NCT00036023

Brief 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 chemotherapy every three weeks. 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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2002

Completed
Last Updated

May 11, 2009

Status Verified

May 1, 2009

First QC Date

May 7, 2002

Last Update Submit

May 7, 2009

Conditions

LymphomaBreast NeoplasmsLung NeoplasmsMultiple MyelomaChronic Lymphocytic Leukemia

Interventions

darbepoetin alfaDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* Patients with non-myeloid malignancies \* Patients receiving at least 12 weeks of chemotherapy on a 3-week cycle schedule \* Patients with anemia (hgb \>/= 9.0 and \</= 11.0 g/dL)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • Glaspy J, Henry D, Patel R, Tchekmedyian S, Applebaum S, Berdeaux D, Lloyd R, Berg R, Austin M, Rossi G; Darbepoetin Alfa 20010162 Study Group. Effects of chemotherapy on endogenous erythropoietin levels and the pharmacokinetics and erythropoietic response of darbepoetin alfa: a randomised clinical trial of synchronous versus asynchronous dosing of darbepoetin alfa. Eur J Cancer. 2005 May;41(8):1140-9. doi: 10.1016/j.ejca.2005.01.021. Epub 2005 Apr 8.

    PMID: 15911237RESULT

Related Links

MeSH Terms

Conditions

LymphomaBreast NeoplasmsLung NeoplasmsMultiple MyelomaLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic DisordersLeukemia, B-CellLeukemia, LymphoidLeukemiaChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 7, 2002

First Posted

May 8, 2002

Last Updated

May 11, 2009

Record last verified: 2009-05