A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up to Determine the Safety and Efficacy of r-HuEPO, Administered Subcutaneously, in Chronic Anemia Induced by Advanced Cancer
Patients with advanced cancer frequently develop significant anemia, as determined by a
blood test to measure hematocrit, with a below normal hematocrit of <=37%. Agents that can
elevate the hematocrit level in patients with advanced cancer may increase the physical
strength and stamina that is decreased by anemia, increase the patients' ability to
persevere with chemotherapy, and improve their overall quality 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 to determine the safety and
effectiveness of treatment with epoetin alfa in patients with persistent anemia caused by
advanced cancer. Eligible patients will be randomly assigned to one of two treatment
groups: epoetin alfa 100 units per kilogram or a comparable volume of placebo, given by
injection beneath the skin. Patients will be given study medication 3 times weekly for up
to 8 weeks or until a patient's hematocrit reaches 38% to 40%. The 8 weeks will be decreased
to 4 weeks if, by Week 4, a patient's hematocrit decreases by more than 15% from the start
of the study. At the end of the double-blind part of the study, patients who achieved a
hematocrit level of 38 to 40%, or whose hematocrit decreased by >=15% from the start of the
study by Week 4, will be allowed to enroll in the open-label part of the study for an
additional 6 months and will receive epoetin alfa at a dose adjusted to maintain a
hematocrit level between 38% and 40%. Within 5 to 7 days after it is documented that a
patient's hematocrit has reached 38% to 40%, epoetin alfa will then be given once weekly by
injection beneath the skin to maintain the hematocrit between 38% and 40% for the remaining
time of the study. Patients will be seen by a healthcare professional once weekly and by
the physician once monthly. Safety evaluations will include changes in laboratory tests,
vital signs, physical examinations, electrocardiograms, and the incidence of adverse events
from the start of the study to the end of the double-blind part of the study and to the end
of the open-label part of the study. Effectiveness will be assessed by blood transfusion
requirements and changes in hemoglobin, hematocrit, and immature red blood cell count from
the start of the study to the end of study, as well as the physician's global evaluation and
the quality of life assessment at the end of the double-blind part of the study and at the
end of the open-label part of the study. The study hypothesis is that epoetin alfa will be
well tolerated and more effective than placebo in stimulating adequate production of red
blood cells in patients who are anemic as a result of advanced cancer. Double-blind: Epoetin
alfa 100 units/kilogram (U/kg) or placebo injected under the skin; given 3 times weekly for
8 weeks or until hematocrit reaches 38%-40%. Open-label: Epoetin alfa 100 or 150 U/kg or a
higher dose injected under the skin on a schedule to maintain hematocrit of 38%-40%.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Changes in hemoglobin, hematocrit, and reticulocyte (immature red blood cells) count from before the study to the end of the study
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
CR005833
NCT00269984
June 1990
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