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Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer Clinical research trials and Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer. Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer clinical trial. Participants oftentimes recieve the most expert healthcare available for their Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "H" Clinical Trials Conditions > Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer  Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer
Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer
For Condition: stage 3 prostate cancer,stage 4 prostate cancer,adenocarcinoma of the prostate,recurrent prostate cancer,stage 2 prostate cancer
Status: Recruiting
Sponsor(s): Radiation Therapy Oncology Group , National Cancer Institute (NCI),Eastern Cooperative Oncology Group
Synopsis: RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin, leuprolide, flutamide, or bicalutamide may stop the adrenal glands from producing androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells. It is not yet known if chemotherapy given at the same time as hormone therapy is more effective than chemotherapy given after hormone therapy in treating prostate cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of chemotherapy given at the same time as hormone therapy with that of chemotherapy given after hormone therapy in treating patients who have prostate cancer.
Details: OBJECTIVES: - Compare the survival of patients with high-risk hormone-naive prostate cancer treated with androgen blockade with concurrent chemotherapy vs delayed chemotherapy. - Compare biochemical control in patients treated with these regimens. - Determine the toxicity of these regimens in these patients. - Compare the time to clinical failure, as measured by progression on bone scan or CT scan, in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior therapy (surgery vs radiotherapy and/or brachytherapy vs both), original combined Gleason score (7 vs 8-10), and prior vaccine therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms. - Patients receive androgen blockade (AB) comprising leuprolide intramuscularly once every 1-3 months or goserelin subcutaneously once every 1-3 months. Patients also receive oral flutamide or oral bicalutamide once daily for at least 1 month. Within 2 weeks of initiation of AB, patients begin chemotherapy. Patients receive 1 of the following chemotherapy regimens: - Regimen A: Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV on day 3. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. - Regimen B: Patients receive oral estramustine 3 times daily on days 1-5 and paclitaxel IV on day 3 weekly for 6 weeks. Treatment repeats every 8 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. - Regimen C: Patients receive oral ketoconazole 3 times daily on days 1-7, 15-21, and 29-35; doxorubicin IV on days 1, 15, and 29; vinblastine IV on days 8, 22, and 36; and oral estramustine 3 times daily on days 8-14, 22-28, and 36-42. Treatment repeats every 8 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. - Regimen D: Patients receive oral estramustine 3 times daily on days 1-4 and docetaxel IV over 1 hour on day 3 weekly for 3 weeks. Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. - Regimen E: With approval from the protocol chair, patients may receive a regimen that has been demonstrated in a published phase II study to have at least a 50% response rate as measured by PSA decrease from baseline over 2 measurements 4 weeks apart or a decrease in measurable soft tissue disease by 50% in 2 dimensions. - Arm II: Patients receive AB as in arm I. Patients continue with AB until clinical failure, at which time patients receive chemotherapy as in arm I. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1,050 patients will be accrued for this study within 4-6 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of adenocarcinoma of the prostate - Failed local treatments (surgery and/or radiotherapy and/or brachytherapy) as defined by rising PSA of at least 2.0 ng/mL (confirmed by 2 measurements at least 2 weeks apart) and a doubling time of 8 months or less - No clinical or radiographic evidence of disease - Original Gleason score of at least 7 - No metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Zubrod 0-1 Life expectancy: - Not specified Hematopoietic: - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL - No history of bleeding disorders that would