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Chemotherapy Related Anemia in Patients With Non-Myeloid Malignancies
This study has been completed.
First Received: May 7, 2002   Last Updated: May 7, 2009   History of Changes
Sponsor: Amgen
Information provided by: Amgen
ClinicalTrials.gov Identifier: NCT00036023
  Purpose

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.


Condition Intervention Phase
Lymphoma
Breast Neoplasms
Lung Neoplasms
Multiple Myeloma
Chronic Lymphocytic Leukemia
Drug: darbepoetin alfa
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title: 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

Resource links provided by NLM:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00036023

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Amgen Inc. ( Global Development Leader )
Study ID Numbers: 20010162
Study First Received: May 7, 2002
Last Updated: May 7, 2009
ClinicalTrials.gov Identifier: NCT00036023     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Thoracic Neoplasms
Leukemia, Lymphoid
Blood Protein Disorders
Hematologic Agents
Paraproteinemias
Hemostatic Disorders
Leukemia
Hemorrhagic Disorders
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Leukemia, Lymphocytic, Chronic, B-Cell
Therapeutic Uses
Cardiovascular Diseases
Lymphoma
Breast Diseases
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Immunoproliferative Disorders
Skin Diseases
Immune System Diseases
Hematinics
Hematologic Diseases
Darbepoetin alfa
Vascular Diseases
Breast Neoplasms
Pharmacologic Actions
Multiple Myeloma
Lymphatic Diseases
Neoplasms

ClinicalTrials.gov processed this record on November 09, 2009