Overview

Aranesp and Neulasta in Patients With Sarcoma Receiving Adriamycin and Ifosfamide

Status:
Completed
Trial end date:
2006-04-12
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Amgen
Treatments:
Darbepoetin alfa
Doxorubicin
Ifosfamide
Isophosphamide mustard
Liposomal doxorubicin
Criteria
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