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 multicycle chemotherapy. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
707
Darbepoetin alfa will be administered 4.5 mcg/kg QW until hemoglobin correction is achieved. Subjects meeting hemoglobin criteria for correction will receive a maintenance dose of darbepoetin alfa of 4.5 mcg/kg Q3W.
150 IU/kg TIW
Time to first hemoglobin response during the treatment period
Time frame: during the treatment period
Overall incidence of adverse events, serious adverse events, and severe or life threatening adverse events
Time frame: throughout study
Incidence, if any, of neutralizing antibody formation to study drug (darbepoetin alfa or rHuEPO)
Time frame: throughout study
Average weekly dosage of study drug during the 16-week treatment period
Time frame: 16-week treatment period
Receiving red blood cell (RBC) transfusion from week 5 to week 12
Time frame: from week 5 to week 12
Change in FACT-Fatigue scale score from baseline to week 7
Time frame: from baseline to week 7
Percentage of subjects who have a rapid rate of hemoglobin concentration rise and negative clinical consequences associated with this rise
Time frame: throughout study
Profile of change in FACT-Fatigue scale score from baseline over the treatment period
Time frame: from baseline over the treatment period
Change in FACT-Fatigue scale score from baseline to End of Treatment Period (EOTP)
Time frame: from baseline to EOTP
Change in FACT-Physical Well-being scale score from baseline to EOTP
Time frame: from baseline to EOTP
Receiving RBC transfusion during the treatment period
Time frame: during the treatment period
Number of units of RBC transfused during the treatment period
Time frame: during the treatment period
Achieving a hemoglobin response by week 7
Time frame: baseline to week 7
Change in hemoglobin concentration from baseline to EOTP
Time frame: from baseline to EOTP
Time to first hematopoietic response
Time frame: throughout study
Achieving a hemoglobin correction
Time frame: throughout study
Number and percentage of subjects who exceed the hemoglobin concentration threshold
Time frame: throughout study
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