Clinical Study of Epoetin Beta to Chemotherapy-Induced Anemia (CIA) Patients

A Phase Ⅲ Randomized Double-Blind Placebo-Controlled Study of Epoetin Beta for the Treatment of Chemotherapy-Induced Anemia (CIA) in Cancer Patients

This is a study to investigate the clinical efficacy and safety of epoetin beta 36,000 IU compared with placebo when administrated subcutaneously (s.c.) once-weekly for 12 weeks to anemic patients with lung cancer or gynecologic cancer undergoing chemotherapy.

Inclusion Criteria:

• Lung cancer or gynecologic cancer patients
• Undergoing platinum-based chemotherapy repeated for ≧ 2 cycles after erythropoietin (EPO) or placebo administration
• 8.0 g/dL ≦ hemoglobin concentration (Hb) ≦ 10.0 g/dL
• 20 - 79 years old
• Performance status: 0 - 2
• No iron deficiency anemia

Exclusion Criteria:

• Red blood cell transfusion within 4 weeks before treatment
• Erythropoietin therapy within 8 weeks before treatment