To determine the percentage of patients and number of cycles in which a packed red blood cell transfusion was administered due to anemia and in which antibiotics were administered due to neutropenic fever.
The use of hematopoietic growth factors have been shown to reduce neutropenic complications and red cell transfusion requirements associated with chemotherapy. This trial will study the combination of pegfilgrastim and darbepoetin alfa administered once per cycle of chemotherapy. Prior experience with growth factors in this setting provides historical data for comparison of safety and activity of these newer longer acting growth factors in reducing the incidence of febrile neutropenia requiring antibiotics and anemia requiring transfusions. The once dosing per cycle would simplify the patient management and would improve patient convenience and compliance.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
51
UT MDAnderson Cancer Center
Houston, Texas, United States
CBC diff/platelet counts
Time frame: Monitored at least twice a week and daily during severe myelosuppression.
Iron Stores
Time frame: Blood drawn at baseline during cycle 3 and at the end of study.
Peripheral blood and bone marrows
Time frame: Performed at baseline and post treatment.
Neurocognitive functions and Symptom burden assessment
Time frame: Assessed at baseline, after 3 cycles of treatment and at the end of the study.
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