Aranesp and Neulasta in Patients With Sarcoma Receiving Adriamycin and Ifosfamide

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Study of Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta) in Patients With Sarcoma Receiving Adriamycin and Ifosfamide

Conditions
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Sarcoma

Intervention / Treatment
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* Drug: Aranesp (darbepoetin alfa)
* Drug: Neulasta (pegfilgrastim)
* Drug: Adriamycin
* Drug: Ifosfamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Growth Factors + Adriamycin/Ifosfamide<br>Growth Factors = Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta) | Drug: Aranesp (darbepoetin alfa)<br> <br> Drug: Neulasta (pegfilgrastim)<br> <br> Drug: Adriamycin<br> <br> * Other names: Adriamycin RDF;Drug: Ifosfamide<br> <br> * Other names: Ifex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurocognitive functions and Symptom burden assessment |  | Assessed at baseline, after 3 cycles of treatment and at the end of the study. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aranesp, Darbepoetin Alfa, Pegfilgrastim, Neulasta, Sarcoma, Adriamycin, Doxorubicin Hydrocholoride, Adriamycin PFS, Adriamycin RDF, Ifosfamide