Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer
Anemia, Fatigue, Prostate Cancer
About this trial
This is an interventional supportive care trial for Anemia focused on measuring recurrent prostate cancer, anemia, fatigue
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed prostate cancer Hormone-refractory disease as evidenced by progression on bone scan or CT scan with a rising prostate-specific antigen 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 Concurrent continual LHRH agonist therapy (e.g., depot leuprolide or goserelin) required for patients who have not undergone bilateral orchiectomy Must have anemia with hemoglobin ≥ 8 g/dL and < 12 g/dL within the past 14 days Must be iron replete (i.e., ferritin > 50 ng/mL) within the past 30 days Presence of fatigue with usual fatigue severity ≥ 3 on the 0-10 numerical scale of the Brief Fatigue Inventory within the past 14 days PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-3 Life expectancy Not specified Hematopoietic See Disease Characteristics No disseminated intravascular coagulation No autoimmune hemolytic anemia Hepatic AST and ALT ≤ 2 times upper limit of normal No prior hemochromatosis or iron intolerance Renal Creatinine < 2.5 mg/dL Cardiovascular Adequate blood pressure (i.e., systolic blood pressure < 140 mm Hg and diastolic blood pressure < 90 mm Hg) (treated or untreated) No history of thromboembolic events No unstable angina No poorly controlled cardiac disease Other Fertile patients must use effective contraception Able to read, understand, and answer questions on the symptom and quality of life study instruments No ongoing chronic hemorrhage (e.g., gross hematuria due to advanced prostate cancer)* NOTE: *Microscopic hematuria allowed No acute or subacute illness that may require transfusion No gastrointestinal bleeding No active systemic infection No known or suspected hypersensitivity to human albumin No known or suspected hypersensitivity to mammalian cell-derived products No uncontrolled diabetes PRIOR CONCURRENT THERAPY: Biologic therapy More than 30 days since prior epoetin alfa Chemotherapy More than 21 days since prior chemotherapy No more than 2 different types of prior chemotherapy regimens for hormone-refractory prostate cancer Endocrine therapy See Disease Characteristics More than 30 days since prior corticosteroids for hormone-refractory prostate cancer Episodic use of low-dose steroids for other causes is allowed Radiotherapy More than 21 days since prior radiotherapy Concurrent radiotherapy allowed Surgery See Disease Characteristics Other More than 8 weeks since prior blood transfusion No concurrent oral or intravenous antibiotics
Sites / Locations
- Memorial Medical Center Cancer Services
- Aurora Presbyterian Hospital
- Boulder Community Hospital
- Penrose Cancer Center at Penrose Hospital
- Porter Adventist Hospital
- Presbyterian - St. Luke's Medical Center
- St. Joseph Hospital
- Rose Medical Center
- CCOP - Colorado Cancer Research Program, Incorporated
- Swedish Medical Center
- Sky Ridge Medical Center
- Hope Cancer Care Center at Longmont United Hospital
- St. Mary-Corwin Regional Medical Center
- North Suburban Medical Center
- H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
- Winship Cancer Institute of Emory University
- Veterans Affairs Medical Center - Atlanta (Decatur)
- Rush-Copley Cancer Care Center
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- Hematology and Oncology Associates
- Veterans Affairs Medical Center - Lakeside Chicago
- Mercy Hospital and Medical Center
- Swedish Covenant Hospital
- St. Anthony's Memorial Hospital
- Elmhurst Memorial Hospital
- Hinsdale Hematology Oncology Associates
- Midwest Center for Hematology/Oncology
- Joliet Oncology-Hematology Associates, Limited - West
- North Shore Oncology and Hematology Associates, Limited - Libertyville
- Northwest Medical Specialist, PC
- Hematology/Oncology of the North Shore at Gross Point Medical Center
- Midwest Cancer Research Group, Incorporated
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- McFarland Clinic, P. C.
- Mercy Capitol Hospital
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- Medical Oncology and Hematology Associates - West Des Moines
- Cancer Center of Kansas, P.A. - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, P.A. - El Dorado
- Cancer Center of Kansas, P.A. - Kingman
- Southwest Medical Center
- Cancer Center of Kansas, P.A. - Newton
- Cancer Center of Kansas, P.A. - Parsons
- Cancer Center of Kansas, P.A. - Pratt
- Cancer Center of Kansas, P.A. - Salina
- Cancer Center of Kansas, P.A. - Wellington
- Associates in Womens Health, P.A. - North Review
- Cancer Center of Kansas, P.A. - Medical Arts Tower
- Cancer Center of Kansas, P.A. - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, P.A. - Winfield
- Pennington Cancer Center at Baton Rouge General
- Mary Bird Perkins Cancer Center - Baton Rouge
- MBCCOP - LSU Health Sciences Center
- Medical Center of Louisiana - New Orleans
- Tufts - New England Medical Center
- Lawrence Memorial Hospital of Medford
- Commonwealth Hematology-Oncology P. C. - Quincy
- St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
- CCOP - Michigan Cancer Research Consortium
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Foote Hospital
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Sparrow Regional Cancer Center
- Seton Cancer Institute - Saginaw
- St. John Macomb Hospital
- MeritCare Clinic - Bemidji
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- CCOP - Duluth
- Miller-Dwan Medical Center
- St. Mary's - Duluth Clinic Cancer Center
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
- CCOP - Metro-Minnesota
- Park Nicollet Health Services
- United Hospital
- Ridgeview Medical Center
- University Medical Center of Southern Nevada
- CCOP - Nevada Cancer Research Foundation
- Veterans Affairs Medical Center - East Orange
- Fox Chase Virtua Health Cancer Program - Marlton
- Shore Memorial Hospital - Somers Point
- Fox Chase Virtua Health Cancer Program at Virtua West Jersey
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
- Our Lady of Mercy Medical Center Comprehensive Cancer Center
- CCOP - MeritCare Hospital
- MeritCare Medical Group
- Aultman Hospital Cancer Center at Aultman Health Foundation
- Adena Regional Medical Center
- Case Comprehensive Cancer Center
- Cleveland Clinic Taussig Cancer Center
- Riverside Methodist Hospital Cancer Care
- CCOP - Columbus
- Grant Riverside Cancer Services
- Mount Carmel West Hospital
- Doctors Hospital at Ohio Health
- Grady Memorial Hospital
- Fairfield Medical Center
- Strecker Cancer Center at Marietta Memorial Hospital
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
- Mercy Medical Center
- Community Hospital of Springfield and Clark County
- Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
- Genesis - Good Samaritan Hospital
- Bryn Mawr Hospital
- Geisinger Medical Center
- Paoli Memorial Hospital
- Albert Einstein Cancer Center
- Reading Hospital and Medical Center
- Geisinger Medical Group
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- CCOP - MainLine Health
- Lankenau Cancer Center at Lankenau Hospital
- Avera Cancer Institute
- Medical X-Ray Center, PC
- Sioux Valley Hospital and University of South Dakota Medical Center
- MBCCOP - Meharry Medical College - Nashville
- CCOP - Scott and White Hospital
- Green Bay Oncology, Limited at St. Vincent Hospital
- Green Bay Oncology, Limited at St. Mary's Hospital
- St. Mary's Hospital Medical Center - Green Bay
- St. Vincent Hospital Regional Cancer Center
- Dean Medical Center - Fish Hatchery
- University of Wisconsin Comprehensive Cancer Center
- Holy Family Memorial Medical Center Cancer Care Center
- Marshfield Clinic - Marshfield Center