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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00060398
Other study ID # CDR0000301881
Secondary ID ECOG-E1Z01
Status Completed
Phase Phase 3
First received
Last updated
Start date September 29, 2004

Study information

Verified date June 2023
Source Eastern Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 282
Est. completion date
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 120 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
epoetin alfa

Drug:
dexamethasone


Locations

Country Name City State
United States McFarland Clinic, P. C. Ames Iowa
United States CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan
United States St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital Ann Arbor Michigan
United States Winship Cancer Institute of Emory University Atlanta Georgia
United States Aurora Presbyterian Hospital Aurora Colorado
United States Rush-Copley Cancer Care Center Aurora Illinois
United States Mary Bird Perkins Cancer Center - Baton Rouge Baton Rouge Louisiana
United States Pennington Cancer Center at Baton Rouge General Baton Rouge Louisiana
United States MeritCare Clinic - Bemidji Bemidji Minnesota
United States Tufts - New England Medical Center Boston Massachusetts
United States Boulder Community Hospital Boulder Colorado
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 Bryn Mawr Hospital Bryn Mawr Pennsylvania
United States Fairview Ridges Hospital Burnsville Minnesota
United States Aultman Hospital Cancer Center at Aultman Health Foundation Canton Ohio
United States Cancer Center of Kansas, P.A. - Chanute Chanute Kansas
United States Hematology and Oncology Associates Chicago Illinois
United States Mercy Hospital and Medical Center Chicago Illinois
United States Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago Illinois
United States Swedish Covenant Hospital Chicago Illinois
United States Veterans Affairs Medical Center - Lakeside Chicago Chicago Illinois
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 Penrose Cancer Center at Penrose Hospital Colorado Springs Colorado
United States CCOP - Columbus Columbus Ohio
United States Doctors Hospital at Ohio Health Columbus Ohio
United States Grant Riverside Cancer Services Columbus Ohio
United States Mount Carmel West Hospital Columbus Ohio
United States Riverside Methodist Hospital Cancer Care Columbus Ohio
United States Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids Minnesota
United States Geisinger Medical Center Danville Pennsylvania
United States Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn Michigan
United States Veterans Affairs Medical Center - Atlanta (Decatur) Decatur Georgia
United States Grady Memorial Hospital Delaware Ohio
United States CCOP - Colorado Cancer Research Program, Incorporated Denver Colorado
United States Porter Adventist Hospital Denver Colorado
United States Presbyterian - St. Luke's Medical Center Denver Colorado
United States Rose Medical Center Denver Colorado
United States St. Joseph Hospital Denver Colorado
United States CCOP - Iowa Oncology Research Association Des Moines Iowa
United States John Stoddard Cancer Center at Iowa Lutheran Hospital 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 Mercy Capitol Hospital Des Moines Iowa
United States Cancer Center of Kansas, PA - Dodge City Dodge City Kansas
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 Veterans Affairs Medical Center - East Orange East Orange New Jersey
United States Fairview Southdale Hospital Edina Minnesota
United States St. Anthony's Memorial Hospital Effingham Illinois
United States Cancer Center of Kansas, P.A. - El Dorado El Dorado Kansas
United States Elmhurst Memorial Hospital Elmhurst Illinois
United States Swedish Medical Center Englewood Colorado
United States CCOP - MeritCare Hospital Fargo North Dakota
United States MeritCare Medical Group Fargo North Dakota
United States Mercy and Unity Cancer Center at Unity Hospital Fridley Minnesota
United States Green Bay Oncology, Limited at St. Mary's Hospital Green Bay Wisconsin
United States Green Bay Oncology, Limited at St. Vincent 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 Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods Michigan
United States Hinsdale Hematology Oncology Associates Hinsdale Illinois
United States Foote Hospital Jackson Michigan
United States Joliet Oncology-Hematology Associates, Limited - West Joliet Illinois
United States Midwest Center for Hematology/Oncology Joliet Illinois
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Cancer Center of Kansas, P.A. - Kingman Kingman Kansas
United States Fairfield Medical Center Lancaster Ohio
