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| Sponsor: | Eastern Cooperative Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00060398 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anemia Fatigue Prostate Cancer |
Biological: epoetin alfa Drug: dexamethasone |
Phase III |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Active Control |
| 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 |
| Estimated Enrollment: | 282 |
| Study Start Date: | June 2004 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer
Prior bilateral orchiectomy OR other primary hormonal therapy (e.g., estrogen therapy or luteinizing hormone-releasing hormone analog [LHRH] and flutamide) with evidence of treatment failure
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
More than 30 days since prior corticosteroids for hormone-refractory prostate cancer
Radiotherapy
Surgery
Other
Contacts and Locations
Hide Study Locations| United States, California | |
| Memorial Medical Center Cancer Services | |
| Modesto, California, United States, 95355 | |
| United States, Colorado | |
| Aurora Presbyterian Hospital | |
| Aurora, Colorado, United States, 80012 | |
| Boulder Community Hospital | |
| Boulder, Colorado, United States, 80301-9019 | |
| CCOP - Colorado Cancer Research Program, Incorporated | |
| Denver, Colorado, United States, 80224-2522 | |
| Porter Adventist Hospital | |
| Denver, Colorado, United States, 80210 | |
| North Suburban Medical Center | |
| Thorton, Colorado, United States, 80229 | |
| Penrose Cancer Center at Penrose Hospital | |
| Colorado Springs, Colorado, United States, 80933 | |
| Hope Cancer Care Center at Longmont United Hospital | |
| Longmont, Colorado, United States, 80502 | |
| Presbyterian - St. Luke's Medical Center | |
| Denver, Colorado, United States, 80218 | |
| Rose Medical Center | |
| Denver, Colorado, United States, 80220 | |
| Sky Ridge Medical Center | |
| Lone Tree, Colorado, United States, 80124 | |
| St. Joseph Hospital | |
| Denver, Colorado, United States, 80218 | |
| St. Mary-Corwin Regional Medical Center | |
| Pueblo, Colorado, United States, 81004 | |
| Swedish Medical Center | |
| Englewood, Colorado, United States, 80110 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | |
| Tampa, Florida, United States, 33612-9497 | |
| United States, Georgia | |
| Veterans Affairs Medical Center - Atlanta (Decatur) | |
| Decatur, Georgia, United States, 30033 | |
| Winship Cancer Institute of Emory University | |
| Altanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Carle Cancer Center at Carle Foundation Hospital | |
| Urbana, Illinois, United States, 61801 | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| Elmhurst Memorial Hospital | |
| Elmhurst, Illinois, United States, 60126 | |
| Hematology and Oncology Associates | |
| Chicago, Illinois, United States, 60611 | |
| Hematology/Oncology of the North Shore at Gross Point Medical Center | |
| Skokie, Illinois, United States, 60076 | |
| Midwest Cancer Research Group, Incorporated | |
| Skokie, Illinois, United States, 60077 | |
| Joliet Oncology-Hematology Associates, Limited - West | |
| Joliet, Illinois, United States, 60435 | |
| Mercy Hospital and Medical Center | |
| Chicago, Illinois, United States, 60616 | |
| Hinsdale Hematology Oncology Associates | |
| Hinsdale, Illinois, United States, 60521 | |
| Midwest Center for Hematology/Oncology | |
| Joliet, Illinois, United States, 60432 | |
| North Shore Oncology and Hematology Associates, Limited - Libertyville | |
| Libertyville, Illinois, United States, 60048 | |
| Northwest Medical Specialist, PC | |
| Niles, Illinois, United States, 60714 | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| Rush-Copley Cancer Care Center | |
| Aurora, Illinois, United States, 60507 | |
| St. Anthony's Memorial Hospital | |
| Effingham, Illinois, United States, 62401 | |
| Swedish Covenant Hospital | |
| Chicago, Illinois, United States, 60625 | |
| Veterans Affairs Medical Center - Lakeside Chicago | |
| Chicago, Illinois, United States, 60611 | |
| United States, Iowa | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309 | |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | |
| Des Moines, Iowa, United States, 50316-2301 | |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | |
| Des Moines, Iowa, United States, 50309 | |
| McFarland Clinic, P. C. | |
| Ames, Iowa, United States, 50010 | |
| Medical Oncology and Hematology Associates - West Des Moines | |
| West Des Moines, Iowa, United States, 50266 | |
| Mercy Capitol Hospital | |
| Des Moines, Iowa, United States, 50307 | |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | |
| Des Moines, Iowa, United States, 50314 | |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | |
| Des Moines, Iowa, United States, 50314 | |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | |
| Des Moines, Iowa, United States, 50309 | |
| United States, Kansas | |
