At a glance
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A Phase II Study to Evaluate the Pharmacokinetics, Safety, and Obtain a Preliminary Efficacy Assessment of Palifermin in Patients With Sarcoma Receiving Multicycle Chemotherapy With Doxorubicin and Ifosfamide
In Brief
A Phase 2 clinical trial evaluating Palifermin, Placebo, and 4 other interventions for Sarcoma and Oral Mucositis. Completed, enrolled 49 participants across 1 site.
Detailed Summary
Primary: 1. To evaluate the preliminary efficacy of palifermin in reducing the incidence and severity of oral mucositis (OM) in patients with sarcoma receiving multicycle chemotherapy. 2. To evaluate the pharmacokinetics (PK) of palifermin when given pre chemotherapy. 3. To evaluate the safety profile of palifermin when combined with multicycle chemotherapy. Exploratory: 1. To evaluate the biologic effect of palifermin on oral mucosa. 2. To investigate potential biomarker development by biochemical analysis in blood cells, serum, and plasma. 3. To investigate the effects of genetic variation in mucositis genes, drug metabolism genes, and drug target genes on patient response to the treatment regimen.
Study Details
Timeline
Interventions
180 mcg/kg 3 days prior to chemotherapy
Single dose 3 days prior to chemotherapy
30 mg/m\^2 IV continuous infusion for 72 hours; days 0, 1, 2 (infusion completing on day 3) (total dose = 90 mg/m\^2).
2.5 g/m\^2 IV bolus over 3 hours, days 0,1, 2, 3 (total dose = 10 g/m\^2); for patients receiving the AI Regimen.
2 mg IV on day 0, for patients with small cell histology receiving the AI Regimen.
120 mg/m\^2 on day 0, for patients receiving the AP Regimen.