Treatment for Patients With Non-Myeloid Malignancies Receiving Chemotherapy

• Exploratory analyses for other patient reported outcome scales collected during the study (FACT-Anemia, BSI, EQ-5D, and Patient Satisfaction Questionnaire for Injectable Anemia Treatment) [ Time Frame: during the study ] [ Designated as safety issue: No ]
• Incidence, if any, of neutralizing antibody formation to study drug [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
• Difference between the average hemoglobin after the first month of treatment compared to the baseline hemoglobin [ Time Frame: baseline to first month of treatment ] [ Designated as safety issue: No ]
• Time to 2 g/dL increase in hemoglobin during the comparative treatment period [ Time Frame: during the comparative treatment period ] [ Designated as safety issue: No ]
• Change in FACT-Fatigue scale score over time during the comparative treatment period [ Time Frame: during the comparative treatment period ] [ Designated as safety issue: No ]
• Overall incidence of adverse events, serious adverse events and related adverse events as measured throughout study [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
• Slope of change in hemoglobin after the first month of treatment [ Time Frame: baseline to first month of treatment ] [ Designated as safety issue: No ]
• Red blood cell usage during the treatment period and other changes in hemoglobin during the comparative treatment period [ Time Frame: during the comparative treatment period ] [ Designated as safety issue: No ]
• Changes in hemoglobin during the maintenance period [ Time Frame: during the maintenance period ] [ Designated as safety issue: No ]

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.

• Cancer
• Non-Myeloid Malignancies

• Drug: rHuEPO
  rHuEPO 40,000U QW for 4 weeks. Dose will be increased to 60,000U/week at week 5 if inadequate response through week 12.
• Drug: Darbepoetin alfa
  4.5 mcg/kg QW for 4 weeks then Q3W starting at week 5 through week 11.

• Active Comparator: rHuEPO
  Intervention: Drug: rHuEPO
• Experimental: Darbepoetin alfa
  Intervention: Drug: Darbepoetin alfa

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