Spots Global Cancer Trial Database for Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer
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Trial Identification
Brief Title: Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer
Official Title: 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
Study ID: NCT00060398
Study Description
Brief Summary: RATIONALE: Epoetin alfa may stimulate red blood cell production and may help improve cancer-related anemia and fatigue. Steroid therapy with dexamethasone may increase the effectiveness of epoetin alfa. It is not yet known if epoetin alfa is more effective with or without dexamethasone in treating anemia-related fatigue in patients with prostate cancer. PURPOSE: This randomized phase III trial is studying epoetin alfa and dexamethasone to see how well they work compared to epoetin alfa alone in treating anemia-related fatigue in patients with prostate cancer that is refractory to treatment with hormone therapy.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Memorial Medical Center Cancer Services, Modesto, California, United States
Aurora Presbyterian Hospital, Aurora, Colorado, United States
Boulder Community Hospital, Boulder, Colorado, United States
Penrose Cancer Center at Penrose Hospital, Colorado Springs, Colorado, United States
Porter Adventist Hospital, Denver, Colorado, United States
Presbyterian - St. Luke's Medical Center, Denver, Colorado, United States
St. Joseph Hospital, Denver, Colorado, United States
Rose Medical Center, Denver, Colorado, United States
CCOP - Colorado Cancer Research Program, Incorporated, Denver, Colorado, United States
Swedish Medical Center, Englewood, Colorado, United States
Sky Ridge Medical Center, Lone Tree, Colorado, United States
Hope Cancer Care Center at Longmont United Hospital, Longmont, Colorado, United States
St. Mary-Corwin Regional Medical Center, Pueblo, Colorado, United States
North Suburban Medical Center, Thornton, Colorado, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa, Florida, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
Veterans Affairs Medical Center - Atlanta (Decatur), Decatur, Georgia, United States
Rush-Copley Cancer Care Center, Aurora, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States
Hematology and Oncology Associates, Chicago, Illinois, United States
Veterans Affairs Medical Center - Lakeside Chicago, Chicago, Illinois, United States
Mercy Hospital and Medical Center, Chicago, Illinois, United States
Swedish Covenant Hospital, Chicago, Illinois, United States
St. Anthony's Memorial Hospital, Effingham, Illinois, United States
Elmhurst Memorial Hospital, Elmhurst, Illinois, United States
Hinsdale Hematology Oncology Associates, Hinsdale, Illinois, United States
Midwest Center for Hematology/Oncology, Joliet, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois, United States
North Shore Oncology and Hematology Associates, Limited - Libertyville, Libertyville, Illinois, United States
Northwest Medical Specialist, PC, Niles, Illinois, United States
Hematology/Oncology of the North Shore at Gross Point Medical Center, Skokie, Illinois, United States
Midwest Cancer Research Group, Incorporated, Skokie, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
McFarland Clinic, P. C., Ames, Iowa, United States
Mercy Capitol Hospital, Des Moines, Iowa, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center, Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates - West Des Moines, West Des Moines, Iowa, United States
Cancer Center of Kansas, P.A. - Chanute, Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City, Dodge City, Kansas, United States
Cancer Center of Kansas, P.A. - El Dorado, El Dorado, Kansas, United States
Cancer Center of Kansas, P.A. - Kingman, Kingman, Kansas, United States
Southwest Medical Center, Liberal, Kansas, United States
Cancer Center of Kansas, P.A. - Newton, Newton, Kansas, United States
Cancer Center of Kansas, P.A. - Parsons, Parsons, Kansas, United States
Cancer Center of Kansas, P.A. - Pratt, Pratt, Kansas, United States
Cancer Center of Kansas, P.A. - Salina, Salina, Kansas, United States
Cancer Center of Kansas, P.A. - Wellington, Wellington, Kansas, United States
Associates in Womens Health, P.A. - North Review, Wichita, Kansas, United States
Cancer Center of Kansas, P.A. - Medical Arts Tower, Wichita, Kansas, United States
Cancer Center of Kansas, P.A. - Wichita, Wichita, Kansas, United States
CCOP - Wichita, Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas, United States
Cancer Center of Kansas, P.A. - Winfield, Winfield, Kansas, United States
Pennington Cancer Center at Baton Rouge General, Baton Rouge, Louisiana, United States
Mary Bird Perkins Cancer Center - Baton Rouge, Baton Rouge, Louisiana, United States
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, United States
