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