Not Signed In -
Ethinyl Estradiol and Norethindrone Acetate (Hormone Replacement Therapy) |
Femhrt |
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.
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:
- 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
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
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
Resources
- Ethinyl Estradiol and Norethindrone Acetate (Hormone Replacement Therapy) (Drug Digest)
- Femhrt (Drug Digest)
email this page
print this page
bookmark this page
feedback on this page
