Anemia in Patients with a Non-Myeloid Malignancy
Study Details
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.
Protocol Summary
Time to first hemoglobin response during the treatment period
Timeframe: during the treatment period
Overall incidence of adverse events, serious adverse events, and severe or life threatening adverse events
Timeframe: throughout study
Incidence, if any, of neutralizing antibody formation to study drug (darbepoetin alfa or rHuEPO)
Timeframe: throughout study
Average weekly dosage of study drug during the 16-week treatment period
Timeframe: 16-week treatment period
Receiving red blood cell (RBC) transfusion from week 5 to week 12
Timeframe: from week 5 to week 12
Change in FACT-Fatigue scale score from baseline to week 7
Timeframe: 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
Timeframe: throughout study
Profile of change in FACT-Fatigue scale score from baseline over the treatment period
Timeframe: from baseline over the treatment period
Change in FACT-Fatigue scale score from baseline to End of Treatment Period (EOTP)
Timeframe: from baseline to EOTP
Change in FACT-Physical Well-being scale score from baseline to EOTP
Timeframe: from baseline to EOTP
Receiving RBC transfusion during the treatment period
Timeframe: during the treatment period
Number of units of RBC transfused during the treatment period
Timeframe: during the treatment period
Achieving a hemoglobin response by week 7
Timeframe: baseline to week 7
Change in hemoglobin concentration from baseline to EOTP
Timeframe: from baseline to EOTP
Time to first hematopoietic response
Timeframe: throughout study
Achieving a hemoglobin correction
Timeframe: throughout study
Number and percentage of subjects who exceed the hemoglobin concentration threshold
Timeframe: throughout study