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.

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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.

View Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

80

Study ID:

NCT00052845

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 74 Locations for this study

See Locations Near You

Northeast Alabama Regional Medical Center
Anniston Alabama, 36207, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla California, 92093, United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles California, 90048, United States
Veterans Affairs Medical Center - San Diego
San Diego California, 92161, United States
UCSF Comprehensive Cancer Center
San Francisco California, 94115, United States
Veterans Affairs Medical Center - San Francisco
San Francisco California, 94121, United States
CCOP - Christiana Care Health Services
Newark Delaware, 19713, United States
Lombardi Cancer Center of Georgetown University Medical Center
Washington District of Columbia, 20007, United States
Walter Reed Army Medical Center
Washington District of Columbia, 20307, United States
Veterans Affairs Medical Center - Washington, DC
Washington District of Columbia, 20422, United States
Broward General Medical Center
Fort Lauderdale Florida, 33316, United States
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood Florida, 33021, United States
CCOP - Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
Florida Hospital Cancer Institute
Orlando Florida, 32804, United States
Palm Beach Cancer Institute
West Palm Beach Florida, 33401, United States
MBCCOP - University of Illinois at Chicago
Chicago Illinois, 60612, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago Illinois, 60612, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
Louis A. Weiss Memorial Hospital
Chicago Illinois, 60640, United States
West Suburban Center for Cancer Care
River Forest Illinois, 60305, United States
Saint Anthony Medical Center
Rockford Illinois, 61108, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne Indiana, 46885, United States
CCOP - Northern Indiana CR Consortium
South Bend Indiana, 46601, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City Iowa, 52242, United States
Baptist Hospital East - Louisville
Louisville Kentucky, 40207, 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
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester Massachusetts, 01655, United States
Lakeland Medical Center - St. Joseph
Saint Joseph Michigan, 49085, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis Minnesota, 55417, United States
University of Minnesota Cancer Center
Minneapolis Minnesota, 55455, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia Missouri, 65201, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia Missouri, 65203, United States
Barnes-Jewish Hospital
Saint Louis Missouri, 63110, United States
Missouri Baptist Cancer Center
Saint Louis Missouri, 63131, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas Nevada, 89106, United States
Veterans Affairs Medical Center - Las Vegas
Las Vegas Nevada, 89106, United States
Norris Cotton Cancer Center at Dartmouth Medical School
Lebanon New Hampshire, 03756, United States
Cooper University Hospital
Camden New Jersey, 08103, United States
Veterans Affairs Medical Center - Buffalo
Buffalo New York, 14215, United States
Elmhurst Hospital Center
Elmhurst New York, 11373, United States
Queens Cancer Center of Queens Hospital
Jamaica New York, 11432, United States
CCOP - North Shore University Hospital
Manhasset New York, 11030, United States
North Shore University Hospital
Manhasset New York, 11030, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
New York Weill Cornell Cancer Center at Cornell University
New York New York, 10021, United States
Mount Sinai Medical Center, NY
New York New York, 10029, United States
State University of New York - Upstate Medical University
Syracuse New York, 13210, United States
Veterans Affairs Medical Center - Syracuse
Syracuse New York, 13210, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse New York, 13217, United States
Veterans Affairs Medical Center - Asheville
Asheville North Carolina, 28805, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill North Carolina, 27599, United States
NorthEast Oncology Associates
Concord North Carolina, 28025, United States
Veterans Affairs Medical Center - Durham
Durham North Carolina, 27705, United States
Duke Comprehensive Cancer Center
Durham North Carolina, 27710, United States
Cape Fear Valley Health System
Fayetteville North Carolina, 28302, United States
Lenoir Memorial Hospital Cancer Center
Kinston North Carolina, 28503, United States
FirstHealth Moore Regional Hospital
Pinehurst North Carolina, 28374, United States
New Hanover Regional Medical Center
Wilmington North Carolina, 28402, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem North Carolina, 27104, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem North Carolina, 27157, United States
Veterans Affairs Medical Center - Fargo
Fargo North Dakota, 58102, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus Ohio, 43210, United States
Western Pennsylvania Hospital
Pittsburgh Pennsylvania, 15224, United States
Lifespan: The Miriam Hospital
Providence Rhode Island, 02906, United States
Veterans Affairs Medical Center - Dallas
Dallas Texas, 75216, United States
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dalas
Dallas Texas, 75235, United States
Green Mountain Oncology Group
Bennington Vermont, 05201, United States
Vermont Cancer Center at University of Vermont
Burlington Vermont, 05401, United States
Veterans Affairs Medical Center - White River Junction
White River Junction Vermont, 05009, United States
Martha Jefferson Hospital
Charlottesville Virginia, 22902, United States
Virginia Oncology Associates - Norfolk
Norfolk Virginia, 23502, United States
MBCCOP - Massey Cancer Center
Richmond Virginia, 23298, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke Virginia, 24014, United States
St. Mary's Medical Center
Huntington West Virginia, 25701, United States
Ministry Medical Group - Northern Region
Rhinelander Wisconsin, 54501, United States
McGill University
Montreal Quebec, H2W 1, Canada
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan , 00936, Puerto Rico

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

80

Study ID:

NCT00052845

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

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