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Anemia in Patients With a Non-Myeloid Malignancy

NCT00038064 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 707

Last updated 2008-09-15

No results posted yet for this study

Summary

Chemotherapy can often cause anemia in patients with cancer. Anemia is a low number of red blood cells. The symptoms of anemia may include fatigue, dizziness, headache, chest pain, and shortness of breath. Erythropoietin is a hormone made by the kidneys that signals the bone marrow to produce more red blood cells. Recombinant human erythropoietin has been produced in the laboratory and has the same effect as the hormone produced by the body. Use of recombinant human erythropoietin allows the body to produce more red blood cells, possibly eliminating or decreasing your symptoms and the need for a red blood cell transfusion. Recombinant human erythropoietin is FDA approved to treat anemia in cancer patients receiving chemotherapy. This clinical study is investigating the effectiveness of darbepoetin alfa for the treatment of anemia in patients with non-myeloid malignancies who are receiving multicycle chemotherapy. Darbepoetin alfa is a recombinant erythropoietic protein that stimulates the production of red blood cells. This medication has not been approved to treat cancer patients with anemia, however it has been approved by the FDA to treat chronic renal failure patients with anemia.

Conditions

Interventions

DRUG

Darbepoetin alfa

Darbepoetin alfa will be administered 4.5 mcg/kg QW until hemoglobin correction is achieved. Subjects meeting hemoglobin criteria for correction will receive a maintenance dose of darbepoetin alfa of 4.5 mcg/kg Q3W.

DRUG

rHuEPO

150 IU/kg TIW

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-31
Primary Completion
2003-10-31
Completion
2004-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00038064 on ClinicalTrials.gov