A Pilot Study of Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta) in Patients With Sarcoma Receiving Adriamycin and Ifosfamide
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
CBC diff/platelet counts
Monitored at least twice a week and daily during severe myelosuppression.
Saroj Vadhan-Raj, M.D.
UT MDAnderson Cancer Center
United States: Food and Drug Administration
|UT MDAnderson Cancer Center||Houston, Texas 77030|