Docetaxel, Estramustine, and Exisulind in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
NCT ID: NCT00052845
Last Updated: 2016-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2002-11-30
2009-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Estramustine, Docetaxel, and Carboplatin in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
NCT00005627
Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Local Treatment
NCT00165399
Estramustine, Docetaxel, and Carboplatin for Patients With Hormone Refractory Prostate Cancer Progressing After Mitoxantrone-Based Chemotherapy.
NCT00183924
S9916, Combination Therapy in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy
NCT00004001
Doxorubicin Plus Estramustine in Treating Patients With Metastatic Prostate Cancer
NCT00002721
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Combined chemotherapy
combination of 3 chemotherapy agents for hormone refractory prostate cancer
docetaxel
70 mg/sq m IV infusion over 1 hour Day 2 of ea cycle
estramustine phosphate sodium
280 mg PO tid Days 1-5 of ea cycle
exisulind
Two 125 mg capsules PO bid Days 1-21 of ea cycle
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
docetaxel
70 mg/sq m IV infusion over 1 hour Day 2 of ea cycle
estramustine phosphate sodium
280 mg PO tid Days 1-5 of ea cycle
exisulind
Two 125 mg capsules PO bid Days 1-21 of ea cycle
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nancy Dawson, MD
Role: STUDY_CHAIR
University of Maryland Greenbaum Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Northeast Alabama Regional Medical Center
Anniston, Alabama, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles, California, United States
Veterans Affairs Medical Center - San Diego
San Diego, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
Lombardi Cancer Center of Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, United States
Broward General Medical Center
Fort Lauderdale, Florida, United States
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States
West Suburban Center for Cancer Care
River Forest, Illinois, United States
Saint Anthony Medical Center
Rockford, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Baptist Hospital East - Louisville
Louisville, Kentucky, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, United States
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Missouri Baptist Cancer Center
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, United States
Norris Cotton Cancer Center at Dartmouth Medical School
Lebanon, New Hampshire, United States
Cooper University Hospital
Camden, New Jersey, United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States
Elmhurst Hospital Center
Elmhurst, New York, United States
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States
Mount Sinai Medical Center, NY
New York, New York, United States
State University of New York - Upstate Medical University
Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
NorthEast Oncology Associates
Concord, North Carolina, United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Cape Fear Valley Health System
Fayetteville, North Carolina, United States
Lenoir Memorial Hospital Cancer Center
Kinston, North Carolina, United States
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, United States
New Hanover Regional Medical Center
Wilmington, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Lifespan: The Miriam Hospital
Providence, Rhode Island, United States
Veterans Affairs Medical Center - Dallas
Dallas, Texas, United States
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dalas
Dallas, Texas, United States
Green Mountain Oncology Group
Bennington, Vermont, United States
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, United States
Martha Jefferson Hospital
Charlottesville, Virginia, United States
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, United States
St. Mary's Medical Center
Huntington, West Virginia, United States
Ministry Medical Group - Northern Region
Rhinelander, Wisconsin, United States
McGill University
Montreal, Quebec, Canada
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, Puerto Rico, Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Dawson NA, Halabi S, Ou SS, Biggs DD, Kessinger A, Vogelzang N, Clamon GH, Nanus DM, Kelly WK, Small EJ; Cancer And Leukemia Group B. A phase II study of estramustine, docetaxel, and exisulind in patients with hormone- refractory prostate cancer: results of cancer and leukemia group B trial 90004. Clin Genitourin Cancer. 2008 Sep;6(2):110-6. doi: 10.3816/CGC.2008.n.017.
Dawson NA, Halabi S, Biggs DD, et al.: A phase II study of estramustine (E), docetaxel (D) and exisulind in hormone-refractory prostate cancer (HRPC): toxicity results of CALGB 90004. [Abstract] American Society of Clinical Oncology 2005 Prostate Cancer Symposium, 17-19 February 2005, Orlando, Florida. A-289, 2005.
Dawson NA, Halabi S, Biggs DD, et al.: A phase II Study of estramustine (E), docetaxel (D) and exisulind in hormone-refractory prostate cancer (HRPC): initial results of CALGB 90004 . [Abstract] J Clin Oncol 23 (Suppl 16): A-4649, 415s, 2005.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CALGB-90004
Identifier Type: -
Identifier Source: secondary_id
CDR0000258766
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-90004
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.