Darbepoetin Alfa and Anemia of Cancer

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

287 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2004-06-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Anemia Anemia of Cancer Cancer Carcinoma Neoplasms Non-Myeloid Malignancies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Observational Group

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.

Group Type OTHER

darbepoetin alfa

Intervention Type BIOLOGICAL

Administered subcutaneously.

21 week treatment group

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.

Group Type ACTIVE_COMPARATOR

darbepoetin alfa

Intervention Type BIOLOGICAL

Administered subcutaneously.

Interventions

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darbepoetin alfa

Administered subcutaneously.

Intervention Type BIOLOGICAL

Other Intervention Names

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Aranesp®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No