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Trastuzumab and Docetaxel in Treating Patients Who Have Metastatic Prostate Cancer That Is Refractory to Hormone Therapy Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Trastuzumab and Docetaxel in Treating Patients Who Have Metastatic Prostate Cancer That Is Refractory to Hormone Therapy conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Trastuzumab and Docetaxel in Treating Patients Who Have Metastatic Prostate Cancer That Is Refractory to Hormone Therapy Clinical research trials and Trastuzumab and Docetaxel in Treating Patients Who Have Metastatic Prostate Cancer That Is Refractory to Hormone Therapy health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Trastuzumab and Docetaxel in Treating Patients Who Have Metastatic Prostate Cancer That Is Refractory to Hormone Therapy. Trastuzumab and Docetaxel in Treating Patients Who Have Metastatic Prostate Cancer That Is Refractory to Hormone Therapy Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Trastuzumab and Docetaxel in Treating Patients Who Have Metastatic Prostate Cancer That Is Refractory to Hormone Therapy clinical trial. Subjects frequently get the best healthcare possible for their Trastuzumab and Docetaxel in Treating Patients Who Have Metastatic Prostate Cancer That Is Refractory to Hormone Therapy condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Trastuzumab and Docetaxel in Treating Patients Who Have Metastatic Prostate Cancer That Is Refractory to Hormone Therapy  Trastuzumab and Docetaxel in Treating Patients Who Have Metastatic Prostate Cancer That Is Refractory to Hormone Therapy
Trastuzumab and Docetaxel in Treating Patients Who Have Metastatic Prostate Cancer That Is Refractory to Hormone Therapy
For Condition: recurrent prostate cancer,stage 4 prostate cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Beckman Research Institute
Synopsis: RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to compare the effectiveness of trastuzumab alone and in combination with docetaxel in treating patients who have metastatic prostate cancer that is refractory to hormone therapy.
Details: OBJECTIVES: I. Compare the efficacy and toxicity of docetaxel (arm I) vs trastuzumab (Herceptin) (arm II), followed by a combination of docetaxel and trastuzumab in patients with androgen-independent or hormone-refractory metastatic, Her2/neu-positive prostate cancer. (Arm I closed to accrual effective 07/30/2001.) PROTOCOL OUTLINE: This is a multicenter study. Arm I: Patients receive docetaxel IV over 1 hour weekly for 6 weeks. Treatment continues every 8 weeks for at least 2 courses in the absence of unacceptable toxicity. (Arm I closed to accrual effective 07/30/2001. Arm I patients crossover to arm II.) Arm II: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes weekly for 8 weeks. Treatment continues every 8 weeks for at least 2 courses in the absence of unacceptable toxicity. Patients with progressive or stable disease after 2 courses of single-agent therapy receive docetaxel IV over 1 hour on day 1 of each week for 6 consecutive weeks and trastuzumab IV over 30-90 minutes on day 1 of each week for 8 consecutive weeks. Treatment continues every 8 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with complete or partial response to single-agent therapy continue on that therapy until experiencing progressive or stable disease. The patients then proceed to combination therapy. Patients are followed until death. PROJECTED ACCRUAL: A total of 108-160 patients (54-80 per treatment arm) will be accrued for this study. (Arm I closed to accrual effective 07/30/2001.)
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed stage IV prostate cancer (any T, any N, M1, any G; D3) - Clinical evidence of metastatic disease in bone or soft tissue - Her2/neu-positive (2+ and 3+) by immunochemistry or fluorescent in situ hybridization - Androgen-independent: Serum PSA at least 10 ng/mL that has risen on 3 successive evaluations after prior hormonal therapy; At least 1 month since prior antiandrogen therapy (e.g., flutamide, bicalutamide, or nilutamide) and rising PSA levels with 1 of the 2 rising PSA levels, measured at least 2 weeks apart, after antiandrogen withdrawal - Bone only disease and elevated PSA alone allowed - LHRH analog therapy must continue in patients who have not had prior orchiectomy and have castrate levels of testosterone --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent biologic therapy - Chemotherapy: No more than one prior nonanthracycline chemotherapy regimen (including suramin) - Endocrine therapy: See Disease Characteristics; No concurrent corticosteroids as antiemetic - Radiotherapy: At least 4 weeks since prior radiotherapy; At least 3 months since prior strontium chloride Sr 89 and recovered; No concurrent radiotherapy to measurable lesions - Surgery: See Disease Characteristics --Patient Characteristics-- - Age: 18 and over - Performance status: SWOG 0-2 - Life expectancy: At least 12 weeks - Hematopoietic: WBC at least 3,500/mm3; Absolute granulocyte count at least 1,800/mm3; Platelet count at least lower limit of normal (LLN) - Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN); SGOT no greater than 2 times ULN - Renal: Creatinine no greater than 1.6 mg/dL; Creatinine clearance at least 50 mL/min - Cardiovascular: Ejection fraction more than 50% or more than LLN by MUGA scan or 2-D echocardiogram; No symptomatic coronary artery disease; No active ischemia on EKG - Other: Fertile patients must use effective contraception; No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PrimoLara, Study Chair, Beckman Research Institute
University of California Davis Cancer Center
Sacramento, California, 95817
United States
St. Elizabeth's Medical Center of Boston
Brighton, Massachusetts, 02135
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000
United States
Additional Information:
Study ID Numbers: CDR0000067884; CHNMC-PHII-19,CHNMC-IRB-99118,NCI-T98-0090
Study Start Date: August 2000
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005857
Other Recurrent Prostate Cancer Studies:
1. Combination Chemotherapy Plus Warfarin in Treating Patients With Prostate Cancer
2. Chemotherapy, Hormone Therapy, and Radiation Therapy in Treating Patients with Locally Advanced Prostate Cancer
3. Zoledronate in Preventing Bone Loss Caused By Long-Term Androgen Deprivation Therapy in Patients With Stage III or Stage IV Prostate Cancer
4. Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer
5. Genistein in Treating Patients With Stage II, Stage III, or Stage IV Prostate Cancer
Related Studies:
Other recurrent prostate cancer Clinical Trials
Other California Clinical Trials
Other Sacramento Clinical Trials
Trastuzumab and Docetaxel in Treating Patients Who Have Metastatic Prostate Cancer That Is Refractory to Hormone Therapy
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