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Combination Therapy in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy 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 Combination Therapy in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Combination Therapy in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy Clinical research trials and Combination Therapy in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy 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 Combination Therapy in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy. Combination Therapy in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy 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 Combination Therapy in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy clinical trial. Test subjects typically receive the most effective healthcare possible for their Combination Therapy in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy 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 > "C" Clinical Trials Conditions > Combination Therapy in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy  Combination Therapy in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy
Combination Therapy in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy
For Condition: stage 4 prostate cancer,adenocarcinoma of the prostate,recurrent prostate cancer
Status: No longer recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI),Cancer and Leukemia Group B,North Central Cancer Treatment Group
Synopsis: RATIONALE: Drugs used in chemotherapy and hormone therapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells. It is not yet known whether estramustine plus docetaxel is more effective than mitoxantrone plus prednisone for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of estramustine plus docetaxel with that of mitoxantrone plus prednisone in treating patients who have stage IV prostate cancer that has not responded to hormone therapy.
Details: OBJECTIVES: - Compare the overall survival and progression-free survival in patients with hormone-refractory, metastatic adenocarcinoma of the prostate treated with docetaxel and estramustine vs mitoxantrone and prednisone. - Compare the qualitative and quantitative toxic effects of these regimens in this patient population. - Compare the quality of life, including palliation of metastatic bone pain and global quality of life, of patients treated with these regimens. - Record prostate-specific antigen values for future correlations with response and survival in patients treated with these regimens. - Compare the responses in patients with bidimensionally measurable disease treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease status (measurable or evaluable disease progression vs rising PSA only), NCI Common Toxicity Criteria version 2.X pain scale (grade 2 or greater vs less than 2), and SWOG performance status (0-1 vs 2-3). Patients are randomized to one of two treatment arms. - Arm I: Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV over 1 hour on day 2. - Arm II: Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21. Treatment in both arms repeats every 3 weeks for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression. Quality of life is assessed at baseline, after courses 4 and 8, and then at 1 year after randomization. Patients are followed every 6 months for 2 years and then annually for 1 year. PROJECTED ACCRUAL: A total of 620 patients (310 per arm) will be accrued for this study within 3.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed metastatic adenocarcinoma of the prostate - Unresponsive or refractory to hormonal therapy, as defined by at least 1 of the following criteria: - Progression of bidimensionally measurable disease - Progression of evaluable but not measurable disease (bone scan) - At least 2 consecutive rises in PSA and a PSA level of at least 5 ng/mL - No minimum PSA required for measurable disease or non-PSA evaluable disease - Soft tissue disease that has been irradiated within the past 2 months is not considered measurable disease - Prior orchiectomy OR - Medical castration using leuprolide or goserelin - LHRH agonist therapy must continue during study - Prior nonsteroidal antiandrogens (flutamide, ketoconazole, bicalutamide, or nilutamide) allowed if disease progression occurred - No third-space fluid accumulation such as ascites or symptomatic pleural effusion - No brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - SWOG 0-3 - Performance status 3 must be due to pain secondary to bone metastases Life expectancy: - Not specified Hematopoietic: - No hypercoagulability Hepatic: - Not specified Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - No history of myocardial infarction - No history of congestive heart failure unless well controlled - No history of cerebrovascular accident or atrial fibrillation - No active thrombophlebitis - LVEF at least 50% by MUGA scan or 2-D echocardiogram Pulmonary: - No history of pulmonary embolus Other: - Recovered from major infections - No other significant active medical illness - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer currently in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior biologic therapy and recovered - No more than 1 prior biologic therapy regimen - No concurrent biological response modifiers Chemotherapy: - At least 4 weeks since prior chemotherapy and recovered - No more than 1 prior chemotherapy regimen - No prior estramustine, taxanes, anthracyclines, or mitoxantrone - No other concurrent chemotherapy Endocrine therapy: - See Disease Characteristics - At least 4 weeks since prior flutamide or ketoconazole (6 weeks for bicalutamide or nilutamide) - No concurrent corticosteroids or hormonal therapy (except megestrol for hot flashes or continuing LHRH treatment) Radiotherapy: - See Disease Characteristics - Prior samarium Sm 153 lexidronam pentasodium allowed - At least 4 weeks since prior radiotherapy and recovered - No prior radiotherapy to 30% or more of bone marrow - No prior strontium chloride Sr 89 - No concurrent radiotherapy Surgery: - See Disease Characteristics - At least 3 weeks since prior surgery and recovered Other: - At least 4 weeks since prior bisphosphonates - No prior anticoagulation therapy (i.e., warfarin), except aspirin - No concurrent bisphosphonates
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DanielPetrylak, Study Chair, Columbia Presbyterian Medical Center
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Altru Health System
Grand Forks, North Dakota, 58201
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
CentraCare Health Plaza
St. Cloud, Minnesota, 56303
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
Medcenter One Health System
Bismark, North Dakota, 58501
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
Additional Information:
Study ID Numbers: CDR0000067211; SWOG-S9916,CLB-99808,NCCTG-S9916,CTSU
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004001
Other Recurrent Prostate Cancer Studies:
1. Radiation Therapy With or Without Bicalutamide in Treating Patients With Stage II, Stage III, or Recurrent Prostate Cancer
2. Zoledronate in Preventing Skeletal (Bone)-Related Events in Patients Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases
3. CT Scans in Guiding the Treatment of Patients With Prostate Cancer Who are Undergoing Radiation Therapy
4. Estramustine, Docetaxel, and Carboplatin in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
5. SU5416 Compared to Dexamethasone in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy
Related Studies:
Other recurrent prostate cancer Clinical Trials
Other North Dakota Clinical Trials
Other Grand Forks Clinical Trials
Combination Therapy in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy
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