Sarcoma
Conditions
Keywords
Aranesp, Darbepoetin Alfa, Pegfilgrastim, Neulasta, Sarcoma, Adriamycin, Doxorubicin Hydrocholoride, Adriamycin PFS, Adriamycin RDF, Ifosfamide
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 fever.
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 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.
Interventions
Sponsors
Amgen
M.D. Anderson Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CBC diff/platelet counts | Monitored at least twice a week and daily during severe myelosuppression. |
| Iron Stores | Blood drawn at baseline during cycle 3 and at the end of study. |
| Peripheral blood and bone marrows | Performed at baseline and post treatment. |
Secondary
| Measure | Time frame |
|---|---|
| Neurocognitive functions and Symptom burden assessment | Assessed at baseline, after 3 cycles of treatment and at the end of the study. |
Countries
United States
Outcome results
None listed