Aranesp and Neulasta in Patients With Sarcoma Receiving Adriamycin and Ifosfamide

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00283621

Collaborator

Amgen (Industry)

Enrollment

Location

Arm

34.3

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma	Drug: Aranesp (darbepoetin alfa) Drug: Neulasta (pegfilgrastim) Drug: Adriamycin Drug: Ifosfamide	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

51 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 2, 2003

Actual Primary Completion Date :

Apr 12, 2006

Actual Study Completion Date :

Apr 12, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Growth Factors + Adriamycin/Ifosfamide Growth Factors = Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta)	Drug: Aranesp (darbepoetin alfa) Drug: Neulasta (pegfilgrastim) Drug: Adriamycin Other Names: Doxorubicin Hydrocholoride Adriamycin PFS Adriamycin RDF Drug: Ifosfamide Other Names: Ifex

Arm

Intervention/Treatment

Experimental: Growth Factors + Adriamycin/Ifosfamide

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

Drug: Aranesp (darbepoetin alfa)

Drug: Neulasta (pegfilgrastim)

Drug: Adriamycin

Other Names:

Doxorubicin Hydrocholoride

Adriamycin PFS

Adriamycin RDF

Drug: Ifosfamide

Other Names:

Ifex

Outcome Measures

Primary Outcome Measures

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

Neurocognitive functions and Symptom burden assessment [Assessed at baseline, after 3 cycles of treatment and at the end of the study.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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