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

Sponsor
Eastern Cooperative Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00060398
Collaborator
National Cancer Institute (NCI) (NIH)
282
140
2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
282 participants
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
Study Start Date :
Jun 1, 2004
Actual Primary Completion Date :
Jun 1, 2006

Outcome Measures

Primary Outcome Measures

  1. Fatigue response as measured by the Functional Assessment of Chronic Illness Therapy Fatigue Subscale []

Secondary Outcome Measures

  1. Anemia response at 3 months []

  2. Functional level as measured by the Functional Assessment of Cancer Therapy-General Scale and Brief Fatigue Inventory functional interference score monthly []

  3. Symptom distress as measured by the Memorial Symptom Assessment Scale-Short Form and the number of symptoms monthly []

  4. Quality of life as measured by the Functional Assessment of Cancer Therapy-General Scale monthly []

  5. Survival at 6 months []

  6. Adrenal suppression []

  7. Toxicity []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 120 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Memorial Medical Center Cancer Services Modesto California United States 95355
2 Aurora Presbyterian Hospital Aurora Colorado United States 80012
3 Boulder Community Hospital Boulder Colorado United States 80301-9019
4 Penrose Cancer Center at Penrose Hospital Colorado Springs Colorado United States 80933
5 Porter Adventist Hospital Denver Colorado United States 80210
6 Presbyterian - St. Luke's Medical Center Denver Colorado United States 80218
7 St. Joseph Hospital Denver Colorado United States 80218
8 Rose Medical Center Denver Colorado United States 80220
9 CCOP - Colorado Cancer Research Program, Incorporated Denver Colorado United States 80224-2522
10 Swedish Medical Center Englewood Colorado United States 80110
11 Sky Ridge Medical Center Lone Tree Colorado United States 80124
12 Hope Cancer Care Center at Longmont United Hospital Longmont Colorado United States 80502
13 St. Mary-Corwin Regional Medical Center Pueblo Colorado United States 81004
14 North Suburban Medical Center Thornton Colorado United States 80229
15 H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Tampa Florida United States 33612-9497
16 Winship Cancer Institute of Emory University Atlanta Georgia United States 30322
17 Veterans Affairs Medical Center - Atlanta (Decatur) Decatur Georgia United States 30033
18 Rush-Copley Cancer Care Center Aurora Illinois United States 60507
19 Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago Illinois United States 60611-3013
20 Hematology and Oncology Associates Chicago Illinois United States 60611
21 Veterans Affairs Medical Center - Lakeside Chicago Chicago Illinois United States 60611
22 Mercy Hospital and Medical Center Chicago Illinois United States 60616
23 Swedish Covenant Hospital Chicago Illinois United States 60625
24 St. Anthony's Memorial Hospital Effingham Illinois United States 62401
25 Elmhurst Memorial Hospital Elmhurst Illinois United States 60126
26 Hinsdale Hematology Oncology Associates Hinsdale Illinois United States 60521
27 Midwest Center for Hematology/Oncology Joliet Illinois United States 60432
28 Joliet Oncology-Hematology Associates, Limited - West Joliet Illinois United States 60435
29 North Shore Oncology and Hematology Associates, Limited - Libertyville Libertyville Illinois United States 60048
30 Northwest Medical Specialist, PC Niles Illinois United States 60714
31 Hematology/Oncology of the North Shore at Gross Point Medical Center Skokie Illinois United States 60076
32 Midwest Cancer Research Group, Incorporated Skokie Illinois United States 60077
33 Carle Cancer Center at Carle Foundation Hospital Urbana Illinois United States 61801
34 CCOP - Carle Cancer Center Urbana Illinois United States 61801
35 McFarland Clinic, P. C. Ames Iowa United States 50010
36 Mercy Capitol Hospital Des Moines Iowa United States 50307
37 CCOP - Iowa Oncology Research Association Des Moines Iowa United States 50309
38 John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines Iowa United States 50309
39 Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines Iowa United States 50309
