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
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