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

Key Inclusion Criteria: * Histologically documented squamous cell carcinoma involving either the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx * Newly diagnosed, locally advanced stage head and neck cancer (unresectable/unresected disease); American Joint Committee on Cancer \[AJCC\] Stage III, IVA or IVB amenable to radiotherapy with concurrent chemotherapy as the definitive treatment modality * At least 50 Gray of radiation treatment to areas of the oral cavity/oropharynx mucosa that can be visualized * Concurrent chemotherapy regimen of Cisplatin 100mg/m\^2 on days 1, 22, and 43 * Eastern Cooperative Oncology Group (ECOG) performance status (PS) less than or equal to 2 * Adequate hematologic, renal and hepatic function * Negative pregnancy test by serum or urine * Signed informed consent Key Exclusion Criteria: \- Presence or history of any other primary malignancy (other than curatively treated in situ cervical cancer, or basal cell carcinoma of the skin without evidence of disease for greater than 3 years)