Aranesp and Neulasta in Patients With Sarcoma Receiving Adriamycin and Ifosfamide

M.D. Anderson Cancer Center

Status: Completed

Conditions: Sarcoma

Treatments: Drug: Ifosfamide; Drug: Aranesp (darbepoetin alfa); Drug: Adriamycin; Drug: Neulasta (pegfilgrastim)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00283621

ID02-326

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

Growth Factors + Adriamycin/Ifosfamide

Experimental group

Description:

Growth Factors = Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta)

Treatment:

Drug: Neulasta (pegfilgrastim)

Drug: Adriamycin

Drug: Ifosfamide

Drug: Aranesp (darbepoetin alfa)