OBJECTIVES:

Primary

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

Secondary

• Compare the safety of these drugs in these patients.

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.

DISEASE CHARACTERISTICS:

• Diagnosis of a non-myeloid malignancy

  • The following diagnoses are excluded:

    • Acute myeloid leukemia
    • Chronic myeloid leukemia
    • Acute lymphoblastic leukemia
    • Hairy cell leukemia
    • Burkitt's lymphoma
    • Lymphoblastic lymphoma
• Currently receiving or planning to receive at least 8 weeks of cyclic cytotoxic chemotherapy
• Hemoglobin no greater than 11.0 g/dL
• No other primary hematologic disorder that would cause anemia (e.g., sickle cell anemia)

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• See Disease Characteristics

Hepatic

• Bilirubin less than 2 times upper limit of normal (ULN)

Renal

• Creatinine less than 2 times ULN

Cardiovascular

• No angina
• No congestive heart failure
• No New York Heart Association class III or IV heart disease
• No hypertension
• No cardiac arrhythmia
• No other unstable or uncontrolled disease or condition that would affect cardiac function

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• HIV negative
• No known seizure disorder
• No known sensitivity to study agents
• No clinically significant inflammatory disease (e.g., rheumatoid arthritis or Crohn's disease)
• No confirmed neutralizing antibodies to epoetin alfa
• No other disorder that would preclude study compliance or giving informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 30 days since prior darbepoetin alfa or epoetin alfa
• No other concurrent epoetin alfas

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• More than 30 days since prior participation in investigational device or drug trials
• No prior randomization to this study
• No other concurrent investigational agents or procedures