| Associates in Womens Health, P.A. - North Review | |
| Wichita, Kansas, United States, 67203 | |
| Cancer Center of Kansas, P.A. - Salina | |
| Salina, Kansas, United States, 67042 | |
| Cancer Center of Kansas, P.A. - Chanute | |
| Chanute, Kansas, United States, 66720 | |
| Cancer Center of Kansas, P.A. - El Dorado | |
| El Dorado, Kansas, United States, 67042 | |
| Cancer Center of Kansas, P.A. - Kingman | |
| Kingman, Kansas, United States, 67068 | |
| Cancer Center of Kansas, P.A. - Medical Arts Tower | |
| Wichita, Kansas, United States, 67208 | |
| Cancer Center of Kansas, P.A. - Newton | |
| Newton, Kansas, United States, 67114 | |
| Cancer Center of Kansas, P.A. - Parsons | |
| Parsons, Kansas, United States, 67357 | |
| Cancer Center of Kansas, P.A. - Pratt | |
| Pratt, Kansas, United States, 67124 | |
| Cancer Center of Kansas, P.A. - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| Cancer Center of Kansas, P.A. - Wellington | |
| Wellington, Kansas, United States, 67152 | |
| Cancer Center of Kansas, P.A. - Winfield | |
| Winfield, Kansas, United States, 67156 | |
| Cancer Center of Kansas, PA - Dodge City | |
| Dodge City, Kansas, United States, 67801 | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| Southwest Medical Center | |
| Liberal, Kansas, United States, 67901 | |
| Via Christi Cancer Center at Via Christi Regional Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| United States, Louisiana | |
| Mary Bird Perkins Cancer Center - Baton Rouge | |
| Baton Rouge, Louisiana, United States, 70809 | |
| MBCCOP - LSU Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| Medical Center of Louisiana - New Orleans | |
| New Orleans, Louisiana, United States, 70112 | |
| Pennington Cancer Center at Baton Rouge General | |
| Baton Rouge, Louisiana, United States, 70806 | |
| United States, Massachusetts | |
| Commonwealth Hematology-Oncology P. C. - Quincy | |
| Quincy, Massachusetts, United States, 02169 | |
| Lawrence Memorial Hospital of Medford | |
| Medford, Massachusetts, United States, 02155 | |
| Tufts - New England Medical Center | |
| Boston, Massachusetts, United States, 02111 | |
| United States, Michigan | |
| Foote Hospital | |
| Jackson, Michigan, United States, 49201 | |
| Bronson Methodist Hospital | |
| Kalamazoo, Michigan, United States, 49007 | |
| CCOP - Michigan Cancer Research Consortium | |
| Ann Arbor, Michigan, United States, 48106 | |
| Borgess Medical Center | |
| Kalamazooaa, Michigan, United States, 49001 | |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | |
| Dearborn, Michigan, United States, 48123-2500 | |
| Seton Cancer Institute - Saginaw | |
| Saginaw, Michigan, United States, 48601 | |
| Sparrow Regional Cancer Center | |
| Lansing, Michigan, United States, 48909 | |
| St. John Macomb Hospital | |
| Warren, Michigan, United States, 48093 | |
| West Michigan Cancer Center | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | |
| Grosse Pointe Woods, Michigan, United States, 48236 | |
| St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital | |
| Ann Arbor, Michigan, United States, 48106-0995 | |
| United States, Minnesota | |
| CCOP - Duluth | |
| Duluth, Minnesota, United States, 55805 | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| Ridgeview Medical Center | |
| Waconia, Minnesota, United States, 55387 | |
| Fairview Southdale Hospital | |
| Edina, Minnesota, United States, 55435 | |
| Hubert H. Humphrey Cancer Center at North Memorial Medical Center | |
| Robbinsdale, Minnesota, United States, 55422-2900 | |
| Mercy and Unity Cancer Center at Unity Hospital | |
| Fridley, Minnesota, United States, 55432 | |
| Mercy and Unity Cancer Center at Mercy Hospital | |
| Coon Rapids, Minnesota, United States, 55433 | |
| MeritCare Clinic - Bemidji | |
| Bemidji, Minnesota, United States, 56601 | |
| Miller-Dwan Medical Center | |
| Duluth, Minnesota, United States, 55805 | |
| Park Nicollet Health Services | |
| St. Louis Park, Minnesota, United States, 55416 | |
| Fairview Ridges Hospital | |
| Burnsville, Minnesota, United States, 55337 | |
| St. Mary's - Duluth Clinic Cancer Center | |
| Duluth, Minnesota, United States, 55805 | |
| United Hospital | |
| St. Paul, Minnesota, United States, 55102 | |
| Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | |
| Minneapolis, Minnesota, United States, 55407 | |
| United States, Nevada | |
| CCOP - Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89106 | |
| University Medical Center of Southern Nevada | |
| Las Vegas, Nevada, United States, 89102 | |
| United States, New Jersey | |
| Veterans Affairs Medical Center - East Orange | |
| East Orange, New Jersey, United States, 07018-1095 | |
| Fox Chase Virtua Health Cancer Program - Marlton | |
| Marlton, New Jersey, United States, 08053 | |
| Shore Memorial Hospital - Somers Point | |
| Somers Point, New Jersey, United States, 08244 | |
| Fox Chase Virtua Health Cancer Program at Virtua West Jersey | |