40 Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines Iowa United States 50314
41 Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
42 John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines Iowa United States 50316-2301
43 Medical Oncology and Hematology Associates - West Des Moines West Des Moines Iowa United States 50266
44 Cancer Center of Kansas, P.A. - Chanute Chanute Kansas United States 66720
45 Cancer Center of Kansas, PA - Dodge City Dodge City Kansas United States 67801
46 Cancer Center of Kansas, P.A. - El Dorado El Dorado Kansas United States 67042
47 Cancer Center of Kansas, P.A. - Kingman Kingman Kansas United States 67068
48 Southwest Medical Center Liberal Kansas United States 67901
49 Cancer Center of Kansas, P.A. - Newton Newton Kansas United States 67114
50 Cancer Center of Kansas, P.A. - Parsons Parsons Kansas United States 67357
51 Cancer Center of Kansas, P.A. - Pratt Pratt Kansas United States 67124
52 Cancer Center of Kansas, P.A. - Salina Salina Kansas United States 67042
53 Cancer Center of Kansas, P.A. - Wellington Wellington Kansas United States 67152
54 Associates in Womens Health, P.A. - North Review Wichita Kansas United States 67203
55 Cancer Center of Kansas, P.A. - Medical Arts Tower Wichita Kansas United States 67208
56 Cancer Center of Kansas, P.A. - Wichita Wichita Kansas United States 67214
57 CCOP - Wichita Wichita Kansas United States 67214
58 Via Christi Cancer Center at Via Christi Regional Medical Center Wichita Kansas United States 67214
59 Cancer Center of Kansas, P.A. - Winfield Winfield Kansas United States 67156
60 Pennington Cancer Center at Baton Rouge General Baton Rouge Louisiana United States 70806
61 Mary Bird Perkins Cancer Center - Baton Rouge Baton Rouge Louisiana United States 70809
62 MBCCOP - LSU Health Sciences Center New Orleans Louisiana United States 70112
63 Medical Center of Louisiana - New Orleans New Orleans Louisiana United States 70112
64 Tufts - New England Medical Center Boston Massachusetts United States 02111
65 Lawrence Memorial Hospital of Medford Medford Massachusetts United States 02155
66 Commonwealth Hematology-Oncology P. C. - Quincy Quincy Massachusetts United States 02169
67 St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital Ann Arbor Michigan United States 48106-0995
68 CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan United States 48106
69 Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn Michigan United States 48123-2500
70 Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods Michigan United States 48236
71 Foote Hospital Jackson Michigan United States 49201
72 Borgess Medical Center Kalamazoo Michigan United States 49001
73 West Michigan Cancer Center Kalamazoo Michigan United States 49007-3731
74 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
75 Sparrow Regional Cancer Center Lansing Michigan United States 48909
76 Seton Cancer Institute - Saginaw Saginaw Michigan United States 48601
77 St. John Macomb Hospital Warren Michigan United States 48093
78 MeritCare Clinic - Bemidji Bemidji Minnesota United States 56601
79 Fairview Ridges Hospital Burnsville Minnesota United States 55337
80 Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids Minnesota United States 55433
81 CCOP - Duluth Duluth Minnesota United States 55805
82 Miller-Dwan Medical Center Duluth Minnesota United States 55805
83 St. Mary's - Duluth Clinic Cancer Center Duluth Minnesota United States 55805
84 Fairview Southdale Hospital Edina Minnesota United States 55435
85 Mercy and Unity Cancer Center at Unity Hospital Fridley Minnesota United States 55432
86 Virginia Piper Cancer Institute at Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
87 Hubert H. Humphrey Cancer Center at North Memorial Medical Center Robbinsdale Minnesota United States 55422-2900
88 CCOP - Metro-Minnesota Saint Louis Park Minnesota United States 55416
89 Park Nicollet Health Services Saint Louis Park Minnesota United States 55416
90 United Hospital Saint Paul Minnesota United States 55102
91 Ridgeview Medical Center Waconia Minnesota United States 55387
92 University Medical Center of Southern Nevada Las Vegas Nevada United States 89102
93 CCOP - Nevada Cancer Research Foundation Las Vegas Nevada United States 89106
