A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

Inclusion Criteria: * Non-myeloid malignancy * At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule * Eastern Cooperative Oncology Group performance status of 0-2 * Hemoglobin concentration of less than 11 g/dL within 24 hours before randomization * Of legal age at the time written informed consent is obtained Exclusion Criteria: * Known history of seizure disorder * Known primary hematologic disorder, which could cause anemia, other than a non-myeloid malignancy * Unstable or uncontrolled disease/condition, related to or affecting cardiac function * Clinically significant inflammatory disease * Inadequate renal and/or liver function * Known positive HIV test * Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO * Received more than 2 red blood cell (RBC) transfusions within 4 weeks before randomization or any RBC transfusion within 14 days before randomization, or any planned RBC transfusion between randomization and study day 1 * Received any erythropoietic therapy within 4 weeks before randomization or any planned erythropoietic therapy between randomization and study day 1 * Other investigational procedures * Subject is currently enrolled in or less than 30 days since receipt of any investigational drug or device that is not approved by the applicable regulatory authority * Pregnant or breast feeding * Not using adequate contraceptive precautions * Known sensitivity to any of the products to be administered during dosing * Previously randomized in this study * Concerns for subject's compliance with protocol procedures