Aranesp and 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.

Inclusion Criteria:

- Patients with sarcoma which is locally advanced, at high risk for relapsed or
metastatic for whom treatment with AI is indicated

- Must be between 18-65 years of age

- Women of childbearing potential should use effective contraceptive measures

- Adequate hematologic, renal, and hepatic functions

- Karnofsky performance status above or equal to 80

Exclusion Criteria:

- Pregnant or lactating women.

- Patients with comorbid condition which renders patients at high risk of treatment
complication

- Patients with metastatic disease to CNS

- Patients with significant cardiac abnormalities

- History of seizure disorder in the past 5 years

- Patient has received any packed red blood cell transfusion within 2 weeks before study
entry

- Prior surgery or radiation therapy within 2 weeks of study entry

- History of prior chemotherapy for sarcomas

- Iron deficiency

- Hypersensitivity to E.coli derived products