Chemotherapy Related Anemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2003-04-30

Brief Summary

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This study is investigating darbepoetin alfa for the treatment of anemia in patients with non-myeloid cancers who are receiving chemotherapy. Darbepoetin alfa is a recombinant protein that stimulates the production of red blood cells. In this study, darbepoetin alfa will be administered as either an injection under the skin (subcutaneously) or directly into a vein (intravenously).

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Detailed Description

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Conditions

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Anemia 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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Darbepoetin alfa SC

Group Type ACTIVE_COMPARATOR

Darbepoetin alfa SC

Intervention Type DRUG

Subcutaneous (SC) injection of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W

Darbepoetin alfa IV

Group Type EXPERIMENTAL

Darbepoetin alfa IV

Intervention Type DRUG

Intravenous administration of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W

Interventions

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Darbepoetin alfa SC

Subcutaneous (SC) injection of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W

Intervention Type DRUG

Darbepoetin alfa IV

Intravenous administration of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with a non-myeloid malignancy
* Scheduled to receive a minimum of an additional 12 weeks of chemotherapy from the time of first dose of study drug
* Screening hemoglobin concentration less than or equal to 11.0g/dL
* ECOG performance status of 0 to 2
* Adequate renal and liver function

Exclusion Criteria

* History of seizure disorder
* Received recombinant human erythropoietin (rHuEPO) or darbepoetin alfa therapy within 4 weeks before study day 1
* More than 2 red blood cell transfusions within 4 weeks before study day 1, or any red blood cell transfusion within 14 days before study day 1

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No