Aranesp and Neulasta in Patients With Sarcoma Receiving Adriamycin and Ifosfamide

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00283621
• Date of registration: 27/01/2006
• Primary sponsor: M.D. Anderson Cancer Center
• Public title: Aranesp and Neulasta in Patients With Sarcoma Receiving Adriamycin and Ifosfamide
• Scientific title: A Pilot Study of Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta) in Patients With Sarcoma Receiving Adriamycin and Ifosfamide
• Date of first enrolment: November 2002
• Target sample size: 51
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00283621
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Countries of recruitment

United States

Contacts

• Name: Saroj Vadhan-Raj, M.D.
• Affiliation: UT MDAnderson Cancer Center

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Sarcoma

Intervention(s)

Drug: Adriamycin

Drug: Aranesp (darbepoetin alfa)

Drug: Ifosfamide

Drug: Neulasta (pegfilgrastim)

Primary Outcome(s)

CBC diff/platelet counts [Time Frame: Monitored at least twice a week and daily during severe myelosuppression.]

Iron Stores [Time Frame: Blood drawn at baseline during cycle 3 and at the end of study.]

Peripheral blood and bone marrows [Time Frame: Performed at baseline and post treatment.]

Secondary Outcome(s)

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

Secondary ID(s)

ID02-326

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Amgen