Prostate Cancer Clinical Trial

Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer

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.

View Full Description

Full 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.

View Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

282

Study ID:

NCT00060398

Recruitment Status:

Completed

Sponsor:

Eastern Cooperative Oncology Group

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 119 Locations for this study

See Locations Near You

Memorial Medical Center Cancer Services
Modesto California, 95355, United States
Aurora Presbyterian Hospital
Aurora Colorado, 80012, United States
Boulder Community Hospital
Boulder Colorado, 80301, United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs Colorado, 80933, United States
Porter Adventist Hospital
Denver Colorado, 80210, United States
Presbyterian - St. Luke's Medical Center
Denver Colorado, 80218, United States
St. Joseph Hospital
Denver Colorado, 80218, United States
Rose Medical Center
Denver Colorado, 80220, United States
CCOP - Colorado Cancer Research Program, Incorporated
Denver Colorado, 80224, United States
Swedish Medical Center
Englewood Colorado, 80110, United States
Sky Ridge Medical Center
Lone Tree Colorado, 80124, United States
Hope Cancer Care Center at Longmont United Hospital
Longmont Colorado, 80502, United States
St. Mary-Corwin Regional Medical Center
Pueblo Colorado, 81004, United States
North Suburban Medical Center
Thornton Colorado, 80229, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa Florida, 33612, United States
Winship Cancer Institute of Emory University
Atlanta Georgia, 30322, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur Georgia, 30033, United States
Rush-Copley Cancer Care Center
Aurora Illinois, 60507, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago Illinois, 60611, United States
Hematology and Oncology Associates
Chicago Illinois, 60611, United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago Illinois, 60611, United States
Mercy Hospital and Medical Center
Chicago Illinois, 60616, United States
Swedish Covenant Hospital
Chicago Illinois, 60625, United States
St. Anthony's Memorial Hospital
Effingham Illinois, 62401, United States
Elmhurst Memorial Hospital
Elmhurst Illinois, 60126, United States
Hinsdale Hematology Oncology Associates
Hinsdale Illinois, 60521, United States
Midwest Center for Hematology/Oncology
Joliet Illinois, 60432, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet Illinois, 60435, United States
North Shore Oncology and Hematology Associates, Limited - Libertyville
Libertyville Illinois, 60048, United States
Northwest Medical Specialist, PC
Niles Illinois, 60714, United States
Hematology/Oncology of the North Shore at Gross Point Medical Center
Skokie Illinois, 60076, United States
Midwest Cancer Research Group, Incorporated
Skokie Illinois, 60077, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana Illinois, 61801, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
McFarland Clinic, P. C.
Ames Iowa, 50010, United States
Mercy Capitol Hospital
Des Moines Iowa, 50307, United States
CCOP - Iowa Oncology Research Association
Des Moines Iowa, 50309, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines Iowa, 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines Iowa, 50314, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines Iowa, 50316, United States
Medical Oncology and Hematology Associates - West Des Moines
West Des Moines Iowa, 50266, United States
Cancer Center of Kansas, P.A. - Chanute
Chanute Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City Kansas, 67801, United States
Cancer Center of Kansas, P.A. - El Dorado
El Dorado Kansas, 67042, United States
Cancer Center of Kansas, P.A. - Kingman
Kingman Kansas, 67068, United States
Southwest Medical Center
Liberal Kansas, 67901, United States
Cancer Center of Kansas, P.A. - Newton
Newton Kansas, 67114, United States
Cancer Center of Kansas, P.A. - Parsons
Parsons Kansas, 67357, United States
Cancer Center of Kansas, P.A. - Pratt
Pratt Kansas, 67124, United States
Cancer Center of Kansas, P.A. - Salina
Salina Kansas, 67042, United States
Cancer Center of Kansas, P.A. - Wellington
Wellington Kansas, 67152, United States
Associates in Womens Health, P.A. - North Review
Wichita Kansas, 67203, United States
Cancer Center of Kansas, P.A. - Medical Arts Tower
Wichita Kansas, 67208, United States
Cancer Center of Kansas, P.A. - Wichita
Wichita Kansas, 67214, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita Kansas, 67214, United States
Cancer Center of Kansas, P.A. - Winfield
Winfield Kansas, 67156, United States
Pennington Cancer Center at Baton Rouge General
Baton Rouge Louisiana, 70806, United States
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge Louisiana, 70809, United States
MBCCOP - LSU Health Sciences Center
New Orleans Louisiana, 70112, United States
Medical Center of Louisiana - New Orleans
New Orleans Louisiana, 70112, United States
Tufts - New England Medical Center
Boston Massachusetts, 02111, United States
Lawrence Memorial Hospital of Medford
Medford Massachusetts, 02155, United States
Commonwealth Hematology-Oncology P. C. - Quincy
Quincy Massachusetts, 02169, United States
