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