Clinical Trial: Epoetin alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer

This study is currently recruiting patients.

Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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: Randomized phase III trial to compare the effectiveness of epoetin alfa with or without dexamethasone in treating anemia-related fatigue in patients who have prostate cancer that is refractory to treatment with hormone therapy.

Condition Treatment or Intervention Phase
recurrent prostate cancer
Anemia
Fatigue
 Drug: dexamethasone
 Drug: epoetin alfa
 Procedure: biological response modifier therapy
 Procedure: colony-stimulating factor therapy
 Procedure: complications of therapy assessment/management
 Procedure: cytokine therapy
 Procedure: endocrine therapy
 Procedure: fatigue assessment/management
 Procedure: hormone therapy
 Procedure: steroid therapy
 Procedure: supportive care/therapy
Phase III

MedlinePlus related topics:  Anemia;   Prostate Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Epoetin alfa With or Without Dexamethasone for the Treatment of Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer

Further Study Details: 

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 above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

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


Location and Contact Information


Alabama
      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35294-3300,  United States; Recruiting
Carla I. Falkson, MD  205-975-2691    cfalkson@uab.edu 

Arizona
      CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States; Recruiting
Tom Robert Fitch, MD  480-301-9875 

California
      City of Hope Comprehensive Cancer Center, Duarte,  California,  91010-3000,  United States; Recruiting
Clinical Trials Office - New Patient Services  800-826-4673    becomingapatient@coh.org 

      Stanford Cancer Center at Stanford University Medical Center, Stanford,  California,  94305-5216,  United States; Recruiting
Harlan A. Pinto, MD  650-725-9057 

      Veterans Affairs Medical Center - Palo Alto, Palo Alto,  California,  94304-1290,  United States; Recruiting
Harlan A. Pinto, MD  650-493-5000 ext. 4948 

Colorado
      CCOP - Colorado Cancer Research Program, Incorporated, Denver,  Colorado,  80224,  United States; Recruiting
Eduardo R. Pajon, MD  303-777-2663    erpajon@aol.com 

Delaware
      CCOP - Christiana Care Health Services, Newark,  Delaware,  19713,  United States; Recruiting
Stephen Scott Grubbs, MD  302-623-4100 

District of Columbia
      MBCCOP - Howard University Cancer Center, Washington,  District of Columbia,  20060,  United States; Recruiting
Lucile L. Adams-Campbell, PhD  202-806-7697 

Florida
      H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa,  Florida,  33612,  United States; Recruiting
Cancer Answers  800-456-7121    canceranswers@moffitt.usf.edu 

      Veterans Affairs Medical Center - Gainesville, Gainesville,  Florida,  32608-1197,  United States; Recruiting
Dean Latain McCarley, MD  352-374-6016 

      Veterans Affairs Medical Center - Miami, Miami,  Florida,  33125,  United States; Recruiting
Niramol Savaraj, MD  305-575-3143    nsavaraj@med.miami.edu 

      Veterans Affairs Medical Center - Tampa (Haley), Tampa,  Florida,  33612,  United States; Recruiting
Julie A. Kish, MD, FACP  813-972-2000 

Georgia
      Veterans Affairs Medical Center - Atlanta (Decatur), Decatur,  Georgia,  30033,  United States; Recruiting
Maria Jose Amarante Ribeiro, MD  404-728-7680    maria.ribeiro@med.va.gov 

      Winship Cancer Institute of Emory University, Atlanta,  Georgia,  30322,  United States; Recruiting
William Costin Wood, MD  404-778-5180 

Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States; Recruiting
Kendrith M. Rowland, MD  217-383-4083    kendrith.rowland@carle.com 

      CCOP - Central Illinois, Decatur,  Illinois,  62526,  United States; Recruiting
James L. Wade, MD  217-876-6617    jlwade3@sbcglobal.net 

      CCOP - Evanston, Evanston,  Illinois,  60201,  United States; Recruiting
Gershon Y. Locker, MD, FACP  847-570-2518    glocker@enh.org 

      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61615-7828,  United States; Recruiting
John W. Kugler, MD  309-243-3605 

      Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago,  Illinois,  60611,  United States; Recruiting
Al Bowen Benson, MD, FACP  312-695-1382 

      Veterans Affairs Medical Center - Lakeside Chicago, Chicago,  Illinois,  60611-4494,  United States; Recruiting
Timothy M. Kuzel, MD  312-469-3748 

Indiana
      CCOP - Northern Indiana CR Consortium, South Bend,  Indiana,  46601,  United States; Recruiting
Rafat H. Ansari, MD, FACP  574-284-7977 

      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5289,  United States; Recruiting
Patrick J. Loehrer, MD  317-278-7418 

      Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis,  Indiana,  46202,  United States; Recruiting
Patrick J. Loehrer, MD  317-554-0000 

Iowa
      Burgess Health Center, Onawa,  Iowa,  51040,  United States; Recruiting
James A. Mailliard, MD  712-423-2311 

      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States; Recruiting
Martin Wiesenfeld, MD  319-363-8303 

      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States; Recruiting
Roscoe F. Morton, MD, FACP  515-244-7586 