94 Veterans Affairs Medical Center - East Orange East Orange New Jersey United States 07018-1095
95 Fox Chase Virtua Health Cancer Program - Marlton Marlton New Jersey United States 08053
96 Shore Memorial Hospital - Somers Point Somers Point New Jersey United States 08244
97 Fox Chase Virtua Health Cancer Program at Virtua West Jersey Voorhees New Jersey United States 08043
98 Albert Einstein Cancer Center at Albert Einstein College of Medicine Bronx New York United States 10461
99 Our Lady of Mercy Medical Center Comprehensive Cancer Center Bronx New York United States 10466
100 CCOP - MeritCare Hospital Fargo North Dakota United States 58122
101 MeritCare Medical Group Fargo North Dakota United States 58122
102 Aultman Hospital Cancer Center at Aultman Health Foundation Canton Ohio United States 44710-1799
103 Adena Regional Medical Center Chillicothe Ohio United States 45601
104 Case Comprehensive Cancer Center Cleveland Ohio United States 44106
105 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
106 Riverside Methodist Hospital Cancer Care Columbus Ohio United States 43214-3998
107 CCOP - Columbus Columbus Ohio United States 43215
108 Grant Riverside Cancer Services Columbus Ohio United States 43215
109 Mount Carmel West Hospital Columbus Ohio United States 43222
110 Doctors Hospital at Ohio Health Columbus Ohio United States 43228
111 Grady Memorial Hospital Delaware Ohio United States 43015
112 Fairfield Medical Center Lancaster Ohio United States 43130
113 Strecker Cancer Center at Marietta Memorial Hospital Marietta Ohio United States 45750
114 Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark Ohio United States 43055
115 Mercy Medical Center Springfield Ohio United States 45504
116 Community Hospital of Springfield and Clark County Springfield Ohio United States 45505
117 Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital Westerville Ohio United States 43081
118 Genesis - Good Samaritan Hospital Zanesville Ohio United States 43701
119 Bryn Mawr Hospital Bryn Mawr Pennsylvania United States 19010
120 Geisinger Medical Center Danville Pennsylvania United States 17822-0001
121 Paoli Memorial Hospital Paoli Pennsylvania United States 19301-1792
122 Albert Einstein Cancer Center Philadelphia Pennsylvania United States 19141
123 Reading Hospital and Medical Center Reading Pennsylvania United States 19612-6052
124 Geisinger Medical Group State College Pennsylvania United States 16801
125 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre Pennsylvania United States 18711
126 CCOP - MainLine Health Wynnewood Pennsylvania United States 19096
127 Lankenau Cancer Center at Lankenau Hospital Wynnewood Pennsylvania United States 19096
128 Avera Cancer Institute Sioux Falls South Dakota United States 57105
129 Medical X-Ray Center, PC Sioux Falls South Dakota United States 57105
130 Sioux Valley Hospital and University of South Dakota Medical Center Sioux Falls South Dakota United States 57117-5039
131 MBCCOP - Meharry Medical College - Nashville Nashville Tennessee United States 37208-3599
132 CCOP - Scott and White Hospital Temple Texas United States 76508
133 Green Bay Oncology, Limited at St. Vincent Hospital Green Bay Wisconsin United States 54301-3526
134 Green Bay Oncology, Limited at St. Mary's Hospital Green Bay Wisconsin United States 54303
135 St. Mary's Hospital Medical Center - Green Bay Green Bay Wisconsin United States 54303
136 St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin United States 54307-3508
137 Dean Medical Center - Fish Hatchery Madison Wisconsin United States 53715
138 University of Wisconsin Comprehensive Cancer Center Madison Wisconsin United States 53792-6164
139 Holy Family Memorial Medical Center Cancer Care Center Manitowoc Wisconsin United States 54221-1450
140 Marshfield Clinic - Marshfield Center Marshfield Wisconsin United States 54449

Sponsors and Collaborators

  • Eastern Cooperative Oncology Group
  • National Cancer Institute (NCI)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00060398
Other Study ID Numbers:
  • CDR0000301881
  • ECOG-E1Z01
First Posted:
May 7, 2003
Last Update Posted:
Feb 3, 2021
Last Verified:
Jul 1, 2006
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 3, 2021