contraindicate warfarin, including clotting factor defects Hepatic: - Bilirubin no greater than 1.5 mg/dL - AST/ALT no greater than 1.5 times upper limit of normal Renal: - Creatinine no greater than 1.5 mg/dL - BUN no greater than 1.2 times normal Cardiovascular: - No symptomatic heart disease - No history of myocardial infarction - No history of thromboembolic events (e.g., deep vein thrombosis, symptomatic cerebrovascular events, or pulmonary embolism) Other: - No other major medical or psychiatric illness that would preclude study entry - No other prior or concurrent invasive malignancy within the past 5 years except nonmelanoma skin cancer - No history of esophageal varices - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 6 weeks since prior vaccine therapy Chemotherapy: - At least 5 years since prior chemotherapy Endocrine therapy: - Prior adjuvant or neoadjuvant hormonal therapy of less than 8 months duration allowed - At least 1 year since prior androgen therapy Radiotherapy: - See Disease Characteristics - At least 5 years since prior radiotherapy to sites other than prostate Surgery: - See Disease Characteristics Other: - Concurrent warfarin allowed - Concurrent bisphosphonate therapy initiated prior to or after randomization allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NaomiBalzer-Haas, Study Chair, Fox Chase Cancer Center
Gulf Coast Cancer Treatment Center *Recruiting*
Panama City, Florida, 32405-4587
United States
Recruiting R. Nichols 850-763-0036
John Stoddard Cancer Center at Iowa Methodist Medical Center *Recruiting*
Des Moines, Iowa, 50309
United States
Recruiting Roscoe Morton 515-241-4245
Memorial Hospital Cancer Center *Recruiting*
Colorado Springs, Colorado, 80909
United States
Recruiting Mark Hazuka 719-365-5800
West Michigan Cancer Center *Recruiting*
Kalamazoo, Michigan, 49007
United States
Recruiting Contact Person 616-373-7488
Iowa Lutheran Hospital *Recruiting*
Des Moines, Iowa, 50316-2301
United States
Recruiting Roscoe Morton 515-663-5612
University of Texas Medical Branch *Recruiting*
Galveston, Texas, 77555-0209
United States
Recruiting Ivan Kessel 409-772-2531
St. Mary-Corwin Regional Medical Center *Recruiting*
Pueblo, Colorado, 81004
United States
Recruiting Marlow Sloan 719-560-6000
Akron General Medical Center *Recruiting*
Akron, Ohio, 44302
United States
Recruiting Mitchell Fromm 330-296-5019
Sky Ridge Medical Center *Recruiting*
Lone Tree, Colorado, 80124
United States
Recruiting Dennis Carter 720-225-4211
Tallahassee Memorial Hospital *Recruiting*
Tallahassee, Florida, 32308
United States
Recruiting Timothy Bolek 850-431-5255
Instituto de Enfermedades Neoplasicas *Recruiting*
Lima, , 34
Peru
Recruiting Carlos Vallejos-Sologuren 51-14-499-137
San Juan City Hospital *Recruiting*
San Juan, , 00936-7344
Puerto Rico
Recruiting Luis Baez-Diaz 787-641-3693
University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor, Michigan, 48109-0010
United States
Recruiting Howard Sandler 734-936-9338
Mercy Fitzgerald Hospital *Recruiting*
Darby, Pennsylvania, 19023
United States
Recruiting Leslie Tupchong 610-237-4370
Swedish Medical Center *Recruiting*
Englewood, Colorado, 80110
United States
Recruiting Marshall Davis 303-788-5860
Boulder Community Hospital *Recruiting*
Boulder, Colorado, 80301-9019
United States
Recruiting John Fleagle 303-440-2399
Westmead Hospital *Recruiting*
Westmead, New South Wales, 2145
Australia
Recruiting Richard Kefford 61-2-9845-6033
Longmont United Hospital *Recruiting*
Longmont, Colorado, 80501
United States
Recruiting Robert Fisher 303-485-4132
Saint Alphonsus Regional Medical Center *Recruiting*
Boise, Idaho, 83706
United States
Recruiting Contact Person 208-367-3131
Rocky Mountain Cancer Centers *Recruiting*
Thornton, Colorado, 80260
United States
Recruiting Alvin Otsuka 303-386-7622
Rocky Mountain Cancer Centers - Rose *Recruiting*
Denver, Colorado, 80220
United States
Recruiting Scot Sedlacek 303-321-0302
Erlanger Health Systems *Recruiting*
Chattanooga, Tennessee, 37403
United States
Recruiting Contact Person 423-778-7623
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111
United States
Recruiting Naomi Balzer-Haas 215-728-2974
CCOP - Greenville *Recruiting*
Greenville, South Carolina, 29615
United States
Recruiting Michael Zurenko 864-241-6251
Utah Valley Regional Medical Center - Provo *Recruiting*
Provo, Utah, 84604
United States
Recruiting Tarlton Blair 801-373-7850 ext. 2480
Wendt Regional Cancer Center of Finley Hospital *Recruiting*
Dubuque, Iowa, 52001
