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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00060398
First received: May 6, 2003
Last updated: May 9, 2009
Last verified: July 2006
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Fatigue response as measured by the Functional Assessment of Chronic Illness Therapy Fatigue Subscale

Secondary Outcome Measures:
  • Anemia response at 3 months
  • Functional level as measured by the Functional Assessment of Cancer Therapy-General Scale and Brief Fatigue Inventory functional interference score monthly
  • Symptom distress as measured by the Memorial Symptom Assessment Scale-Short Form and the number of symptoms monthly
  • Quality of life as measured by the Functional Assessment of Cancer Therapy-General Scale monthly
  • Survival at 6 months
  • Adrenal suppression
  • Toxicity

Estimated Enrollment: 282
Study Start Date: June 2004
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060398

  Hide Study Locations
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
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
Porter Adventist Hospital
Denver, Colorado, United States, 80210
St. Joseph Hospital
Denver, Colorado, United States, 80218
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States, 80218
Rose Medical Center
Denver, Colorado, United States, 80220
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States, 80224-2522
Swedish Medical Center
Englewood, Colorado, United States, 80110
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, United States, 80502
St. Mary-Corwin Regional Medical Center
Pueblo, Colorado, United States, 81004
North Suburban Medical Center
Thorton, Colorado, United States, 80229
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
Winship Cancer Institute of Emory University
Altanta, Georgia, United States, 30322
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States, 30033
United States, Illinois
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
Hematology and Oncology Associates
Chicago, Illinois, United States, 60611
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, United States, 60611
Swedish Covenant Hospital
Chicago, Illinois, United States, 60625
Mercy Hospital and Medical Center
Chicago, Illinois, United States, 60616
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
St. Anthony's Memorial Hospital
Effingham, Illinois, United States, 62401
Elmhurst Memorial Hospital
Elmhurst, Illinois, United States, 60126
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States, 60521
Midwest Center for Hematology/Oncology
Joliet, Illinois, United States, 60432
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
North Shore Oncology and Hematology Associates, Limited - Libertyville
Libertyville, Illinois, United States, 60048
Northwest Medical Specialist, PC
Niles, Illinois, United States, 60714
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
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Iowa
McFarland Clinic, P. C.
Ames, Iowa, United States, 50010
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
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States, 50309
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
Mercy Capitol Hospital
Des Moines, Iowa, United States, 50307
Medical Oncology and Hematology Associates - West Des Moines
West Des Moines, Iowa, United States, 50266
United States, Kansas
Cancer Center of Kansas, P.A. - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
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
Southwest Medical Center
Liberal, Kansas, United States, 67901
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. - Salina
Salina, Kansas, United States, 67042
Cancer Center of Kansas, P.A. - Wellington
Wellington, Kansas, United States, 67152
Associates in Womens Health, P.A. - North Review
Wichita, Kansas, United States, 67203
Cancer Center of Kansas, P.A. - Wichita
Wichita, Kansas, United States, 67214
CCOP - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, P.A. - Medical Arts Tower
Wichita, Kansas, United States, 67208
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, P.A. - Winfield
Winfield, Kansas, United States, 67156
United States, Louisiana
Pennington Cancer Center at Baton Rouge General
Baton Rouge, Louisiana, United States, 70806
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, United States, 70809
Medical Center of Louisiana - New Orleans
New Orleans, Louisiana, United States, 70112
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Tufts - New England Medical Center
Boston, Massachusetts, United States, 02111
Lawrence Memorial Hospital of Medford
Medford, Massachusetts, United States, 02155
Commonwealth Hematology-Oncology P. C. - Quincy
Quincy, Massachusetts, United States, 02169
United States, Michigan
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123-2500
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
Foote Hospital
Jackson, Michigan, United States, 49201
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
Borgess Medical Center
Kalamazooaa, Michigan, United States, 49001
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48909
Seton Cancer Institute - Saginaw
Saginaw, Michigan, United States, 48601
St. John Macomb Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
MeritCare Clinic - Bemidji
Bemidji, Minnesota, United States, 56601
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
CCOP - Duluth
Duluth, Minnesota, United States, 55805
St. Mary's - Duluth Clinic Cancer Center
Duluth, Minnesota, United States, 55805
Miller-Dwan Medical Center
Duluth, Minnesota, United States, 55805
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale, Minnesota, United States, 55422-2900
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Health Services
St. Louis Park, Minnesota, United States, 55416
United Hospital
St. Paul, Minnesota, United States, 55102
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
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
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, United States, 44710-1799
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
CCOP - Columbus
Columbus, Ohio, United States, 43215
Doctors Hospital at Ohio Health
Columbus, Ohio, United States, 43228
Mount Carmel West Hospital
Columbus, Ohio, United States, 43222
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
Grant Riverside Cancer Services
Columbus, Ohio, United States, 43215
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States, 45505
Mercy Medical Center
Springfield, Ohio, United States, 45504
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
Westerville, Ohio, United States, 43081
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States, 43701
United States, Pennsylvania
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-0001
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301-1792
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141
Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
Geisinger Medical Group
State College, Pennsylvania, United States, 16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
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
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Dean Medical Center - Fish Hatchery
Madison, Wisconsin, United States, 53715
Holy Family Memorial Medical Center Cancer Care Center
Manitowoc, Wisconsin, United States, 54221-1450
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Shirley S. Hwang, RN, MS Veterans Affairs Medical Center - East Orange
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00060398     History of Changes
Other Study ID Numbers: CDR0000301881, ECOG-E1Z01
Study First Received: May 6, 2003
Last Updated: May 9, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent prostate cancer
anemia
fatigue

Additional relevant MeSH terms:
Prostatic Neoplasms
Anemia
Fatigue
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hematologic Diseases
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Epoetin alfa
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 19, 2014