Epoetin Alfa in Treating Anemia in Patients Who Are Receiving Chemotherapy



Status:Completed
Conditions:Breast Cancer, Lung Cancer, Colorectal Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Lymphoma, Anemia, Hematology, Hematology, Hematology, Leukemia
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:7/14/2016
Start Date:December 1998
End Date:January 2010

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A Phase III Randomized Double-Blind Study of Erythropoietin Versus Placebo in Anemic Patients With Cancer Undergoing Chemotherapy

RATIONALE: Epoetin alfa may stimulate red blood cell production and treat anemia in patients
with cancer who are receiving chemotherapy. It is not yet known whether epoetin alfa is more
effective than a placebo in treating anemia in patients receiving chemotherapy.

PURPOSE: Randomized double blinded phase III trial to compare the effectiveness of epoetin
alfa with a placebo in treating anemia in cancer patients who are receiving chemotherapy.

OBJECTIVES: I. Determine whether epoetin alfa treatment improves the quality of life in
anemic patients who are undergoing chemotherapy for advanced malignancy. II. Determine
whether epoetin alfa increases hemoglobin levels and decreases transfusion requirements in
these patients. III. Validate or refute the use of an algorithm using pre- and posttreatment
epoetin alfa, ferritin, and hemoglobin levels to predict 16 weeks response or no response to
therapeutic doses of epoetin alfa as set forth by these patients. IV. Explore whether anemic
patients receiving platinum-containing chemotherapy regimens experience less nephrotoxicity
if they receive concurrent epoetin alfa compared to those who receive placebo.

OUTLINE: This is a randomized, double blind study. Patients are stratified by primary
malignant disease (lung vs breast vs other), life expectancy (4-6 months vs greater than 6
months), planned concurrent radiotherapy (yes vs no), and degree of anemia (mild or at least
9 g/dL vs severe or less than 9 g/dL). Patients receiving chemotherapy are randomized to
receive epoetin alfa subcutaneously once a week for a maximum of 16 weeks (arm I) or placebo
subcutaneously once a week for a maximum of 16 weeks (arm II). Quality of life is assessed
at randomization and monthly throughout study. Patients are followed every 6 months for 1
year.

DISEASE CHARACTERISTICS: Anemic: Hemoglobin in males less than 11.5 g/dL; hemoglobin in
females less than 10.0 g/dL No anemia secondary to B12, folic acid, or iron deficiency No
anemia secondary to gastrointestinal bleed or hemolysis No anemia secondary to a primary
or chemotherapy-induced myelodysplastic syndrome No anemia secondary to acute lymphocytic
leukemia Histologically confirmed advanced malignancy Lung Breast Other Currently
receiving myelosuppressive, cytotoxic chemotherapy for advanced cancer No patients
receiving adjuvant therapy for cancer that has been surgically removed

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At
least 4 months Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal:
Not specified Cardiovascular: No uncontrolled hypertension (systolic at least 180,
diastolic at least 100) Other: Normal or elevated ferritin No known hypersensitivity to
epoetin alfa Must be able to reliably take oral medication Must be alert and mentally
competent Not pregnant or nursing

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 year since prior epoetin alfa At
least 2 weeks since prior red blood cell transfusions No concurrent peripheral blood stem
cell or bone marrow transplantation Chemotherapy: See Disease Characteristics Endocrine
therapy: Not specified Radiotherapy: Concurrent radiotherapy allowed Surgery: See Disease
Characteristics
We found this trial at
21
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509 W. University Avenue
Urbana, Illinois 61801
(217) 383-3516
CCOP - Carle Cancer Center The Carle Cancer Center Community Clinical Oncology Program (CCOP) in...
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Bismarck, North Dakota 58501
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Cedar Rapids, Iowa 52403
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Danville, Pennsylvania 17822
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300 East Locust St., Ste 350
Des Moines, Iowa 50309
(515) 244-7586
CCOP - Iowa Oncology Research Association The Iowa Oncology Research Association (IORA) was established by...
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Des Moines, IA
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400 E Third Street
Duluth, Minnesota 55805
(218) 786-3868
CCOP - Duluth The Duluth CCOP, established and funded by the National Cancer Institute (NCI)...
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Fargo, North Dakota 58122
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Grand Forks, North Dakota 58201
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New Orleans, Louisiana 70121
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353 Fairmont Blvd
Rapid City, South Dakota 57701
(605) 719-1000
Rapid City Regional Hospital Regional Health is an integrated health care system of more than...
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Regina, Saskatchewan
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
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Saint Cloud, Minnesota 56303
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Scottsdale, Arizona 85259
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Sioux City, Iowa 51101
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Sioux Falls, South Dakota 57104
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Toledo, OH
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Washington, District of Columbia 20060
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Wichita, Kansas 67214
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