ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Chemotherapy Related Anemia in Patients With Non-Myeloid Malignancies

This study has been completed.

Sponsored by: 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

Genetics Home Reference related topics:   aceruloplasminemia    breast cancer    hemophilia   

MedlinePlus related topics:   Anemia    Breast Cancer    Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Lung Cancer    Lymphoma    Multiple Myeloma   

Drug Information available for:   Darbepoetin alfa   

U.S. FDA Resources

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
  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


AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Responsible Party:   Amgen Inc. ( Global Development Leader )
Study ID Numbers:   20010162
First Received:   May 7, 2002
Last Updated:   May 15, 2008
ClinicalTrials.gov Identifier:   NCT00036023
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Thoracic Neoplasms
Leukemia, Lymphoid
Blood Protein Disorders
Paraproteinemias
Hemostatic Disorders
Leukemia
Hemorrhagic Disorders
Multiple myeloma
Respiratory Tract Diseases
Leukemia, Lymphocytic, Chronic, B-Cell
Lung Neoplasms
Lymphoma
Breast Diseases
Chronic lymphocytic leukemia
Immunoproliferative Disorders
Skin Diseases
Hematologic Diseases
Blood Coagulation Disorders
Darbepoetin alfa
Anemia
Vascular Diseases
Breast Neoplasms
Multiple Myeloma
Lymphatic Diseases
Lung Diseases
Lymphoproliferative Disorders
Leukemia, B-Cell
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Immune System Diseases
Hematinics
Therapeutic Uses
Hematologic Agents
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




Links to all studies - primarily for crawlers