• Incidence of treatment-emergent proteinuria [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
• Duration of treatment-emergent proteinuria [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
• Incidence of chronic proteinuria [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
• Time (days) to onset of treatment-emergent proteinuria [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
• Maximum protein-to-creatinine ratio values during the treatment period [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
• Pharmacokinetic profile to include Systemic clearance, volume of distribution at steady state, estimated initial concentration, area under the conc-time curve, terminal half-life and mean residual time [ Time Frame: in Week 1 ] [ Designated as safety issue: No ]

• To evaluate the effect of palifermin on proteinuria.
• To evaluate the pharmacokinetic profile of palifermin administered at the dose of 120 μg/kg IV in a cohort of at least 12 (3 palifermin: 1 placebo) locally advanced HNC subjects receiving RT for their disease (postoperative setting)

• Time (days) to onset of severe Oral Mucositis WHO grade 3 or 4 [ Time Frame: 11 weeks ] [ Designated as safety issue: Yes ]
• Disease status at End of Treatment visit [ Time Frame: 11 weeks ] [ Designated as safety issue: Yes ]
• Incidence of serum anti-palifermin antibody formation [ Time Frame: 11 weeks ] [ Designated as safety issue: Yes ]
• Incidence of second primary tumors [ Time Frame: up to 10 years (Long-Term Follow-Up phase) ] [ Designated as safety issue: Yes ]
• Incidence of other malignancies [ Time Frame: up to 10 years (Long-Term Follow-Up phase) ] [ Designated as safety issue: Yes ]
• Progression-free survival [ Time Frame: up to 10 years (Long-Term Follow-Up phase) ] [ Designated as safety issue: Yes ]
• Overall survival [ Time Frame: up to 10 years (Long-Term Follow-Up phase) ] [ Designated as safety issue: Yes ]
• Incidence of adverse events and laboratory abnormalities [ Time Frame: 11 weeks ] [ Designated as safety issue: Yes ]
• Incidence (%) and duration (days) of severe Oral Mucositis WHO grade 3 or 4 [ Time Frame: 11 weeks ] [ Designated as safety issue: Yes ]

• To evaluate the safety and tolerability of palifermin when administered at the dose of 120 µg/kg weekly to subjects with surgically resected, locally advanced HNC receiving postoperative RT for their disease.
• To assess the preliminary efficacy of 120 µg/kg palifermin in reducing the incidence and duration of severe oral mucositis.
• To assess the preliminary efficacy of palifermin on the clinical sequelae of oral mucositis.
• To evaluate long-term effects of palifermin on disease outcome and survival.

The purpose of this study is to evaluate the efficacy, safety and tolerability of palifermin on the incidence of oral mucositis in subjects with locally advanced head and neck cancer receiving postoperative radiotherapy.

• Drug: Placebo
• Drug: palifermin

• Placebo Comparator:

  Approximately 17 subjects to receive palifermin. Subjects will be enrolled as follows:

  • PK cohort will be randomized in a 3:1 ratio [palifermin: placebo] in at least 12 subjects
  • Non-PK cohort will be randomized in a 1:1 ratio [palifermin: placebo] in up to 28 subjects.
• Experimental:

  Approximately 23 subjects to receive palifermin. Subjects will be enrolled as follows:

  • PK cohort will be randomized in a 3:1 ratio [palifermin: placebo] in at least 12 subjects
  • Non-PK cohort will be randomized in a 1:1 ratio [palifermin: placebo] in up to 28 subjects.

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