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 |
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.
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.
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
sites
CCOP - Carle Cancer Center The Carle Cancer Center Community Clinical Oncology Program (CCOP) in...
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300 East Locust St., Ste 350
Des Moines, Iowa 50309
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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CCOP - Duluth The Duluth CCOP, established and funded by the National Cancer Institute (NCI)...
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Rapid City Regional Hospital Regional Health is an integrated health care system of more than...
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Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
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