Phase II Trial of Postoperative Radiotherapy and Panitumumab in High-Risk Salivary Gland Malignancies

Inclusion Criteria:

- Pathologically determined salivary gland cancer of the major or minor salivary glands
of the head and neck (any histology) status post potentially curative surgical
resection with no macroscopic residual disease. Patients should have AJCC 6th edition
stage III with 1) extracapsular extension, 2) perineural invasion, 3) positive
surgical margins or 4) high grade histology or stage IVA or IVB.

- No distant metastasis.

- No prior chemotherapy, biological-targeted therapy (including any prior therapy which
specifically and directly targets the EGFR pathway), or radiotherapy for head and
neck cancer.

- No more than 10 weeks (minimum of 3 weeks) should elapse between surgery and
treatment on study.

- ECOG performance status of 0-2.

- Patients must have normal organ and marrow function.

- No prior invasive malignancy unless the disease-free survival is 3 years or more.

- Age 18+ years.

- Pregnant or breast-feeding women are excluded (see exclusion criteria).

- Informed consent must be obtained fkom all patients prior to beginning research
related treatment.

- Patients should have the ability to understand and the willingness to sign a written
informed consent document.

Exclusion Criteria:

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection or psychiatric illness/social situations that would limit compliance with
study requirements.

- Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension,
unstable angina, recent myocardial infarction (within prior 6 months) uncontrolled
congestive heart failure, and cardiomyopathy with decreased ejection fraction. All
patients will have a baseline EKG. If abnormalities consistent with active coronary
artery disease are detected, the patient will be referred to a cardiologist for
appropriate evaluation and management prior to treatment on study.

- Patients may not be receiving any other investigational agents.

- No history of prior malignancy, with the exception of basal carcinoma of the skin or
in situ cervical cancer, or malignancy that has been treated with a curative intent
with a 3-year disease-free survival.

- Pregnant women are excluded from this study because chemotherapy and radiation
therapy have the potential for teratogenic or abortifacient effects.

- Prior severe ifision reaction to a human monoclonal antibody.