Breast Cancer Clinical Trial
Official title:
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
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