Aranesp and Neulasta in Patients With Sarcoma Receiving Adriamycin and Ifosfamide

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00283621
• Other study ID #: ID02-326
• Status: Completed
• Phase: N/A
• Start date: June 2, 2003
• Est. completion date: April 12, 2006

Study information

• Verified date: November 2018
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: April 12, 2006
• Est. primary completion date: April 12, 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Sarcoma

Intervention

Drug:
• Aranesp (darbepoetin alfa)

• Neulasta (pegfilgrastim)

• Adriamycin

• Ifosfamide

Locations

Country	Name	City	State
United States	UT MDAnderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CBC diff/platelet counts		Monitored at least twice a week and daily during severe myelosuppression.
Primary	Iron Stores		Blood drawn at baseline during cycle 3 and at the end of study.
Primary	Peripheral blood and bone marrows		Performed at baseline and post treatment.
Secondary	Neurocognitive functions and Symptom burden assessment		Assessed at baseline, after 3 cycles of treatment and at the end of the study.

External Links

•   UT MD Anderson Cancer Center