Treatment for Patients With Non-Myeloid Malignancies Receiving Chemotherapy

A Randomized, Open Label Study to Assess Time to Hemoglobin Response of a Front Load Dosing Regimen for Darbepoetin Alfa Compared to a Weekly Dose Regimen for Recombinant Human Erythropoietin in Patients With Non-Myeloid Malignancies Receiving Chemotherapy

The purpose of this study is to compare the time to hematopoietic response (hemoglobin correction to 12 g/dL or a greater than or equal to 2 g/dL increase from baseline) for subjects randomized to receive darbepoetin alfa with a front load dosing regimen to those receiving recombinant human erythropoietin (rHuEPO) with a weekly dose regimen during the 12-week comparative treatment period.

Inclusion Criteria:

• Subjects with non-myeloid malignancies planning to receive cyclic chemotherapy for 8 additional weeks or more
• Anemia (hemoglobin [hgb] greater than or equal to 9.0g/dL and less than or equal to 11.0 g/dL) related to cancer and chemotherapy
• Karnofsky performance status of greater than or equal to 50%
• Serum bilirubin less than or equal to 2.5 times the upper limit of normal range and serum creatinine concentration of less than or equal to 2.0 mg/dL

Exclusion Criteria:

• Acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), or myelodysplastic syndromes
• Hematologic disorder previously associated with anemia
• Active bleeding
• Iron deficiency
• Received erythropoietic therapy within 14 days prior to randomization
• Unstable cardiac disease
• Known positive human immunodeficiency virus antibody or hepatitis B surface antigen
• Known positive antibody response to any erythropoietic agent
• Currently enrolled in, or has not yet completed at least 30 days since ending other investigational device or drug trial or is receiving investigational agent(s) not approved for any indication
• Pregnant or breast feeding
• Red blood cell (RBC) transfusion within 4 weeks of screening
• Known hypersensitivity to any recombinant mammalian-derived product