      John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines,  Iowa,  50316-2301,  United States; Recruiting
Roscoe F. Morton, MD, FACP  515-663-5612 

      John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines,  Iowa,  50309,  United States; Recruiting
Roscoe F. Morton, MD, FACP  515-241-4245 

      Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines,  Iowa,  50314,  United States; Recruiting
Roscoe F. Morton, MD, FACP  515-247-3121 

Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States; Recruiting
Shaker R. Dakhil, MD, FACP  316-268-5784 

      Veterans Affairs Medical Center - Wichita, Wichita,  Kansas,  67218,  United States; Recruiting
Shaker R. Dakhil, MD, FACP  316-685-2221 

Louisiana
      CCOP - Ochsner, New Orleans,  Louisiana,  70121,  United States; Recruiting
Carl G. Kardinal, MD  504-842-3910 

      MBCCOP - LSU Health Sciences Center, New Orleans,  Louisiana,  70112,  United States; Recruiting
Jill Gilbert, MD  504-568-5613    jgilbe@lsuhsc.edu 

Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States; Recruiting
Michael Benjamin Atkins, MD  617-667-1930 

      Cancer Center at Tufts - New England Medical Center, Boston,  Massachusetts,  02111,  United States; Recruiting
John K. Erban, MD  617-636-5147    jerban@tufts-nemc.org 

Michigan
      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States; Recruiting
Raymond Sterling Lord, MD  269-373-7488    rlord@wmcc.org 

      CCOP - Michigan Cancer Research Consortium, Ann Arbor,  Michigan,  48106,  United States; Recruiting
Philip J. Stella, MD  734-712-5237 

Minnesota
      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States; Recruiting
Robert J. Dalton, MD  218-786-8364    rdalton@smdc.org 

      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States; Recruiting
Patrick J. Flynn, MD  952-993-1517    patrick.flynn@usoncology.com 

      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States; Recruiting
Thomas M. Habermann, MD  507-284-2511 

      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States; Recruiting
George L. Adams, MD  612-625-2410    adams002@umn.edu 

      Veterans Affairs Medical Center - Minneapolis, Minneapolis,  Minnesota,  55417-2399,  United States; Recruiting
Markus Gapany, MD, FACS  612-725-2000 ext. 3459    gapan001@maroon.tc.umn.edu 

Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States; Recruiting
James A. Mailliard, MD  402-280-4364    jamailliard@mrcc.cc 

      Midlands Cancer Center at Midlands Community Hospital, Papillion,  Nebraska,  68128-4157,  United States; Recruiting
James A. Mailliard, MD  402-593-3000 

      Veterans Affairs Medical Center - Omaha, Omaha,  Nebraska,  68105,  United States; Recruiting
James A. Mailliard, MD  402-280-5274 

Nevada
      CCOP - Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  United States; Recruiting
John Allan Ellerton, MD, CM  702-384-0013    k.vanwagenen@sncrf.org 

New Hampshire
      Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon,  New Hampshire,  03756-0002,  United States; Recruiting
Camilo E. Fadul, MD  603-650-6312    Camilo.e.fadul@dartmouth.edu 

New Jersey
      Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick,  New Jersey,  08903,  United States; Recruiting
Joseph Aisner, MD  732-235-7401    aisnerjo@umdnj.edu 

      CCOP - Northern New Jersey, Hackensack,  New Jersey,  07601,  United States; Recruiting
Richard J. Rosenbluth, MD  201-996-5917 

      Veterans Affairs Medical Center - East Orange, East Orange,  New Jersey,  07018,  United States; Recruiting
Basil S. Kasimis, MD, DSc  973-676-1000 ext. 7095    Basil.Kasimis@med.va.gov 

New Mexico
      MBCCOP - University of New Mexico HSC, Albuquerque,  New Mexico,  87131,  United States; Recruiting
Cynthia K. Cathcart, MD  505-272-5688 

New York
      Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx,  New York,  10461,  United States; Recruiting
Joseph A. Sparano, MD  718-904-2555    jsparano@montefiore.org 

      MBCCOP-Our Lady of Mercy Cancer Center, Bronx,  New York,  10466,  United States; Recruiting
Peter H. Wiernik, MD  718-920-9900    pwiernik@olmhs.org 

      NYU Cancer Institute at New York University Medical Center, New York,  New York,  10016,  United States; Recruiting
Howard S. Hochster, MD  212-731-5100    howard.hochster@med.nyu.edu 

      Veterans Affairs Medical Center - Brooklyn, Brooklyn,  New York,  11209,  United States; Recruiting
Andrea Nadine Wiesel Leaf, MD  718-630-3691 

      Veterans Affairs Medical Center - New York, New York,  New York,  10010,  United States; Recruiting
Howard S. Hochster, MD  212-652-1912    howard.hochster@med.nyu.edu 

North Dakota
      CCOP - Merit Care Hospital, Fargo,  North Dakota,  58122,  United States; Recruiting
Preston D. Steen, MD  701-234-6298    prestonsteen@meritcare.com 

Ohio
      CCOP - Columbus, Columbus,  Ohio,  43206,  United States; Recruiting
J. Philip Kuebler, MD, PhD  614-488-2118 