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor Michigan, 48106, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn Michigan, 48123, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods Michigan, 48236, United States
Foote Hospital
Jackson Michigan, 49201, United States
Borgess Medical Center
Kalamazoo Michigan, 49001, United States
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
Sparrow Regional Cancer Center
Lansing Michigan, 48909, United States
Seton Cancer Institute - Saginaw
Saginaw Michigan, 48601, United States
St. John Macomb Hospital
Warren Michigan, 48093, United States
MeritCare Clinic - Bemidji
Bemidji Minnesota, 56601, United States
Fairview Ridges Hospital
Burnsville Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids Minnesota, 55433, United States
CCOP - Duluth
Duluth Minnesota, 55805, United States
Miller-Dwan Medical Center
Duluth Minnesota, 55805, United States
St. Mary's - Duluth Clinic Cancer Center
Duluth Minnesota, 55805, United States
Fairview Southdale Hospital
Edina Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley Minnesota, 55432, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale Minnesota, 55422, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
Park Nicollet Health Services
Saint Louis Park Minnesota, 55416, United States
United Hospital
Saint Paul Minnesota, 55102, United States
Ridgeview Medical Center
Waconia Minnesota, 55387, United States
University Medical Center of Southern Nevada
Las Vegas Nevada, 89102, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas Nevada, 89106, United States
Veterans Affairs Medical Center - East Orange
East Orange New Jersey, 07018, United States
Fox Chase Virtua Health Cancer Program - Marlton
Marlton New Jersey, 08053, United States
Shore Memorial Hospital - Somers Point
Somers Point New Jersey, 08244, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees New Jersey, 08043, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx New York, 10461, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center
Bronx New York, 10466, United States
CCOP - MeritCare Hospital
Fargo North Dakota, 58122, United States
MeritCare Medical Group
Fargo North Dakota, 58122, United States
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton Ohio, 44710, United States
Adena Regional Medical Center
Chillicothe Ohio, 45601, United States
Case Comprehensive Cancer Center
Cleveland Ohio, 44106, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
Riverside Methodist Hospital Cancer Care
Columbus Ohio, 43214, United States
CCOP - Columbus
Columbus Ohio, 43215, United States
Grant Riverside Cancer Services
Columbus Ohio, 43215, United States
Mount Carmel West Hospital
Columbus Ohio, 43222, United States
Doctors Hospital at Ohio Health
Columbus Ohio, 43228, United States
Grady Memorial Hospital
Delaware Ohio, 43015, United States
Fairfield Medical Center
Lancaster Ohio, 43130, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta Ohio, 45750, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark Ohio, 43055, United States
Mercy Medical Center
Springfield Ohio, 45504, United States
Community Hospital of Springfield and Clark County
Springfield Ohio, 45505, United States
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
Westerville Ohio, 43081, United States
Genesis - Good Samaritan Hospital
Zanesville Ohio, 43701, United States
Bryn Mawr Hospital
Bryn Mawr Pennsylvania, 19010, United States
Geisinger Medical Center
Danville Pennsylvania, 17822, United States
Paoli Memorial Hospital
Paoli Pennsylvania, 19301, United States
Albert Einstein Cancer Center
Philadelphia Pennsylvania, 19141, United States
Reading Hospital and Medical Center
Reading Pennsylvania, 19612, United States
Geisinger Medical Group
State College Pennsylvania, 16801, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre Pennsylvania, 18711, United States
CCOP - MainLine Health
Wynnewood Pennsylvania, 19096, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood Pennsylvania, 19096, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Medical X-Ray Center, PC
Sioux Falls South Dakota, 57105, United States
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls South Dakota, 57117, United States
MBCCOP - Meharry Medical College - Nashville
Nashville Tennessee, 37208, United States
CCOP - Scott and White Hospital
Temple Texas, 76508, United States
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay Wisconsin, 54301, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay Wisconsin, 54303, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay Wisconsin, 54303, United States
St. Vincent Hospital Regional Cancer Center
Green Bay Wisconsin, 54307, United States
Dean Medical Center - Fish Hatchery
Madison Wisconsin, 53715, United States
University of Wisconsin Comprehensive Cancer Center
Madison Wisconsin, 53792, United States
Holy Family Memorial Medical Center Cancer Care Center
Manitowoc Wisconsin, 54221, United States
Marshfield Clinic - Marshfield Center
Marshfield Wisconsin, 54449, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

282

Study ID:

NCT00060398

Recruitment Status:

Completed

Sponsor:


Eastern Cooperative Oncology Group

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.