Randomised Study to Evaluate the Effect of Early Intervention to Treat Anemia With Epoetin Alfa Versus Standard Use on Hemoglobin Levels and the Incidence of Blood Transfusions in Cancer Patients Receiving Chemotherapy
Cancer patients often experience anemia due to the disease itself, chemotherapy, or both.
Quality of life is also affected, due in part to the tiredness associated with anemia.
Previous studies with epoetin alfa have suggested that early intervention with epoetin alfa
results in higher hemoglobin levels and lower incidence of red blood cell transfusions than
are achieved with delayed intervention. This is a randomized, open-label, explorative,
sequential study that evaluates the effects of early treatment with epoetin alfa to
determine its impact on hemoglobin values and the need for red blood cell transfusions as
well as the safety of epoetin alfa when used in the prevention of anemia during chemotherapy
in adult patients with cancer. During their current course of chemotherapy, patients will
receive either early treatment with epoetin alfa or standard treatment with epoetin alfa
(epoetin alfa administered when hemoglobin is <=10 g/dL), in addition to best standard care.
Best standard care during chemotherapy may include red blood cell transfusions, white cell
growth factors, folic acid, and iron supplementation, as needed. Effectiveness will be
determined by the number of patients who receive an allogenic blood transfusion during the
study and the change in hemoglobin at 3 or 4 weeks, 8 or 9 weeks, and 12 weeks, and at the
end of the treatment period. Safety evaluations (incidence of adverse events, abnormal
clinical laboratory tests, and vital signs) will be performed throughout the study. The
study hypothesis is that cancer patients receiving chemotherapy who receive early treatment
with epoetin alfa will have higher hemoglobin levels and fewer red blood cell transfusions
than cancer patients receiving chemotherapy who receive standard treatment with epoetin
alfa. This study will be conducted in the Netherlands and will only enroll European patients
and will be generally well-tolerated. Epoetin alfa injections (40,000 units) under skin once
a week either within 7 days after start of first chemotherapy cycle or from day hemoglobin
is <=10 g/dL. Patients will receive epoetin alfa during the current course of chemotherapy
or up to 24 weeks. Dose may be adjusted.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Change in hemoglobin from the start of the study to 3 or 4, 8 or 9, and 12 weeks, and at the end of the treatment period
Janssen-Cilag B.V. Clinical Trial
Netherlands: Netherlands Medicines Evaluation Board