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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA031946 | U.S. NIH Grant/Contract | View source | |
| CALGB-90004 | |||
| CDR0000258766 | Registry Identifier | NCI Physician Data Query |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined chemotherapy | Experimental | combination of 3 chemotherapy agents for hormone refractory prostate cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docetaxel | Drug | 70 mg/sq m IV infusion over 1 hour Day 2 of ea cycle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression | 24 months from study entry |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | treatment up to 3 mon post treatment | |
| Changes in PSA | During treatment then q 3 mon until ds progression | |
| Overall Survival |
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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
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
Bone scan progression
PSA progression
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
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:
Radiotherapy
Surgery
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)
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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| Name | Affiliation | Role |
|---|---|---|
| Nancy Dawson, MD | University of Maryland Greenbaum Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northeast Alabama Regional Medical Center | Anniston | Alabama | 36207 | United States | ||
| Rebecca and John Moores UCSD Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18824434 | Result | 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. | |
| Result | 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. | ||
| Result | 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. |
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| estramustine phosphate sodium |
| Drug |
280 mg PO tid Days 1-5 of ea cycle |
|
| exisulind | Drug | Two 125 mg capsules PO bid Days 1-21 of ea cycle |
|
| 24 months from study entry |
| La Jolla |
| California |
| 92093-0658 |
| 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 D.C. | District of Columbia | 20007 | United States |
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307-5000 | United States |
| Veterans Affairs Medical Center - Washington, DC | Washington D.C. | 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 | 60612-7323 | United States |
| Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago | Illinois | 60612 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | 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 | 46885-5099 | United States |
| CCOP - Northern Indiana CR Consortium | South Bend | Indiana | 46601 | United States |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | 52242-1009 | 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 | St Louis | Missouri | 63110 | United States |
| Missouri Baptist Cancer Center | St Louis | Missouri | 63131 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-7680 | 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 | 03756-0002 | 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 | 27599-7295 | 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 | 28302-2000 | United States |
| Lenoir Memorial Hospital Cancer Center | Kinston | North Carolina | 28503-1678 | United States |
| FirstHealth Moore Regional Hospital | Pinehurst | North Carolina | 28374 | United States |
| New Hanover Regional Medical Center | Wilmington | North Carolina | 28402-9025 | United States |
| CCOP - Southeast Cancer Control Consortium | Winston-Salem | North Carolina | 27104-4241 | United States |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina | 27157-1082 | United States |
| Veterans Affairs Medical Center - Fargo | Fargo | North Dakota | 58102 | United States |
| Arthur G. James Cancer Hospital - Ohio State University | Columbus | Ohio | 43210-1240 | 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 | 75235-9154 | United States |
| Green Mountain Oncology Group | Bennington | Vermont | 05201 | United States |
| Vermont Cancer Center at University of Vermont | Burlington | Vermont | 05401-3498 | 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 | 23298-0037 | 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 1S6 | Canada |
| University of Puerto Rico School of Medicine Medical Sciences Campus | San Juan | Puerto Rico | 00936-5067 | Puerto Rico |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D004961 | Estramustine |
| C025463 | sulindac sulfone |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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