Overview
Aranesp and Neulasta in Patients With Sarcoma Receiving Adriamycin and Ifosfamide
Status:
Completed
Completed
Trial end date:
2006-04-12
2006-04-12
Target enrollment:
0
0
Participant gender:
All
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/AAccepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
M.D. Anderson Cancer CenterCollaborator:
AmgenTreatments:
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