United States Sparrow Regional Cancer Center Lansing Michigan
United States CCOP - Nevada Cancer Research Foundation Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Southwest Medical Center Liberal Kansas
United States North Shore Oncology and Hematology Associates, Limited - Libertyville Libertyville Illinois
United States Sky Ridge Medical Center Lone Tree Colorado
United States Hope Cancer Care Center at Longmont United Hospital Longmont Colorado
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 Strecker Cancer Center at Marietta Memorial Hospital Marietta Ohio
United States Fox Chase Virtua Health Cancer Program - Marlton Marlton New Jersey
United States Marshfield Clinic - Marshfield Center Marshfield Wisconsin
United States Lawrence Memorial Hospital of Medford Medford Massachusetts
United States Virginia Piper Cancer Institute at Abbott-Northwestern Hospital Minneapolis Minnesota
United States Memorial Medical Center Cancer Services Modesto California
United States MBCCOP - Meharry Medical College - Nashville Nashville Tennessee
United States MBCCOP - LSU Health Sciences Center New Orleans Louisiana
United States Medical Center of Louisiana - New Orleans New Orleans Louisiana
United States Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark Ohio
United States Cancer Center of Kansas, P.A. - Newton Newton Kansas
United States Northwest Medical Specialist, PC Niles Illinois
United States Paoli Memorial Hospital Paoli Pennsylvania
United States Cancer Center of Kansas, P.A. - Parsons Parsons Kansas
United States Albert Einstein Cancer Center Philadelphia Pennsylvania
United States Cancer Center of Kansas, P.A. - Pratt Pratt Kansas
United States St. Mary-Corwin Regional Medical Center Pueblo Colorado
United States Commonwealth Hematology-Oncology P. C. - Quincy Quincy Massachusetts
United States Reading Hospital and Medical Center Reading Pennsylvania
United States Hubert H. Humphrey Cancer Center at North Memorial Medical Center Robbinsdale Minnesota
United States Seton Cancer Institute - Saginaw Saginaw Michigan
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 Cancer Center of Kansas, P.A. - Salina Salina Kansas
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 Hematology/Oncology of the North Shore at Gross Point Medical Center Skokie Illinois
United States Midwest Cancer Research Group, Incorporated Skokie Illinois
United States Shore Memorial Hospital - Somers Point Somers Point New Jersey
United States Community Hospital of Springfield and Clark County Springfield Ohio
United States Mercy Medical Center Springfield Ohio
United States Geisinger Medical Group State College Pennsylvania
United States H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Tampa Florida
United States CCOP - Scott and White Hospital Temple Texas
United States North Suburban Medical Center Thornton Colorado
United States Carle Cancer Center at Carle Foundation Hospital Urbana Illinois
United States CCOP - Carle Cancer Center Urbana Illinois
United States Fox Chase Virtua Health Cancer Program at Virtua West Jersey Voorhees New Jersey
United States Ridgeview Medical Center Waconia Minnesota
United States St. John Macomb Hospital Warren Michigan
United States Cancer Center of Kansas, P.A. - Wellington Wellington Kansas
United States Medical Oncology and Hematology Associates - West Des Moines West Des Moines Iowa
United States Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital Westerville Ohio
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 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre Pennsylvania
United States Cancer Center of Kansas, P.A. - Winfield Winfield Kansas
United States CCOP - MainLine Health Wynnewood Pennsylvania
United States Lankenau Cancer Center at Lankenau Hospital Wynnewood Pennsylvania
United States Genesis - Good Samaritan Hospital Zanesville Ohio

Sponsors (2)

Lead Sponsor Collaborator
Eastern Cooperative Oncology Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fatigue response as measured by the Functional Assessment of Chronic Illness Therapy Fatigue Subscale
Secondary Anemia response at 3 months
Secondary Functional level as measured by the Functional Assessment of Cancer Therapy-General Scale and Brief Fatigue Inventory functional interference score monthly
Secondary Symptom distress as measured by the Memorial Symptom Assessment Scale-Short Form and the number of symptoms monthly
Secondary Quality of life as measured by the Functional Assessment of Cancer Therapy-General Scale monthly
Secondary Survival at 6 months
Secondary Adrenal suppression
Secondary Toxicity
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