Aranesp and Neulasta in Patients With Sarcoma Receiving Adriamycin and Ifosfamide

Not Applicable

Completed

• Conditions: Sarcoma
• Interventions: Drug: Aranesp (darbepoetin alfa); Drug: Neulasta (pegfilgrastim); Drug: Adriamycin; Drug: Ifosfamide

• Registration Number: NCT00283621
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study Start: 2003-06-02
• Study First Submitted: 2006-01-27
• Study First Submitted QC: 2006-01-27
• Study First Posted: 2006-01-30
• Primary Completion: 2006-04-12
• Study Completion: 2006-04-12
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-05
• Last Update Posted: 2018-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Growth Factors + Adriamycin/Ifosfamide	Aranesp (darbepoetin alfa)	Growth Factors = Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta)
Growth Factors + Adriamycin/Ifosfamide	Neulasta (pegfilgrastim)	Growth Factors = Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta)
Growth Factors + Adriamycin/Ifosfamide	Adriamycin	Growth Factors = Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta)
Growth Factors + Adriamycin/Ifosfamide	Ifosfamide	Growth Factors = Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta)

Primary Outcome Measures

Name	Time	Method
Iron Stores	Blood drawn at baseline during cycle 3 and at the end of study.
CBC diff/platelet counts	Monitored at least twice a week and daily during severe myelosuppression.
Peripheral blood and bone marrows	Performed at baseline and post treatment.

Secondary Outcome Measures

Name	Time	Method
Neurocognitive functions and Symptom burden assessment	Assessed at baseline, after 3 cycles of treatment and at the end of the study.

Trial Locations

Locations (1)

UT MDAnderson Cancer Center; 🇺🇸 Houston, Texas, United States