A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy

Inclusion Criteria: * History of newly diagnosed histologically confirmed squamous cell carcinoma (AJCC Stage II, III or IVA) involving either the oral cavity, oropharynx, hypopharynx, larynx and post surgical resection (R0 or R1) * Candidates for postoperative RT-only treatment and scheduled to receive RT within 12 weeks of surgery * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 * Urinary protein-creatinine ratio (random sample, spot PCR) ≤ 0.2 mg/mg Exclusion Criteria: * Tumors of the lips, paranasal sinuses, salivary glands, or of unknown primary tumors and R2 resection margins * Metastatic disease (M1) * 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 \> 3 years * History of pancreatitis * Prior radiotherapy to the site of disease * Prior chemotherapy or requiring chemotherapy during treatment phase of study * Prior treatment with palifermin, or other fibroblast or keratinocyte growth factors