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Docetaxel in Treating Patients Who Have Undergone Surgery for Prostate Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Docetaxel in Treating Patients Who Have Undergone Surgery for Prostate Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Docetaxel in Treating Patients Who Have Undergone Surgery for Prostate Cancer Clinical research trials and Docetaxel in Treating Patients Who Have Undergone Surgery for Prostate Cancer healthcare trials occur in a lot of 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 does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Docetaxel in Treating Patients Who Have Undergone Surgery for Prostate Cancer. Docetaxel in Treating Patients Who Have Undergone Surgery for Prostate Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Docetaxel in Treating Patients Who Have Undergone Surgery for Prostate Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Docetaxel in Treating Patients Who Have Undergone Surgery for Prostate Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Docetaxel in Treating Patients Who Have Undergone Surgery for Prostate Cancer  Docetaxel in Treating Patients Who Have Undergone Surgery for Prostate Cancer
Docetaxel in Treating Patients Who Have Undergone Surgery for Prostate Cancer
For Condition: stage 2 prostate cancer,stage 1 prostate cancer,stage 3 prostate cancer,adenocarcinoma of the prostate
Status: Recruiting
Sponsor(s): Aventis Pharmaceuticals , 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. Docetaxel may kill any remaining tumor cells following surgery. PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients who have undergone surgery for prostate cancer.
Details: OBJECTIVES: - Determine, preliminarily, the efficacy of docetaxel, in terms of progression-free and 3-year survival rate, in patients with adenocarcinoma of the prostate at high risk of relapse after radical prostatectomy. - Determine the time to disease progression in patients treated with this drug. - Determine the safety and tolerability of this drug in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 3 years. PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate* NOTE: *All other variants are excluded - No evidence of metastatic prostate cancer by bone scan and chest x-ray - Prior prostatectomy within the past 4-8 weeks required - Prostate-specific antigen value obtained within 6 months prior to prostatectomy - High risk of disease progression - Weighted risk of recurrence greater than 2.84 PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic - Bilirubin no greater than upper limit of normal (ULN) - AST/ALT no greater than 1.5 times ULN if alkaline phosphatase no greater than ULN OR - Alkaline phosphatase no greater than 4 times ULN if AST and ALT no greater than ULN - No acute hepatitis Renal - Creatinine less than 1.5 times ULN - No uncontrolled hypercalcemia Cardiovascular - No uncontrolled cardiac arrhythmias - No uncontrolled angina - No uncompensated congestive heart failure - No superior vena cava syndrome Other - Fertile patients must use effective contraception during and for 1 year after study - No other prior malignancy except adequately treated nonmelanoma skin cancer or a curatively treated malignancy (including superficial bladder cancer) without evidence of disease for the past 5 years - No peripheral neuropathy greater than grade 1 - No other unstable medical condition - No active infection - No gastrointestinal bleeding - No uncontrolled diabetes - No dementia - No seizures - No psychological, familial, sociological, or geographical condition or other circumstance that would preclude study completion or follow-up - No history of hypersensitivity to products containing polysorbate 80 PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent anticancer biologic therapy Chemotherapy - No prior systemic chemotherapy for prostate cancer - No other concurrent systemic anticancer chemotherapy Endocrine therapy - No prior systemic hormonal therapy for prostate cancer - No concurrent corticosteroids (except inhaled or topical corticosteroids) - No concurrent systemic anticancer hormonal therapy - No concurrent dehydroepiandrosterone (DHEA) Radiotherapy - No prior radiotherapy - No radiotherapy during and for at least 30 days after study Surgery - See Disease Characteristics Other - No other prior systemic anticancer therapy - No prior enrollment into this study - No other concurrent alternative therapies including the following: - Saw palmetto - Lycopene - PC-SPES (all types) - No other concurrent anticancer therapy - No other concurrent systemic therapy
Total Enrollment:
Location and Contact Information:
Aventis Pharmaceuticals, Incorporated *Recruiting*
Bridgewater, New Jersey, 08807-2854
United States
Recruiting Aventis Oncology 800-798-7425
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Mario Eisenberger 410-614-3511
Additional Information:
Study ID Numbers: CDR0000270750; RPCI-DS-0212,AVENTIS-XRP6976J/2501
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054509
Other Stage 2 Prostate Cancer Studies:
1. Hormone Therapy Plus Radiation Therapy in Treating Patients With Prostate Cancer
2. Hormone Therapy With or Without Mitoxantrone and Prednisone in Treating Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer
3. Radiation Therapy in Treating Patients With Stage I or Stage II Prostate Cancer
4. Low-Fat Diet and/or Flaxseed in Preventing Prostate Cancer
5. Radiation Therapy Compared With No Further Treatment Following Surgery in Treating Patients With Prostate Cancer
Related Studies:
Other stage 2 prostate cancer Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Docetaxel in Treating Patients Who Have Undergone Surgery for Prostate Cancer
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