Study Of Epoetin Alfa Vs Epoetin Alfa With Dexamethasone In Hormone Refractory Prostate Cancer Patients: Impact On Fatigue, Anemia, Functional Status And Quality Of Life
OBJECTIVES:
- Compare the effect of epoetin alfa with or without dexamethasone on the level of
cancer-related fatigue measured by the FACIT fatigue subscale, in patients with
hormone-refractory prostate cancer.
- Compare the effect of these regimens on increasing hemoglobin levels in these patients.
- Compare the effect of these regimens on palliation of other disease-related symptoms
and on functional status and overall quality of life of these patients.
- Compare the survival rate of these regimens in these patients.
- Compare the toxicity profile of these regimens in these patients.
- Determine the incidence of adrenal suppression in these patients after receiving
dexamethasone therapy.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to usual
fatigue severity on the Brief Fatigue Inventory numerical scale (3-6 vs 7-10) and hemoglobin
level (8-10 g/dL vs 10.1-11.9 g/dL). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive epoetin alfa subcutaneously once a week.
- Arm II: Patients receive epoetin alfa as in arm I and oral dexamethasone once a day.
In both arms, treatment continues for 12 weeks in the absence of unacceptable toxicity.
Quality of life and fatigue are assessed at baseline and then at 4, 8, and 12 weeks.
Patients are followed for 3 years.
PROJECTED ACCRUAL: A total of 282 patients (141 per treatment arm) will be accrued for this
study within approximately 3 years.
Interventional
Allocation: Randomized, Primary Purpose: Supportive Care
Fatigue response as measured by the Functional Assessment of Chronic Illness Therapy Fatigue Subscale
Shirley S. Hwang, RN, MS
Study Chair
Veterans Affairs Medical Center - East Orange
United States: Federal Government
CDR0000301881
NCT00060398
June 2004
Name | Location |
---|---|
CCOP - Wichita | Wichita, Kansas 67214-3882 |
Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
Aurora Presbyterian Hospital | Aurora, Colorado 80012 |
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 |
Rose Medical Center | Denver, Colorado 80220 |
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 |
North Suburban Medical Center | Thornton, Colorado 80229 |
Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
Joliet Oncology-Hematology Associates, Limited - West | Joliet, Illinois 60435 |
Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Foote Hospital | Jackson, Michigan 49201 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
Seton Cancer Institute - Saginaw | Saginaw, Michigan 48601 |
St. John Macomb Hospital | Warren, Michigan 48093 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
CCOP - Duluth | Duluth, Minnesota 55805 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
CCOP - MeritCare Hospital | Fargo, North Dakota 58122 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre, Pennsylvania 18711 |
Medical X-Ray Center, PC | Sioux Falls, South Dakota 57105 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
CCOP - Columbus | Columbus, Ohio 43206 |
Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Veterans Affairs Medical Center - Lakeside Chicago | Chicago, Illinois 60611 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
CCOP - Colorado Cancer Research Program, Incorporated | Denver, Colorado 80224 |
Tufts - New England Medical Center | Boston, Massachusetts 02111 |
Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls, South Dakota 57117-5134 |
Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx, New York 10461 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
Aultman Hospital Cancer Center at Aultman Health Foundation | Canton, Ohio 44710-1799 |
St. Mary's - Duluth Clinic Cancer Center | Duluth, Minnesota 55805 |
Our Lady of Mercy Medical Center Comprehensive Cancer Center | Bronx, New York 10466 |
St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
Cancer Center of Kansas, P.A. - El Dorado | El Dorado, Kansas 67042 |
Southwest Medical Center | Liberal, Kansas 67901 |
Cancer Center of Kansas, P.A. - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, P.A. - Wichita | Wichita, Kansas 67214 |
Fox Chase Virtua Health Cancer Program - Marlton | Marlton, New Jersey 08053 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Doctors Hospital at Ohio Health | Columbus, Ohio 43228 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Grant Riverside Cancer Services | Columbus, Ohio 43215 |
Mount Carmel West Hospital | Columbus, Ohio 43222 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio 45750 |
Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio 43055 |
Community Hospital of Springfield and Clark County | Springfield, Ohio 45505 |
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital | Westerville, Ohio 43081 |
Genesis - Good Samaritan Hospital | Zanesville, Ohio 43701 |
CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Voorhees, New Jersey 08043 |
University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
Memorial Medical Center Cancer Services | Modesto, California 95355 |
St. Mary-Corwin Regional Medical Center | Pueblo, Colorado 81004 |
Swedish Covenant Hospital | Chicago, Illinois 60625 |
Mercy Hospital and Medical Center | Chicago, Illinois 60616 |
Hematology and Oncology Associates | Chicago, Illinois 60611 |
Midwest Center for Hematology/Oncology | Joliet, Illinois 60432 |
North Shore Oncology and Hematology Associates, Limited - Libertyville | Libertyville, Illinois 60048 |
Northwest Medical Specialist, PC | Niles, Illinois 60714 |
Midwest Cancer Research Group, Incorporated | Skokie, Illinois 60077 |
Hematology/Oncology of the North Shore at Gross Point Medical Center | Skokie, Illinois 60076 |
McFarland Clinic, P. C. | Ames, Iowa 50010 |
John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Mercy Capitol Hospital | Des Moines, Iowa 50307 |
Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates - West Des Moines | West Des Moines, Iowa 50266 |
Cancer Center of Kansas, P.A. - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Cancer Center of Kansas, P.A. - Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas, P.A. - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, P.A. - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas, P.A. - Salina | Salina, Kansas 67042 |
Cancer Center of Kansas, P.A. - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, P.A. - Medical Arts Tower | Wichita, Kansas 67208 |
Associates in Womens Health, P.A. - North Review | Wichita, Kansas 67203 |
Cancer Center of Kansas, P.A. - Winfield | Winfield, Kansas 67156 |
Pennington Cancer Center at Baton Rouge General | Baton Rouge, Louisiana 70806 |
Mary Bird Perkins Cancer Center - Baton Rouge | Baton Rouge, Louisiana 70809 |
Medical Center of Louisiana - New Orleans | New Orleans, Louisiana 70112 |
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital | Ann Arbor, Michigan 48106-0995 |
MeritCare Clinic - Bemidji | Bemidji, Minnesota 56601 |
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Hubert H. Humphrey Cancer Center at North Memorial Medical Center | Robbinsdale, Minnesota 55422-2900 |
Park Nicollet Health Services | St. Louis Park, Minnesota 55416 |
MeritCare Medical Group | Fargo, North Dakota 58122 |
Mercy Medical Center | Springfield, Ohio 45504 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Green Bay Oncology, Limited at St. Vincent Hospital | Green Bay, Wisconsin 54301-3526 |
Dean Medical Center - Fish Hatchery | Madison, Wisconsin 53715 |
Holy Family Memorial Medical Center Cancer Care Center | Manitowoc, Wisconsin 54221-1450 |
St. Anthony's Memorial Hospital | Effingham, Illinois 62401 |
Miller-Dwan Medical Center | Duluth, Minnesota 55805 |
Geisinger Medical Group | State College, Pennsylvania 16801 |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa, Florida 33612 |
MBCCOP - Meharry Medical College - Nashville | Nashville, Tennessee 37208-3599 |
Shore Memorial Hospital - Somers Point | Somers Point, New Jersey 08244 |
Elmhurst Memorial Hospital | Elmhurst, Illinois 60126 |
Lawrence Memorial Hospital of Medford | Medford, Massachusetts 02155 |
Commonwealth Hematology-Oncology P. C. - Quincy | Quincy, Massachusetts 02169 |