drugset / Trial / NCT00101582

Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer

NCT00101582

Phase 3 Completed 188 enrolled Swedish Orphan Biovitrum Amgen · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this research study is to test the safety and effectiveness of palifermin to determine if weekly doses can be safely administered to reduce the incidence (occurrence of), duration (length of time) and severity (amount of pain) of oral mucositis (painful sores in the mouth). Mucositis is a common side effect for patients receiving chemotherapy (cancer-killing drug) and radiotherapy (cancer-killing x-rays) for the treatment of head and neck cancer (HNC).

Timeline

Start
2005-08
Primary completion
2007-09
Completion
2016-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Palifermin Protein / enzyme biologic 180 ug/kg Intravenous
Background Cisplatin Other / unclassified 100 mg/m2 Intravenous