Medical Center of Louisiana - New Orleans, New Orleans, Louisiana, United States
Tufts - New England Medical Center, Boston, Massachusetts, United States
Lawrence Memorial Hospital of Medford, Medford, Massachusetts, United States
Commonwealth Hematology-Oncology P. C. - Quincy, Quincy, Massachusetts, United States
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital, Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States
Foote Hospital, Jackson, Michigan, United States
Borgess Medical Center, Kalamazoo, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Bronson Methodist Hospital, Kalamazoo, Michigan, United States
Sparrow Regional Cancer Center, Lansing, Michigan, United States
Seton Cancer Institute - Saginaw, Saginaw, Michigan, United States
St. John Macomb Hospital, Warren, Michigan, United States
MeritCare Clinic - Bemidji, Bemidji, Minnesota, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota, United States
CCOP - Duluth, Duluth, Minnesota, United States
Miller-Dwan Medical Center, Duluth, Minnesota, United States
St. Mary's - Duluth Clinic Cancer Center, Duluth, Minnesota, United States
Fairview Southdale Hospital, Edina, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center, Robbinsdale, Minnesota, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
Park Nicollet Health Services, Saint Louis Park, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
Ridgeview Medical Center, Waconia, Minnesota, United States
University Medical Center of Southern Nevada, Las Vegas, Nevada, United States
CCOP - Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Veterans Affairs Medical Center - East Orange, East Orange, New Jersey, United States
Fox Chase Virtua Health Cancer Program - Marlton, Marlton, New Jersey, United States
Shore Memorial Hospital - Somers Point, Somers Point, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey, Voorhees, New Jersey, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center, Bronx, New York, United States
CCOP - MeritCare Hospital, Fargo, North Dakota, United States
MeritCare Medical Group, Fargo, North Dakota, United States
Aultman Hospital Cancer Center at Aultman Health Foundation, Canton, Ohio, United States
Adena Regional Medical Center, Chillicothe, Ohio, United States
Case Comprehensive Cancer Center, Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Riverside Methodist Hospital Cancer Care, Columbus, Ohio, United States
CCOP - Columbus, Columbus, Ohio, United States
Grant Riverside Cancer Services, Columbus, Ohio, United States
Mount Carmel West Hospital, Columbus, Ohio, United States
Doctors Hospital at Ohio Health, Columbus, Ohio, United States
Grady Memorial Hospital, Delaware, Ohio, United States
Fairfield Medical Center, Lancaster, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital, Marietta, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital, Newark, Ohio, United States
Mercy Medical Center, Springfield, Ohio, United States
Community Hospital of Springfield and Clark County, Springfield, Ohio, United States
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital, Westerville, Ohio, United States
Genesis - Good Samaritan Hospital, Zanesville, Ohio, United States
Bryn Mawr Hospital, Bryn Mawr, Pennsylvania, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Paoli Memorial Hospital, Paoli, Pennsylvania, United States
Albert Einstein Cancer Center, Philadelphia, Pennsylvania, United States
Reading Hospital and Medical Center, Reading, Pennsylvania, United States
Geisinger Medical Group, State College, Pennsylvania, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre, Pennsylvania, United States
CCOP - MainLine Health, Wynnewood, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital, Wynnewood, Pennsylvania, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Medical X-Ray Center, PC, Sioux Falls, South Dakota, United States
Sioux Valley Hospital and University of South Dakota Medical Center, Sioux Falls, South Dakota, United States
MBCCOP - Meharry Medical College - Nashville, Nashville, Tennessee, United States
CCOP - Scott and White Hospital, Temple, Texas, United States
Green Bay Oncology, Limited at St. Vincent Hospital, Green Bay, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay, Wisconsin, United States
St. Mary's Hospital Medical Center - Green Bay, Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States
Dean Medical Center - Fish Hatchery, Madison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
Holy Family Memorial Medical Center Cancer Care Center, Manitowoc, Wisconsin, United States
Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin, United States
Contact Details
Name: Shirley S. Hwang, RN, MS
Affiliation: Veterans Affairs Medical Center - East Orange
Role: STUDY_CHAIR
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