A Phase III Randomized Trial for Evaluating Second Line Hormonal Therapy (Ketoconazole/Hydrocortisone) Versus Paclitaxel/Estramustine Combination Chemotherapy on Progression Free Survival in Asymptomatic Patients With a Rising PSA After Hormonal Therapy for Prostate Cancer
OBJECTIVES:
- Compare time to objective progression in patients with prostate cancer and a rising
prostate-specific antigen (PSA) after androgen suppression when treated with
second-line hormonal therapy (ketoconazole and hydrocortisone) vs combination
chemotherapy (docetaxel and estramustine).
- Compare time to PSA progression and correlate this with time to objective progression
in patients treated with these regimens.
- Compare the quality of life in patients treated with these regimens.
- Compare overall survival of patients treated with these regimens.
- Compare the natural history of progression in patients treated with these regimens.
- Identify prognostic indicators of clinical outcome by immunohistochemical evaluation of
apoptopic biomarkers in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior
treatment with bisphosphonates (yes vs no). Patients are randomized to 1 of 2 treatment
arms.
- Arm I: Patients receive oral ketoconazole three times daily and oral hydrocortisone
twice daily. Treatment continues in the absence of disease progression or unacceptable
toxicity.
- Arm II: Patients receive oral estramustine three times daily on days 1-5 and docetaxel
IV over 1 hour on day 2. Treatment repeats every 3 weeks for up to 6 courses in the
absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, on day 1 of week 9, at 6 months and 1 year, and
then annually for up to 10 years or until beginning of first non-protocol therapy.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually for 5 years.
PROJECTED ACCRUAL: A total of 590 patients (295 per treatment arm) will be accrued for this
study within 4 years.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Michael A. Carducci, MD
Study Chair
Sidney Kimmel Comprehensive Cancer Center
United States: Food and Drug Administration
CDR0000069088
NCT00027859
May 2003
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
MBCCOP - Hawaii | Honolulu, Hawaii 96813 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis, Indiana 46202 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
Boulder Community Hospital | Boulder, Colorado 80301-9019 |
Penrose Cancer Center at Penrose Hospital | Colorado Springs, Colorado 80933 |
Porter Adventist Hospital | Denver, Colorado 80210 |
Presbyterian - St. Luke's Medical Center | Denver, Colorado 80218 |
St. Joseph Hospital | Denver, Colorado 80218 |
Swedish Medical Center | Englewood, Colorado 80110 |
Sky Ridge Medical Center | Lone Tree, Colorado 80124 |
Hope Cancer Care Center at Longmont United Hospital | Longmont, Colorado 80502 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York, New York 10016 |
Veterans Affairs Outpatient Clinic - Martinez | Martinez, California 94553 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
Veterans Affairs Medical Center - Lexington | Lexington, Kentucky 40511-1093 |
CCOP - Columbus | Columbus, Ohio 43206 |
Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |
Harrington Cancer Center | Amarillo, Texas 79106 |
Martha Jefferson Hospital | Charlottesville, Virginia 22901 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
MBCCOP - University of New Mexico HSC | Albuquerque, New Mexico 87131 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus, Ohio 43210-1240 |
CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
Abramson Cancer Center at the University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | Nashville, Tennessee 37232-2516 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay, Wisconsin 54301 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Veterans Affairs Medical Center - Tucson | Tucson, Arizona 85723 |
Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
Veterans Affairs Medical Center - Wichita | Wichita, Kansas 67218 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
Veterans Affairs Medical Center - Shreveport | Shreveport, Louisiana 71130 |
Veterans Affairs Medical Center - Detroit | Detroit, Michigan 48201-1932 |
Veterans Affairs Medical Center - Jackson | Jackson, Mississippi 39216 |
Veterans Affairs Medical Center - Albuquerque | Albuquerque, New Mexico 87108-5138 |
Veterans Affairs Medical Center - Cincinnati | Cincinnati, Ohio 45220-2288 |
Veterans Affairs Medical Center - Portland | Portland, Oregon 97207 |
Veterans Affairs Medical Center - Charleston | Charleston, South Carolina 29401-5799 |
Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio, Texas 78284 |
Veterans Affairs Medical Center - Temple | Temple, Texas 76504 |
Veterans Affairs Medical Center - Salt Lake City | Salt Lake City, Utah 84148 |
Veterans Affairs Medical Center - Seattle | Seattle, Washington 98108 |
Veterans Affairs Medical Center - New Orleans | New Orleans, Louisiana 70112 |
Naval Medical Center - San Diego | San Diego, California 92134-3202 |
Veterans Affairs Medical Center - Syracuse | Syracuse, New York 13210 |
Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
West Suburban Center for Cancer Care | River Forest, Illinois 60305 |
Cape Fear Valley Health System | Fayetteville, North Carolina 28302-2000 |
Veterans Affairs Medical Center - Amarillo | Amarillo, Texas 79106 |
St. Mary's Medical Center | Huntington, West Virginia 25701 |
CCOP - Colorado Cancer Research Program, Incorporated | Denver, Colorado 80224 |
Veterans Affairs Medical Center - Tampa (Haley) | Tampa, Florida 33612 |
Oklahoma University Medical Center | Oklahoma City, Oklahoma 73104 |
CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
Mount Sinai Medical Center | New York, New York 10029 |
Comprehensive Cancer Institute | Huntsville, Alabama 35801 |
Veterans Affairs Medical Center - Little Rock | Little Rock, Arkansas 72205 |
Veterans Affairs Medical Center - Hines | Hines, Illinois 60141 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
New Hampshire Oncology-Hematology, PA - Hooksett | Hooksett, New Hampshire 03106 |
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke | Roanoke, Virginia 24014 |
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | Saint Joseph, Michigan 49085 |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center | Los Angeles, California 90048 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Memorial Regional Cancer Center at Memorial Regional Hospital | Hollywood, Florida 33021 |
St. Mary-Corwin Regional Medical Center | Pueblo, Colorado 81004 |
CCOP - Mayo Clinic Scottsdale Oncology Program | Scottsdale, Arizona 85259 |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa, Florida 33612 |
Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |
Medical Center of Aurora - South Campus | Aurora, Colorado 80012-0000 |
Rocky Mountain Cancer Centers - Denver Rose | Denver, Colorado 80220 |
Rocky Mountain Cancer Centers - Thornton | Thornton, Colorado 80229 |