Status:
COMPLETED
Aranesp and Neulasta in Patients With Sarcoma Receiving Adriamycin and Ifosfamide
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Amgen
Conditions:
Sarcoma
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 f...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 2 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2006
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00283621
Start Date
June 2 2003
End Date
April 12 2006
Last Update
November 7 2018
Active Locations (1)
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1
UT MDAnderson Cancer Center
Houston, Texas, United States, 77030