Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer
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:
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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.
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Compare the effect of these regimens on increasing hemoglobin levels in these patients.
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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.
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Compare the survival rate of these regimens in these patients.
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Compare the toxicity profile of these regimens in these patients.
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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.
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Arm I: Patients receive epoetin alfa subcutaneously once a week.
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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
Outcome Measures
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 []
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Histologically confirmed prostate cancer
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Hormone-refractory disease as evidenced by progression on bone scan or CT scan with a rising prostate-specific antigen
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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
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Concurrent continual LHRH agonist therapy (e.g., depot leuprolide or goserelin) required for patients who have not undergone bilateral orchiectomy
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Must have anemia with hemoglobin ≥ 8 g/dL and < 12 g/dL within the past 14 days
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Must be iron replete (i.e., ferritin > 50 ng/mL) within the past 30 days
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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
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No disseminated intravascular coagulation
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No autoimmune hemolytic anemia
Hepatic
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AST and ALT ≤ 2 times upper limit of normal
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No prior hemochromatosis or iron intolerance
Renal
- Creatinine < 2.5 mg/dL
Cardiovascular
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Adequate blood pressure (i.e., systolic blood pressure < 140 mm Hg and diastolic blood pressure < 90 mm Hg) (treated or untreated)
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No history of thromboembolic events
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No unstable angina
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No poorly controlled cardiac disease
Other
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Fertile patients must use effective contraception
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Able to read, understand, and answer questions on the symptom and quality of life study instruments
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No ongoing chronic hemorrhage (e.g., gross hematuria due to advanced prostate cancer)* NOTE: *Microscopic hematuria allowed
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No acute or subacute illness that may require transfusion
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No gastrointestinal bleeding
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No active systemic infection
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No known or suspected hypersensitivity to human albumin
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No known or suspected hypersensitivity to mammalian cell-derived products
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No uncontrolled diabetes
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 30 days since prior epoetin alfa
Chemotherapy
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More than 21 days since prior chemotherapy
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No more than 2 different types of prior chemotherapy regimens for hormone-refractory prostate cancer
Endocrine therapy
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See Disease Characteristics
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More than 30 days since prior corticosteroids for hormone-refractory prostate cancer
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Episodic use of low-dose steroids for other causes is allowed
Radiotherapy
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More than 21 days since prior radiotherapy
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Concurrent radiotherapy allowed
Surgery
- See Disease Characteristics
Other
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More than 8 weeks since prior blood transfusion
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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.- CDR0000301881
- ECOG-E1Z01