Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer
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
Outcome
Met primary endpoint
registry NUMBER Placebo: Yes: 62 participants NUMBER Palifermin: Yes: 51 participants NCT00101582 ↗
registry analysis (superiority or other test); Placebo vs Palifermin; p = 0.0410; Chi-Square Statistic 4.1764; Cochran-Mantel-Haenszel NCT00101582 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Palifermin | Protein / enzyme biologic | 180 ug/kg | Intravenous |
| Background | Cisplatin | Other / unclassified | 100 mg/m2 | Intravenous |