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Chemotherapy Related Anemia in Patients with Non-Myeloid Malignancies



Chemotherapy Related Anemia in Patients with Non-Myeloid Malignancies

For Condition: Breast Neoplasms,Lung Neoplasms,Multiple Myeloma,Leukemia, Lymphocytic, Chronic,Lymphomas
Status: Completed
Sponsor(s): Amgen ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 Total Enrollment: 

Location and Contact Information:

Research Center
Philadelphia,  Pennsylvania, 
United States
 


Additional Information:
Study ID Numbers:
  20010162; 
Study Start Date: 
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036023

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