Darbepoetin Alfa and Anemia of Cancer

Amgen

Status and phase: Terminated; Phase 2

Conditions: Anemia; Non-Myeloid Malignancies; Neoplasms; Carcinoma; Anemia of Cancer; Cancer

Treatments: Biological: darbepoetin alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT00989092

20000219

Details and patient eligibility

About

This phase 2, multicenter, randomized, open-label, comparative study was designed to determine the effect of darbepoetin alfa on hospital days, economic outcomes, and health related quality of life (HRQOL) in anemic patients with nonmyeloid malignancies who were not receiving chemotherapy. Participants were randomly assigned in a 4:1 allocation ratio to receive either 21 weeks of darbepoetin alfa treatment (treatment group) or 12 weeks of observation followed by up to 9 weeks of darbepoetin alfa treatment (observation group).

Enrollment: 287 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• nonmyeloid malignancies (including lymphocytic leukemias)
• anemia (hemoglobin concentration less than or equal to 11.0 g/dL) due to cancer and/or previous chemotherapy or radiotherapy
• Eastern Cooperative Oncology Group performance status of 0 to 2
• adequate liver and renal functions
• 18 years or older

Exclusion criteria

• history of recombinant human erythropoietin therapy, cytotoxic chemotherapy, or more than 30 Gy radiotherapy to the whole pelvis within 4 weeks before screening
• acute myelogenous leukemia, chronic myelogenous leukemia, or myelodysplastic syndrome
• known hematologic disorders that could cause anemia
• inflammatory or cardiac disorders
• previous positive antibody response to any erythropoietic agent
• history of pure red cell aplasia

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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287 participants in 2 patient groups

Observational Group

Other group

Description:

Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered to the observation group during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participants hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.

Treatment:

Biological: darbepoetin alfa

21 week treatment group

Active Comparator group

Description:

Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at week 7 (to 5.0 μg/kg once every 2 weeks) or at week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at week 7.

Treatment:

Biological: darbepoetin alfa