cancer - Endocrine therapy: No prior hormonal therapy for prostate cancer - Radiotherapy: No prior radiotherapy for prostate cancer - Surgery: See Disease Characteristics; No prior surgery for prostate cancer --Patient Characteristics-- - Age: 18 to 85 - Performance status: CALGB 0-1 - Life expectancy: Not specified - Hematopoietic: WBC greater than 3,000/mm3; Hematocrit greater than 30%; Platelet count greater than 100,000/mm3 - Hepatic: SGOT and bilirubin normal - Renal: Not specified - Other: No active infection; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WilliamOh, Study Chair, Dana-Farber/Harvard Cancer Center
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Additional Information:
Study ID Numbers: CDR0000067764; DFCI-99193,NCI-G00-1757
Study Start Date: December 1999
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005096
Other Stage 3 Prostate Cancer Studies:
1. Low-Fat, High-Fiber Diet Compared to a Standard Diet in Treating Patients With Prostate Cancer
2. Radiation Therapy Plus Hormone Therapy Compared With Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer
3. Hormone Therapy Plus Radiation Therapy in Treating Patients With Prostate Cancer
4. Diet and PSA Levels in Patients With Prostate Cancer
5. Vaccine Therapy Plus QS21 in Treating Patients With Progressive Prostate Cancer
Related Studies:
Other stage 3 prostate cancer Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Docetaxel in Treating Patients With Stage II or Stage III Prostate Cancer
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