| Voorhees, New Jersey, United States, 08043 | |
| United States, New York | |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | |
| Bronx, New York, United States, 10461 | |
| Our Lady of Mercy Medical Center Comprehensive Cancer Center | |
| Bronx, New York, United States, 10466 | |
| United States, North Dakota | |
| CCOP - MeritCare Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| MeritCare Medical Group | |
| Fargo, North Dakota, United States, 58122 | |
| United States, Ohio | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43215 | |
| Aultman Hospital Cancer Center at Aultman Health Foundation | |
| Canton, Ohio, United States, 44710-1799 | |
| Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106 | |
| Adena Regional Medical Center | |
| Chillicothe, Ohio, United States, 45601 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Community Hospital of Springfield and Clark County | |
| Springfield, Ohio, United States, 45505 | |
| Doctors Hospital at Ohio Health | |
| Columbus, Ohio, United States, 43228 | |
| Fairfield Medical Center | |
| Lancaster, Ohio, United States, 43130 | |
| Genesis - Good Samaritan Hospital | |
| Zanesville, Ohio, United States, 43701 | |
| Mercy Medical Center | |
| Springfield, Ohio, United States, 45504 | |
| Grant Riverside Cancer Services | |
| Columbus, Ohio, United States, 43215 | |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | |
| Newark, Ohio, United States, 43055 | |
| Grady Memorial Hospital | |
| Delaware, Ohio, United States, 43015 | |
| Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital | |
| Westerville, Ohio, United States, 43081 | |
| Mount Carmel West Hospital | |
| Columbus, Ohio, United States, 43222 | |
| Riverside Methodist Hospital Cancer Care | |
| Columbus, Ohio, United States, 43214-3998 | |
| Strecker Cancer Center at Marietta Memorial Hospital | |
| Marietta, Ohio, United States, 45750 | |
| United States, Pennsylvania | |
| Albert Einstein Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19141 | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822-0001 | |
| CCOP - MainLine Health | |
| Wynnewood, Pennsylvania, United States, 19096 | |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | |
| Wilkes-Barre, Pennsylvania, United States, 18711 | |
| Bryn Mawr Hospital | |
| Bryn Mawr, Pennsylvania, United States, 19010 | |
| Geisinger Medical Group | |
| State College, Pennsylvania, United States, 16801 | |
| Lankenau Cancer Center at Lankenau Hospital | |
| Wynnewood, Pennsylvania, United States, 19096 | |
| Paoli Memorial Hospital | |
| Paoli, Pennsylvania, United States, 19301-1792 | |
| Reading Hospital and Medical Center | |
| Reading, Pennsylvania, United States, 19612-6052 | |
| United States, South Dakota | |
| Avera Cancer Institute | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Medical X-Ray Center, PC | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Sioux Valley Hospital and University of South Dakota Medical Center | |
| Sioux Falls, South Dakota, United States, 57117-5039 | |
| United States, Tennessee | |
| MBCCOP - Meharry Medical College - Nashville | |
| Nashville, Tennessee, United States, 37208-3599 | |
| United States, Texas | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| United States, Wisconsin | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-6164 | |
| Green Bay Oncology, Limited at St. Mary's Hospital | |
| Green Bay, Wisconsin, United States, 54303 | |
| Green Bay Oncology, Limited at St. Vincent Hospital | |
| Green Bay, Wisconsin, United States, 54301-3526 | |
| Holy Family Memorial Medical Center Cancer Care Center | |
| Manitowoc, Wisconsin, United States, 54221-1450 | |
| Marshfield Clinic - Marshfield Center | |
| Marshfield, Wisconsin, United States, 54449 | |
| St. Mary's Hospital Medical Center - Green Bay | |
| Green Bay, Wisconsin, United States, 54303 | |
| St. Vincent Hospital Regional Cancer Center | |
| Green Bay, Wisconsin, United States, 54307-3508 | |
| Dean Medical Center - Fish Hatchery | |
| Madison, Wisconsin, United States, 53715 | |
| Study Chair: | Shirley S. Hwang, RN, MS | Veterans Affairs Medical Center - East Orange |
More Information
| Study ID Numbers: | CDR0000301881, ECOG-E1Z01 |
| Study First Received: | May 6, 2003 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00060398 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent prostate cancer anemia fatigue |
|
Anti-Inflammatory Agents Dexamethasone Epoetin Alfa Prostatic Diseases Genital Neoplasms, Male Antineoplastic Agents Hematologic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Urogenital Neoplasms Hormones Signs and Symptoms Neoplasms by Site Therapeutic Uses |
Dexamethasone acetate Fatigue Antineoplastic Agents, Hormonal Hematinics Hematologic Diseases Anemia Gastrointestinal Agents Genital Diseases, Male Glucocorticoids Pharmacologic Actions Neoplasms Autonomic Agents Peripheral Nervous System Agents Prostatic Neoplasms Central Nervous System Agents |