Conditions: Anemia Non-Myeloid Malignancies
Keywords: anemia chemotherapy induced anemia darbepoetin alfa cancer
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 243
Healthy volunteers: no

Brief summary:
To deterime the efficacy of 500 μg and 300 μg darbepoetin alfa administered subcutaneously (SC) on an every 3 weeks (Q3W) schedule, and the effect of intravenous (IV) iron supplementation in the treatment of anemia in patients with non-myeloid malignancies who were receiving multicycle chemotherapy.

Detailed description:

Arms:
arm 1: Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). arm 2: Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). arm 3: Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). arm 4: Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).

Interventions: intervention 1: darbepoetin alfa intervention 2: IV iron dextran
Intervention descriptions: intervention 1: Darbepoetin alfa administered by subcutaneous injection. intervention 2: Administered by intravenous (IV) injection.

Protocol document: