Darbepoetin Alfa in Treating Anemia in Patients With Cancer Who Are Receiving Chemotherapy

DISEASE CHARACTERISTICS:

• Diagnosis of a nonmyeloid malignancy

• Cancer- or chemotherapy-related anemia

  • Hemoglobin 9.0-11.0 g/dL

• Currently receiving chemotherapy on a 3-week course schedule

  • Myelosuppressive chemotherapy must not be administered on course days 9-21
  • At least 2 additional courses of chemotherapy planned
• 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 uncontrolled angina
• No congestive heart failure
• No New York Heart Association class III-IV cardiac disease
• No uncontrolled hypertension
• No cardiac arrhythmia
• No other unstable or uncontrolled cardiac disease or condition

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• HIV negative
• No seizure disorder
• No clinically significant inflammatory disease
• No hypersensitivity to recombinant mammalian-derived products

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior epoetin alfa or darbepoetin alfa
• No other concurrent epoetin alfas

Chemotherapy:

• See Disease Characteristics

Endocrine therapy:

• Not specified

Radiotherapy:

• Concurrent radiotherapy allowed

Surgery:

• Not specified

Other:

• At least 30 days since prior investigational drugs or devices
• No prior enrollment on this study
• No other concurrent investigational drugs
• No more than 2 red blood cell (RBC) transfusions within the past 4 weeks
• No RBC transfusions during the chemotherapy course before randomization