United States
Recruiting Thomas Lally 319-589-2468
CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay, Wisconsin, 54307-3453
United States
Recruiting Gerald Bayer 920-433-8889
Cancer Care Center, Incorporated *Recruiting*
Salem, Ohio, 44460
United States
Recruiting Contact Person 330-375-3557
University of Miami Sylvester Cancer Center *Recruiting*
Miami, Florida, 33136
United States
Recruiting Arnold Markoe 305-243-4319
Penn State Cancer Institute at Milton S. Hershey Medical Center *Recruiting*
Hershey, Pennsylvania, 17033-0850
United States
Recruiting Witold Rybka 717-531-1050
All Saints Cancer Center at All Saints Healthcare *Recruiting*
Racine, Wisconsin, 53405
United States
Recruiting James Taylor 262-687-5000
St. Joseph Hospital *Recruiting*
Denver, Colorado, 80218-1191
United States
Recruiting Michael McLaughlin 303-861-3302
McKay-Dee Hospital Center *Recruiting*
Ogden, Utah, 84403
United States
Recruiting Contact Person 801-627-2800
Mercy Cancer Center at Mercy Medical Center-Des Moines *Recruiting*
Des Moines, Iowa, 50314
United States
Recruiting Roscoe Morton 515-247-3121
MBCCOP - University of New Mexico HSC *Recruiting*
Albuquerque, New Mexico, 87131
United States
Recruiting Cynthia Cathcart 505-272-5688
Dixie Regional Medical Center *Recruiting*
St. George, Utah, 84770
United States
Recruiting Ray Richards 801-688-4175
Cancer Treatment Center *Recruiting*
Wooster, Ohio, 44691
United States
Recruiting Contact Person 330-262-6060
CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem, North Carolina, 27104-4241
United States
Recruiting James Atkins 336-777-3036
Rapid City Regional Hospital *Recruiting*
Rapid City, South Dakota, 57709
United States
Recruiting Daniel Petereit 605-719-2360
Cottonwood Hospital Medical Center *Recruiting*
Murray, Utah, 84107
United States
Recruiting Contact Person 801-314-5300
Shands Cancer Center at the University of Florida Health Science Center *Recruiting*
Gainesville, Florida, 32610-0385
United States
Recruiting William Mendenhall 352-265-0287
Mercy Hospital Cancer Center - Scranton *Recruiting*
Scranton, Pennsylvania, 18501
United States
Recruiting Harmar Brereton 570-348-7200
Presbyterian-St Luke's Medical Center *Recruiting*
Denver, Colorado, 80218
United States
Recruiting Robert Jotte 303-388-4876
Foundation for Cancer Research and Education *Recruiting*
Phoenix, Arizona, 85013
United States
Recruiting David Brachman 602-274-4484
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
Medical Center of Aurora - South Campus *Recruiting*
Aurora, Colorado, 80012-0000
United States
Recruiting Sami Diab 303-418-7600
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-5671
United States
Recruiting A.J. Cmelak 615-322-2555
Porter Adventist Hospital *Recruiting*
Denver, Colorado, 80210
United States
Recruiting David Trevarthen 303-788-8675
Akron City Hospital *Recruiting*
Akron, Ohio, 44304
United States
Recruiting William Demas 330-375-3557
University Cancer Center at University of Washington Medical Center *Recruiting*
Seattle, Washington, 98195-6043
United States
Recruiting David Schwartz 206-768-5356
Cancer Research for the Ozarks *Recruiting*
Springfield, Missouri, 65807
United States
Recruiting J. Dover 417-889-5671
Penrose Cancer Center *Recruiting*
Colorado Springs, Colorado, 80933
United States
Recruiting Robert Sayre 719-577-2555
Midlands Cancer Center at Midlands Community Hospital *Recruiting*
Papillion, Nebraska, 68128-4157
United States
Recruiting James Mailliard 402-593-3000
CCOP - Colorado Cancer Research Program, Incorporated *Recruiting*
Denver, Colorado, 80224
United States
Recruiting Eduardo Pajon 303-777-2663
Additional Information:
Study ID Numbers: CDR0000069186; RTOG-DEV-1028,RTOG-P-0014,CTSU,ECOG-RTOG-P-0014
Study Start Date:
Record last reviewed: November 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030654
Other Stage 2 Prostate Cancer Studies:
1. Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic Prostate Cancer
2. Hormone Therapy Followed By Internal Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer
3. Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer
4. Hydrocortisone Plus Aminoglutethimide or Ketoconazole in Treating Patients With Localized Stage IV Prostate Cancer
5. Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer
Related Studies:
Other stage 2 prostate cancer Clinical Trials
Other Michigan Clinical Trials
Other Ann Arbor Clinical Trials
Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer
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