      CCOP - Toledo Community Hospital, Toledo,  Ohio,  43623-3456,  United States; Recruiting
Paul L. Schaefer, MD  419-843-6147 

      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States; Recruiting
Robert Dreicer, MD, FACP  216-445-4623 

      MetroHealth's Cancer Care Center at MetroHealth Medical Center, Cleveland,  Ohio,  44109,  United States; Recruiting
Edward G. Mansour, MD  216-778-4394    emansour@metrohealth.org 

Oklahoma
      CCOP - Oklahoma, Tulsa,  Oklahoma,  74136,  United States; Recruiting
James B. Lockhart, MD  918-491-5878 

Pennsylvania
      Abramson Cancer Center at the University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
Daniel G. Haller, MD  215-662-6318 

      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States; Recruiting
Albert M. Bernath, MD  570-271-6466 

      CCOP - MainLine Health, Wynnewood,  Pennsylvania,  19096,  United States; Recruiting
Paul B. Gilman, MD  610-645-2494 

      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111-2497,  United States; Recruiting
Lori J. Goldstein, MD  215-728-2689    lj_goldstein@fccc.edu 

      Hahnemann University Hospital, Philadelphia,  Pennsylvania,  19102-1192,  United States; Recruiting
Pamela Ann Crilley, DO  215-762-8547 

      Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15236,  United States; Recruiting
John Munn Kirkwood, MD  412-692-4724 

      Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033-0850,  United States; Recruiting
Witold Boleslaw Rybka, MD, FRCPC  717-531-1050    wrybka@med.hmc.psu.edu 

      Veterans Affairs Medical Center - Pittsburgh, Pittsburgh,  Pennsylvania,  15240,  United States; Recruiting
Timothy Carlos, MD  412-688-6248    timothy.carlos@med.va.gov 

South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57104,  United States; Recruiting
Loren K. Tschetter, MD  605-328-8044    tidemanb@siouxvalley.org 

Tennessee
      Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville,  Tennessee,  37232-6307,  United States; Recruiting
David Horton Johnson, MD  615-343-9454    david.h.johnson@vanderbilt.edu 

      Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus, Nashville,  Tennessee,  37212-2637,  United States; Recruiting
Kenneth R. Hande, MD  615-327-4751 

Texas
      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States; Recruiting
Lucas Wong, MD  254-724-1053    lwong@swmail.sw.org 

Wisconsin
      CCOP - Marshfield Clinic Research Foundation, Marshfield,  Wisconsin,  54449,  United States; Recruiting
Tarit Kumar Banerjee, MD, FACP  715-387-5511 

      CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay,  Wisconsin,  54301,  United States; Recruiting
Gerald K. Bayer, MD  920-433-8889 

      Medical College of Wisconsin Cancer Center, Milwaukee,  Wisconsin,  53226-3596,  United States; Recruiting
David H. Vesole, MD, PhD  414-805-4626    dvesole@bmt.mcw.edu 

      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-0001,  United States; Recruiting
James A. Stewart, MD  608-265-8131    stewart@biostat.wisc.edu 

      Veterans Affairs Medical Center - Madison, Madison,  Wisconsin,  53705,  United States; Recruiting
Mark R. Albertini, MD  608-262-7017 

      Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee,  Wisconsin,  53295,  United States; Recruiting
Mohammed A. Raheem, MD  414-384-2000 

Australia, New South Wales
      Westmead Breast Centre at NSW Breast Cancer Institute, Westmead,  New South Wales,  2145,  Australia; Recruiting
Michael B. Barton, MD  61-2-9845-5555    barton@radonc.ish.su.edu 

      Westmead Hospital, Westmead,  New South Wales,  2145,  Australia; Recruiting
Richard Kefford, MD, PhD  61-2-9845-6033 

Peru
      Instituto de Enfermedades Neoplasicas, Lima,  34,  Peru; Recruiting
Carlos Santiago Vallejos-Sologuren, MD  51-14-499-137    postmaster@inen.sld.pe 

Puerto Rico
      MBCCOP - San Juan, San Juan,  00921-3201,  Puerto Rico; Recruiting
Luis Baez-Diaz, MD  787-641-3693    sjccop@prtc.net 

      San Juan City Hospital, San Juan,  00936-7344,  Puerto Rico; Recruiting
Luis Baez-Diaz, MD  787-641-3693    sjccop@prtc.net 

      Veterans Affairs Medical Center - San Juan, San Juan,  00927-5800,  Puerto Rico; Recruiting
Luis Baez-Diaz, MD  787-641-7582    sjccop@prtc.net 

South Africa
      Pretoria Academic Hospital, Pretoria,  0001,  South Africa; Recruiting
Coenraad Frederick Slabber, MD  27-12-354-1054 

Study chairs or principal investigators

Shirley S. Hwang, RN, MS,  Study Chair,  Veterans Affairs Medical Center - East Orange   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000301881; ECOG-E1Z01; NCT00060398
Record last reviewed:  July 2004
Last Updated:  April 4, 2005
Record first received:  May 6, 2003
ClinicalTrials.gov Identifier:  NCT00060398
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005