Study of Darbepoetin Alfa for the Treatment of Anemia of Cancer

Inclusion Criteria: * subjects with non-myeloid malignancies * anemia due to cancer * ECOG status 0 to 2 * greater than or equal to 4-month expectancy * greater than or equal to 18 years and of legal age for informed consent * screening hemoglobin concentration less than or equal to 11.0g/dL * adequate serum folate and vitamin B12 * adequate renal and liver function * written informed consent Exclusion Criteria: * subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy during the study or within 4 weeks before randomization * in complete remission, as determined by the investigator * subjects who have other diagnoses not related to the cancer which cause anemia (eg. gastrointestinal bleeding, renal disease, etc) * documented history of pure red cell aplasia * Known history of seizure disorder * cardiac condition: uncontrolled angina, congestive heart failure, known ejection fraction less than 40%, or uncontrolled cardiac arrhythmia * uncontrolled hypertension * clinically significant systemic infection or chronic inflammatory disease present at the time of randomization * iron deficiency * known positive test for HIV infection * previously suspected of or confirmed to have neutralizing antibodies to rHuEPO or darbepoetin alfa * received rHuEPO or darbepoetin alfa therapy within 4 weeks of randomization * 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 * subject of reproductive potential who is not using adequate contraceptive precautions * known hypersensitivity to mammalian-derived product or any other ingredients in the investigational product * previously randomized into this study * concerns for subject's compliance with the protocol procedures