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Docetaxel, Estramustine, and Exisulind in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Docetaxel, Estramustine, and Exisulind in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Docetaxel, Estramustine, and Exisulind in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy Clinical research trials and Docetaxel, Estramustine, and Exisulind in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Docetaxel, Estramustine, and Exisulind in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy. Docetaxel, Estramustine, and Exisulind in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Docetaxel, Estramustine, and Exisulind in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy clinical trial. Test subjects typically receive the most expert healthcare available for their Docetaxel, Estramustine, and Exisulind in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Docetaxel, Estramustine, and Exisulind in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy Docetaxel, Estramustine, and Exisulind in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Docetaxel, Estramustine, and Exisulind in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
For Condition: adenocarcinoma of the prostate,recurrent prostate cancer,stage 4 prostate cancer
Status: No longer recruiting
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Estramustine may fight prostate cancer by reducing the production of androgens. Exisulind may stop the growth of prostate cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining these therapies may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining estramustine with exisulind and docetaxel in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
Details: OBJECTIVES: - Determine the time to objective and biochemical progression and response proportion (objective and post-therapy changes in PSA) in patients with hormone refractory metastatic prostate cancer treated with docetaxel, estramustine, and exisulind. - Determine the toxic effects of this regimen in these patients. - Determine the overall survival of patients treated with this regimen. OUTLINE: Patients receive oral estramustine 3 times daily on days 1-5, docetaxel IV over 1 hour on day 2, and oral exisulind twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate - Progressive systemic (metastatic) disease despite castrate levels of testosterone secondary to orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist therapy - Castrate levels of testosterone must be maintained - LHRH analog therapy should be continued - Failed prior standard androgen-deprivation therapy - Serum testosterone no greater than 50 ng/mL for patients who have not had bilateral orchiectomy - Evidence of metastatic disease on CT scan, MRI, or bone scan (no positron-emission tomography or prostascint) - Evidence of progressive disease after most recent prior therapy (including hormonal therapy) as defined by 1 of the following: - Measurable disease progression - More than 20% increase in the sum of the longest diameters of target lesions from the time of maximal regression or the appearance of 1 or more new lesions - Bone scan progression - Appearance of 1 or more new lesions on bone scan attributable to prostate cancer AND - PSA at least 5 ng/mL - PSA progression - PSA at least 5 ng/mL which has increased serially from baseline on 2 occasions (at least 1 week apart) NOTE: If the confirmatory PSA is less than screening PSA, an additional test for rising PSA is required PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - AST and ALT no greater than 1.5 times upper limit of normal (ULN) - Bilirubin no greater than ULN Renal - Creatinine no greater than 1.5 times ULN Cardiovascular - No myocardial infarction within the past year - No significant change in anginal pattern within the past year - No congestive heart failure - No New York Heart Association class II-IV heart disease - No deep vein thrombosis within the past year Pulmonary - No pulmonary embolus within the past year Other - No clinically significant peripheral neuropathy - No known hypersensitivity to sulindac - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior cytotoxic chemotherapy (including estramustine or suramin) - No other concurrent chemotherapy Endocrine therapy - See Disease Characteristics - At least 4 weeks since prior flutamide and megestrol - At least 6 weeks since prior bicalutamide and nilutamide - At least 4 weeks since prior hormonal therapy known to decrease PSA levels (including ketoconazole, aminoglutethimide, finasteride, or any systemic corticosteroid) - Concurrent primary testicular androgen suppression therapy (e.g., with a LHRH analog) allowed - No other concurrent hormonal therapy except: - Steroids for adrenal insufficiency - Hormones for non-disease-related conditions (e.g., insulin for diabetes) - Intermittent dexamethasone as an antiemetic Radiotherapy - At least 4 weeks since prior radiotherapy and recovered - At least 8 weeks since prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium - No concurrent palliative radiotherapy Surgery - See Disease Characteristics - At least 4 weeks since prior major surgery and recovered Other - At least 4 weeks since prior herbal product known to decrease PSA levels (including saw palmetto, PC-SPES) - More than 1 week since prior sulindac - No concurrent sulindac - No concurrent chronic nonsteroidal anti-inflammatory drugs (including COX-2 inhibitors and salicylates such as aspirin, mesalamine, salsalate, and sulfasalazine) - Concurrent ibuprofen and naproxen allowed - Low-dose aspirin (e.g., 81 mg/day) for cardiovascular prevention allowed - No concurrent full-dose oral or parenteral anticoagulation therapy - Concurrent bisphosphonate therapy allowed provided therapy was initiated at least 4 weeks before study and disease has progressed despite therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NancyDawson, Study Chair, University of Maryland Greenebaum Cancer Center
