Prostate Cancer Clinical Trial
Docetaxel, Estramustine, and Exisulind in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Summary
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.
Full Description
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.
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
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There are 74 Locations for this study
Anniston Alabama, 36207, United States
La Jolla California, 92093, United States
Los Angeles California, 90048, United States
San Diego California, 92161, United States
San Francisco California, 94115, United States
San Francisco California, 94121, United States
Newark Delaware, 19713, United States
Washington District of Columbia, 20007, United States
Washington District of Columbia, 20307, United States
Washington District of Columbia, 20422, United States
Fort Lauderdale Florida, 33316, United States
Hollywood Florida, 33021, United States
Miami Beach Florida, 33140, United States
Orlando Florida, 32804, United States
West Palm Beach Florida, 33401, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Chicago Illinois, 60640, United States
River Forest Illinois, 60305, United States
Rockford Illinois, 61108, United States
Fort Wayne Indiana, 46885, United States
South Bend Indiana, 46601, United States
Iowa City Iowa, 52242, United States
Louisville Kentucky, 40207, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21201, United States
Boston Massachusetts, 02115, United States
Worcester Massachusetts, 01655, United States
Saint Joseph Michigan, 49085, United States
Minneapolis Minnesota, 55417, United States
Minneapolis Minnesota, 55455, United States
Columbia Missouri, 65201, United States
Columbia Missouri, 65203, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63131, United States
Omaha Nebraska, 68198, United States
Las Vegas Nevada, 89106, United States
Las Vegas Nevada, 89106, United States
Lebanon New Hampshire, 03756, United States
Camden New Jersey, 08103, United States
Buffalo New York, 14215, United States
Elmhurst New York, 11373, United States
Jamaica New York, 11432, United States
Manhasset New York, 11030, United States
Manhasset New York, 11030, United States
New York New York, 10021, United States
New York New York, 10021, United States
New York New York, 10029, United States
Syracuse New York, 13210, United States
Syracuse New York, 13210, United States
Syracuse New York, 13217, United States
Asheville North Carolina, 28805, United States
Chapel Hill North Carolina, 27599, United States
Concord North Carolina, 28025, United States
Durham North Carolina, 27705, United States
Durham North Carolina, 27710, United States
Fayetteville North Carolina, 28302, United States
Kinston North Carolina, 28503, United States
Pinehurst North Carolina, 28374, United States
Wilmington North Carolina, 28402, United States
Winston-Salem North Carolina, 27104, United States
Winston-Salem North Carolina, 27157, United States
Fargo North Dakota, 58102, United States
Columbus Ohio, 43210, United States
Pittsburgh Pennsylvania, 15224, United States
Providence Rhode Island, 02906, United States
Dallas Texas, 75216, United States
Dallas Texas, 75235, United States
Bennington Vermont, 05201, United States
Burlington Vermont, 05401, United States
White River Junction Vermont, 05009, United States
Charlottesville Virginia, 22902, United States
Norfolk Virginia, 23502, United States
Richmond Virginia, 23298, United States
Roanoke Virginia, 24014, United States
Huntington West Virginia, 25701, United States
Rhinelander Wisconsin, 54501, United States
Montreal Quebec, H2W 1, Canada
San Juan , 00936, Puerto Rico
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