Trial Information

The Effect of Subcutaneous r-HuEPO in Patients With Chronic Anemia Secondary to Cisplatin Chemotherapy

Patients undergoing treatment with cisplatin-containing chemotherapy frequently develop
significant anemia (hemoglobin <= 10.5 grams/deciliter). Agents that can increase the
amount of hemoglobin in cancer patients undergoing treatment with cisplatin-containing
cyclic chemotherapy may improve the patients' reduced physical strength and reduced stamina
resulting from anemia, increase 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. This study evaluates the safety and effectiveness of epoetin alfa in
treating patients who develop persistent anemia as a result of treatment with aggressive
cisplatin-containing cyclic chemotherapy (every 3 to 4 weeks) for any cancer type (except
rapid and severe onset of leukemias and malignancies of the bone marrow and spleen). The
study consists of a <= 7 day screening period when patients' eligibility is determined, a
12-week double-blind treatment period, and an optional open-label treatment period.
Eligible patients will be randomly assigned to one of two treatment groups: epoetin alfa 150
units/kilogram or a comparable volume of placebo, given by injection beneath the skin.
Patients will be treated with study medication 3 times weekly for 12 weeks. Two of the 3
weekly doses of study medication may be self-administered by the patient at home; the
patient is visited by a health professional at least once weekly to administer the other
dose(s). 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. During the open-label treatment period, patients who choose to continue
will receive 3 injections per week of epoetin alfa under the skin, until the completion of
his or her chemotherapy treatments. Safety evaluations, including laboratory tests, vital
signs, reporting of adverse events, physical examination, and electrocardiograms, are
performed throughout the study. Effectiveness of the study drug will be determined by the
number of transfusions patients require and by changes in blood test results (hemoglobin,
hematocrit, and 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 elevate the hemoglobin level in cancer
patients who are anemic as a result of undergoing treatment with aggressive
cisplatin-containing cyclic chemotherapy. Double-blind: Epoetin alfa 150 units/kilogram, or
matching volume of 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.