Docetaxel, Estramustine, and Exisulind in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Prostate Cancer

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer
Eligibility 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
Sites / Locations
- Northeast Alabama Regional Medical Center
- Rebecca and John Moores UCSD Cancer Center
- Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
- Veterans Affairs Medical Center - San Diego
- UCSF Comprehensive Cancer Center
- Veterans Affairs Medical Center - San Francisco
- CCOP - Christiana Care Health Services
- Lombardi Cancer Center of Georgetown University Medical Center
- Walter Reed Army Medical Center
- Veterans Affairs Medical Center - Washington, DC
- Broward General Medical Center
- Memorial Regional Hospital Comprehensive Cancer Center
- CCOP - Mount Sinai Medical Center
- Florida Hospital Cancer Institute
- Palm Beach Cancer Institute
- MBCCOP - University of Illinois at Chicago
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
- University of Chicago Cancer Research Center
- Louis A. Weiss Memorial Hospital
- West Suburban Center for Cancer Care
- Saint Anthony Medical Center
- Fort Wayne Medical Oncology and Hematology, Incorporated
- CCOP - Northern Indiana CR Consortium
- Holden Comprehensive Cancer Center at University of Iowa
- Baptist Hospital East - Louisville
- Marlene and Stewart Greenebaum Cancer Center, University of Maryland
- Veterans Affairs Medical Center - Baltimore
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- University of Massachusetts Memorial Medical Center - University Campus
- Lakeland Medical Center - St. Joseph
- Veterans Affairs Medical Center - Minneapolis
- University of Minnesota Cancer Center
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
- Ellis Fischel Cancer Center at University of Missouri - Columbia
- Barnes-Jewish Hospital
- Missouri Baptist Cancer Center
- University of Nebraska Medical Center
- CCOP - Southern Nevada Cancer Research Foundation
- Veterans Affairs Medical Center - Las Vegas
- Norris Cotton Cancer Center at Dartmouth Medical School
- Cooper University Hospital
- Veterans Affairs Medical Center - Buffalo
- Elmhurst Hospital Center
- Queens Cancer Center of Queens Hospital
- CCOP - North Shore University Hospital
- North Shore University Hospital
- Memorial Sloan-Kettering Cancer Center
- New York Weill Cornell Cancer Center at Cornell University
- Mount Sinai Medical Center, NY
- State University of New York - Upstate Medical University
- Veterans Affairs Medical Center - Syracuse
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
- Veterans Affairs Medical Center - Asheville
- Lineberger Comprehensive Cancer Center, UNC
- NorthEast Oncology Associates
- Veterans Affairs Medical Center - Durham
- Duke Comprehensive Cancer Center
- Cape Fear Valley Health System
- Lenoir Memorial Hospital Cancer Center
- FirstHealth Moore Regional Hospital
- New Hanover Regional Medical Center
- CCOP - Southeast Cancer Control Consortium
- Comprehensive Cancer Center at Wake Forest University
- Veterans Affairs Medical Center - Fargo
- Arthur G. James Cancer Hospital - Ohio State University
- Western Pennsylvania Hospital
- Lifespan: The Miriam Hospital
- Veterans Affairs Medical Center - Dallas
- Simmons Cancer Center at University of Texas Southwestern Medical Center - Dalas
- Green Mountain Oncology Group
- Vermont Cancer Center at University of Vermont
- Veterans Affairs Medical Center - White River Junction
- Martha Jefferson Hospital
- Virginia Oncology Associates - Norfolk
- MBCCOP - Massey Cancer Center
- Oncology and Hematology Associates of Southwest Virginia, Inc.
- St. Mary's Medical Center
- Ministry Medical Group - Northern Region
- McGill University
- University of Puerto Rico School of Medicine Medical Sciences Campus
Arms of the Study
Arm 1
Experimental
Combined chemotherapy
combination of 3 chemotherapy agents for hormone refractory prostate cancer