A Pilot Study of Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta) in Patients With Sarcoma Receiving Adriamycin and Ifosfamide
18 Years
65 Years
Both
Sarcoma
Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
CBC diff/platelet counts
Outcome Time Frame:
Monitored at least twice a week and daily during severe myelosuppression.
Safety Issue:
No
Principal Investigator
Saroj Vadhan-Raj, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
UT MDAnderson Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
ID02-326
NCT ID:
NCT00283621
Start Date:
November 2002
Completion Date:
April 2006
Related Keywords:
- Sarcoma
- Aranesp
- Darbepoetin Alfa
- Pegfilgrastim
- Neulasta
- Sarcoma
- Adriamycin
- Doxorubicin Hydrocholoride
- Adriamycin PFS
- Adriamycin RDF
- Ifosfamide
- Sarcoma
Name | Location |
|---|---|
| UT MDAnderson Cancer Center | Houston, Texas 77030 |
