The Effect of Subcutaneous r-HuEPO in Patients With Chronic Anemia Secondary to Chemotherapy
Patients undergoing treatment with adriamycin-containing chemotherapy frequently develop
significant anemia. Agents that can increase the amount of hemoglobin in cancer patients
undergoing treatment with non-platinum-containing cyclic chemotherapy may improve the
patients' reduced physical strength and reduced stamina resulting from anemia, improve the
patients' ability to continue chemotherapy, and improve the patients' overall qualify of
life. Epoetin alfa is a genetically engineered form of a natural hormone, erythropoietin,
that is used to treat anemia by stimulating red blood cell production. This is a
randomized, double-blind, placebo-controlled, parallel group, multicenter study. The study
evaluates the safety and effectiveness of epoetin alfa in treating patients who develop
persistent anemia as a result of treatment with aggressive non-platinum-containing cyclic
chemotherapy for any cancer type (except rapid and severe onset of leukemias and
malignancies of the bone marrow and spleen). The study consists of a screening period when
patients' eligibility is determined, a 12-week double-blind treatment period when patients
receive 3 injections each week with either epoetin alfa or placebo, and an optional
open-label treatment period when patients who choose to continue will receive 3 injections
of epoetin alfa per week during any remaining cycles of their chemotherapy. Eligible
patients will be randomly assigned to one of two treatment groups: one group receiving
epoetin alfa 150 units/kilogram and the other group receiving a comparable volume of
placebo. Study drug is administered by injection beneath the skin 3 times weekly for 12
weeks. The dose of study medication may be increased or decreased at the discretion of the
physician, based on the results of blood tests. Depending on the patient's chemotherapy
cycle, he or she will return to the study site every 3 or 4 weeks for administration of
study medication. Safety evaluations (laboratory tests, vital sign measurements, reporting
of adverse events, physical examination, and electrocardiogram) are performed throughout the
study. The primary measures of effectiveness of the study drug will be determined by the
number of transfusions patients require and by changes in blood test results for hemoglobin,
hematocrit, and reticulocytes (immature red blood cells) from before the start of the study
to the end of the study. The study hypothesis is that epoetin alfa will, more effectively
than placebo, stimulate adequate production of red blood cells to increase the hemoglobin
level in cancer patients who are anemic as a result of undergoing treatment with aggressive
non-platinum-containing cyclic chemotherapy. Double-blind: Epoetin alfa 150 units/kilogram
(U/kg) or matching volume placebo injected beneath the skin 3 times weekly for 12 weeks.
Open-label: Epoetin alfa at the dose received at the end of the double-blind study injected
beneath the skin 3 times weekly for any remaining cycles of chemotherapy.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Number of transfusions; Change from baseline in levels of hemoglobin, hematocrit, reticulocytes (immature red blood cells)
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Study Director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
United States: Food and Drug Administration
CR005845
NCT00266617
June 1990
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