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Chemotherapy Related Anemia in Patients With Non-Myeloid Malignancies

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00036023
First received: May 7, 2002
Last updated: May 7, 2009
Last verified: May 2009

May 7, 2002
May 7, 2009
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Complete list of historical versions of study NCT00036023 on ClinicalTrials.gov Archive Site
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Chemotherapy Related Anemia in Patients With Non-Myeloid Malignancies
A Randomized, Open-Label, Dose-Timing Study of Darbepoetin Alfa Administered Once Every 3 Weeks (Q3W) by Subcutaneous (SC) Injection for Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy

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.

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Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lymphoma
  • Breast Neoplasms
  • Lung Neoplasms
  • Multiple Myeloma
  • Chronic Lymphocytic Leukemia
Drug: darbepoetin alfa
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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. Epub 2005 Apr 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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  • 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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00036023
20010162
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Global Development Leader, Amgen Inc.
Amgen
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Study Director: MD Amgen
Amgen
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP