drugset / Trial / NCT00360971
Palifermin in Lessening Oral Mucositis in Patients Undergoing Radiation Therapy and Chemotherapy for Locally Advanced Head and Neck Cancer
Phase 3
Terminated
21 enrolled
Radiation Therapy Oncology Group
National Cancer Institute (NCI) · collab
RandomizedParallel-groupTriple-blindSupportive care
Summary
RATIONALE: Growth factors, such as palifermin, may lessen the severity of mucositis, or mouth sores, in patients receiving radiation therapy and chemotherapy for head and neck cancer. It is not yet known whether palifermin is more effective than a placebo in lessening mucositis in patients receiving radiation therapy and chemotherapy for head and neck cancer. PURPOSE: This randomized phase III trial is studying palifermin to see how well it works compared to a placebo in lessening oral mucositis in patients undergoing radiation therapy and chemotherapy for locally advanced head and neck cancer.
Timeline
- Start
- 2006-07
- Primary completion
- 2008-05
- Completion
- 2009-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Palifermin | Protein / enzyme biologic | 180 ug/kg | Intravenous |
| Background | Cisplatin | Other / unclassified | 100 mg/m2 | Intravenous |