Phase I Study Panitumumab Plus Chemoradiotherapy and Induction Chemotherapy in Patients With Locally Advanced Squamous Cell Cancer of the Head and Neck

Inclusion Criteria:

- Histologically or cytologically proven squamous cell carcinoma of the head and neck
or its variants (such as basaloid squamous cell carcinoma, undifferentiated
carcinoma, or adenosquamous cell carcinoma). Primary tumor sites eligible include:
nasopharynx, oral cavity, oropharynx, hypopharynx, larynx or unknown primary SCCHN

- Stage III or IV disease, without evidence of distant metastasis, according to
American Joint Committee on Cancer

- Measurable disease, according to RECIST.

- No prior chemotherapy, radiotherapy or attempted complete resection of the SCCHN.
Diagnostic biopsy, including excisional nodal biopsy and/or tonsillectomy is allowed
if the subject has measurable disease at the time of enrollment

- 18 years of age or older

- ECOG Performance Status of 0 or 1

- No active alcohol addiction or other condition that, in the opinion of the study
investigators, would interfere with the subject's ability to comply with the
treatment plan

- Adequate hepatic and renal function

- Women of childbearing potential must have a negative pregnancy test within 2 weeks of
study entry.

Exclusion Criteria:

- Pregnant or breast feeding women

- Symptomatic peripheral neuropathy of grade 2 or higher by NCI CTCAEv3.0

- Grade 3 or more hearing loss

- History of other malignancy within the previous 5 years, except for nonmelanoma skin
cancer, carcinoma in situ of the cervix, bladder or head and neck

- Prior radiation to head and neck

- Other serious illness or medical conditions

- Patients who experienced an involuntary weight loss of more than 20% of their body
weight in the 2 months preceding study entry

- Concurrent treatment with any other anticancer therapy

- Prior therapy which affects or targets the ErbB pathway, including any inhibitors of
EGFR and ErbB2

- Participation in an investigational drug trial within 30 days of study entry