Trial Information

An Open-label, Randomized Study to Evaluate the Effect of Early Treatment of Anemia With Epoetin Alfa on Hemoglobin, the Incidence of Blood Transfusions and Quality of Life in Patients Receiving Platinum-containing 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 epoetin alfa increases hemoglobin and
reduces the incidence of red blood cell transfusions and that achieving a higher hemoglobin
level may improve quality of life. This is a randomized, open-label, multicenter study that
evaluates the effects of early treatment with epoetin alfa compared with standard anemia
care alone to determine its impact on the need for blood transfusions, tumor response,
anemia and quality of life, as well as on the safety of epoetin alfa when used in the
prevention of anemia during chemotherapy in adult patients with cancer. Patients will
receive epoetin alfa injections (10,000 units) under the skin 3 times a week until 4 weeks
after the last day of the last chemotherapy cycle, in addition to best standard care, or
best standard care alone. Best standard care during chemotherapy may include red blood cell
transfusions, white cell growth factors, and iron supplementation, as needed. The dose of
epoetin alfa may be adjusted up (to 20,000 units) or down (to 75% of the last dose) based on
hemoglobin level.

The primary measure of effectiveness will be determined by the number of patients who
receive an allogenic red blood cell transfusion during the study and during each
chemotherapy cycle. Additional measures of effectiveness include: the average number of
units transfused during each cycle, change in quality of life (feeling of well-being, as
assessed by responses to 3 different patient questionnaires), change in hemoglobin level,
relationship between change in hemoglobin and quality of life, tumor response, and the
number of patients surviving up to 12 months after the end of treatment. Safety evaluations
(incidence of adverse events, clinical laboratory tests, vital signs, and physical
examinations) will be performed throughout the study. The study hypothesis is that treatment
with epoetin alfa will reduce the need for red blood cell transfusions, increase hemoglobin
levels, improve quality of life, and result in a positive tumor response in patients with
cancer who are receiving chemotherapy. This study will be conducted in the Netherlands and
will only enroll European patients. Patients will receive epoetin alfa injections (10,000
units) under the skin 3 times a week until 4 weeks after the last day of the last
chemotherapy cycle, or best standard care. Dose may be adjusted up (to 20,000 units) or down
(to 75% of the last dose) based on hemoglobin level.