Florida Hospital Cancer Institute
Orlando, Florida, 32804
United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
United States
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood, Florida, 33021
United States
Veterans Affairs Medical Center - San Diego
San Diego, California, 92161
United States
Baptist Hospital East - Louisville
Louisville, Kentucky, 40207
United States
Vermont Cancer Center at University of Vermont
Burlington, Vermont, 05401-3498
United States
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Martha Jefferson Hospital
Charlottesville, Virginia, 22902
United States
Lenoir Memorial Hospital Cancer Center
Kinston, North Carolina, 28503-1678
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, 21201
United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612-7323
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Elmhurst Hospital Center
Elmhurst, New York, 11373
United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94115
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, 58102
United States
Veterans Affairs Medical Center - Dallas
Dallas, Texas, 75216
United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, 20422
United States
Lifespan: The Miriam Hospital
Providence, Rhode Island, 02906
United States
Green Mountain Oncology Group
Bennington, Vermont, 05201
United States
St. Mary's Medical Center
Huntington, West Virginia, 25701
United States
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, , 00936-5067
Puerto Rico
Northeast Alabama Regional Medical Center
Anniston, Alabama, 36207
United States
Norris Cotton Cancer Center at Dartmouth Medical School
Lebanon, New Hampshire, 03756-0002
United States
New York Weill Cornell Cancer Center at Cornell University
New York City, New York, 10021
United States
NorthEast Oncology Associates
Concord, North Carolina, 28025
United States
Palm Beach Cancer Institute
West Palm Beach, Florida, 33401
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, 28805
United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, 28374
United States
Cooper University Hospital
Camden, New Jersey, 08103
United States
Saint Anthony Medical Center
Rockford, Illinois, 61108
United States
Missouri Baptist Cancer Center
St. Louis, Missouri, 63131
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
United States
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dalas
Dallas, Texas, 75235-9154
United States
Ministry Medical Group - Northern Region
Rhinelander, Wisconsin, 54501
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Lombardi Cancer Center of Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
New Hanover Regional Medical Center
Wilmington, North Carolina, 28402-9025
United States
West Suburban Center for Cancer Care
River Forest, Illinois, 60305
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Cape Fear Valley Health System
Fayetteville, North Carolina, 28302-2000
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, 49085
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1009
United States
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, 23502
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
United States
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, 89106
United States
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432
United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Ft. Wayne, Indiana, 46885-5099
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, 65203
United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, 24014
United States
Broward General Medical Center
Ft. Lauderdale, Florida, 33316
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
McGill University
Montreal, Quebec, H2W 1S6
Canada
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Additional Information:
Study ID Numbers: CDR0000258766; CALGB-90004
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052845
Other Recurrent Prostate Cancer Studies:
1. Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer
2. BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
3. Hormone Therapy in Treating Patients With Advanced Prostate Cancer
4. Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer
5. Toremifene Followed by Radical Prostatectomy in Treating Patients With Stage I or Stage II Prostate Cancer
Related Studies:
Other recurrent prostate cancer Clinical Trials
Other Florida Clinical Trials
Other West Palm Beach Clinical Trials
Docetaxel, Estramustine, and Exisulind in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
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