Darbepoetin Alfa Compared With Epoetin Alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer

OBJECTIVES:

Primary

• Compare the efficacy of darbepoetin alfa vs epoetin alfa for anemia in patients with non-myeloid malignancies receiving chemotherapy.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to screening hemoglobin concentration (less than 10.0 g/dL vs 10.0-11.0 g/dL) and type of concurrent chemotherapy (platinum-based vs non-platinum-based). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive darbepoetin alfa subcutaneously (SC) every other week for 12 weeks (i.e., on weeks 1, 3, 5, 7, 9, and 11).
• Arm II: Patients receive epoetin alfa SC once weekly for 12 weeks. Patients are followed at 1 and 3 weeks .

PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study within 6 months.

Inclusion criteria

• Diagnosis of a non-myeloid malignancy
• Currently receiving or planning to receive at least 8 weeks of cyclic cytotoxic chemotherapy
• Hemoglobin no greater than 11.0 g/dL
• 18 and over
• ECOG 0-2
• Bilirubin less than 2 times upper limit of normal (ULN)
• Creatinine less than 2 times ULN
• Negative pregnancy test
• Fertile patients must use effective contraception
• HIV negative
• More than 30 days since prior darbepoetin alfa or epoetin alfa
• More than 30 days since prior participation in investigational device or drug trials

Exclusion criteria

• The following diagnoses are excluded:

• Acute myeloid leukemia
• Chronic myeloid leukemia
• Acute lymphoblastic leukemia
• Hairy cell leukemia
• Burkitt's lymphoma
• Lymphoblastic lymphoma
• other primary hematologic disorder that would cause anemia (e.g., sickle cell anemia)
• angina
• congestive heart failure
• New York Heart Association class III or IV heart disease
• hypertension
• cardiac arrhythmia
• other unstable or uncontrolled disease or condition that would affect cardiac function
• pregnant or nursing
• known seizure disorder
• known sensitivity to study agents
• clinically significant inflammatory disease (e.g., rheumatoid arthritis or Crohn's disease)
• confirmed neutralizing antibodies to epoetin alfa
• other disorder that would preclude study compliance or giving informed consent
• other concurrent epoetin alfas
• prior randomization to this study
• other concurrent investigational agents or procedures