A Phase II Study Of Estramustine, Docetaxel, And Exisulind (IND #64733) In Men With Hormone Refractory Prostate Cancer
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.
PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 18 months.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to progression
24 months from study entry
No
Nancy A. Dawson, MD
Study Chair
University of Maryland Greenebaum Cancer Center
United States: Food and Drug Administration
CDR0000258766
NCT00052845
November 2002
April 2009
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
CCOP - North Shore University Hospital | Manhasset, New York 11030 |
State University of New York - Upstate Medical University | Syracuse, New York 13210 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
MBCCOP - Massey Cancer Center | Richmond, Virginia 23298-0037 |
Mount Sinai Medical Center, NY | New York, New York 10029 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |
Green Mountain Oncology Group | Rutland, Vermont 05701 |
Veterans Affairs Medical Center - White River Junction | White River Junction, Vermont 05009 |
Martha Jefferson Hospital | Charlottesville, Virginia 22901 |
MBCCOP - University of Illinois at Chicago | Chicago, Illinois 60612 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
North Shore University Hospital | Manhasset, New York 11030 |
Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago, Illinois 60612 |
Veterans Affairs Medical Center - San Francisco | San Francisco, California 94121 |
Baptist Hospital East - Louisville | Louisville, Kentucky 40207 |
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
Veterans Affairs Medical Center - Fargo | Fargo, North Dakota 58102 |
Oncology and Hematology Associates of Southwest Virginia, Inc. | Roanoke, Virginia 24014 |
Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia, Missouri 65201 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Veterans Affairs Medical Center - Buffalo | Buffalo, New York 14215 |
Veterans Affairs Medical Center - Syracuse | Syracuse, New York 13210 |
Veterans Affairs Medical Center - Durham | Durham, North Carolina 27705 |
Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
Broward General Medical Center | Fort Lauderdale, Florida 33316 |
Florida Hospital Cancer Institute | Orlando, Florida 32804 |
Marlene and Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201-1595 |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
University of Massachusetts Memorial Medical Center - University Campus | Worcester, Massachusetts 01655 |
Northeast Alabama Regional Medical Center | Anniston, Alabama 36207 |
Veterans Affairs Medical Center - San Diego | San Diego, California 92161 |
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
Veterans Affairs Medical Center - Washington, DC | Washington, District of Columbia 20422 |
Memorial Regional Hospital Comprehensive Cancer Center | Hollywood, Florida 33021 |
Louis A. Weiss Memorial Hospital | Chicago, Illinois 60640 |
West Suburban Center for Cancer Care | River Forest, Illinois 60305 |
Saint Anthony Medical Center | Rockford, Illinois 61108 |
Fort Wayne Medical Oncology and Hematology, Incorporated | Fort Wayne, Indiana 46885-5099 |
Veterans Affairs Medical Center - Baltimore | Baltimore, Maryland 21201 |
Lakeland Medical Center - St. Joseph | Saint Joseph, Michigan 49085 |
Veterans Affairs Medical Center - Las Vegas | Las Vegas, Nevada 89106 |
Cooper University Hospital | Camden, New Jersey 08103 |
Elmhurst Hospital Center | Elmhurst, New York 11373 |
Queens Cancer Center of Queens Hospital | Jamaica, New York 11432 |
Veterans Affairs Medical Center - Asheville | Asheville, North Carolina 28805 |
NorthEast Oncology Associates | Concord, North Carolina 28025 |
Cape Fear Valley Health System | Fayetteville, North Carolina 28302-2000 |
Lenoir Memorial Hospital Cancer Center | Kinston, North Carolina 28503-1678 |
FirstHealth Moore Regional Hospital | Pinehurst, North Carolina 28374 |
New Hanover Regional Medical Center | Wilmington, North Carolina 28402-9025 |
Lifespan: The Miriam Hospital | Providence, Rhode Island 02906 |
Veterans Affairs Medical Center - Dallas | Dallas, Texas 75216 |
Virginia Oncology Associates - Norfolk | Norfolk, Virginia 23502 |
St. Mary's Medical Center | Huntington, West Virginia 25701 |
Ministry Medical Group - Northern Region | Rhinelander, Wisconsin 54501 |
Vermont Cancer Center at University of Vermont | Burlington, Vermont 05405-0075 |
New York Weill Cornell Cancer Center at Cornell University | New York, New York 10021 |
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center | Los Angeles, California 90048 |
Norris Cotton Cancer Center at Dartmouth Medical School | Lebanon, New Hampshire 03756-0002 |
Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |
Palm Beach Cancer Institute | West Palm Beach, Florida 33401 |
Lombardi Cancer Center of Georgetown University Medical Center | Washington, District of Columbia 20007 |
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dalas | Dallas, Texas 75235-9154 |