A Phase II Trial of Postoperative Radiation, Cisplatin, and Panitumumab in Locally Advanced Head and Neck Cancer

Inclusion Criteria:

- Pathologically staged squamous cell carcinoma of the head and neck, stage III or IVa
(AJCC 6th edition 2002) of the oral cavity, larynx, or hypopharynx that is status
post potentially curative surgical resection without gross residual tumor, except the
following: a)T3N0 laryngeal primary and b) any T1N1, if there are no high-risk
pathologic features (high risk defined as positive margins, extracapsular spread, and
perineural or angiolymphatic invasion).

- Patients should not have gross residual disease.

- No prior chemotherapy, biologic/targeted therapy (including any prior therapy which
specifically and directly targets the EGFR pathway), or radiotherapy for head and
neck cancer. A brief course, up to 2 weeks, of prior neoadjuvant single-agent
biologic/targeted therapy of any type (except EGFR monoclonal antibodies) prior to
surgical resection is permitted.

- No more than 6 7 weeks (minimum of 3 weeks) should have elapsed between surgery and
initiation of radiation.

- No prior radiation or chemotherapy for head and neck cancer.

- ECOG performance status of 0-1

- Patients must have normal organ and marrow function

- No prior invasive malignancy unless the DFS is 3 years or more.

- Age > 18 years.

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

- Informed consent must be obtained from all patients prior to beginning therapy.
Patients should have the ability to understand and the willingness to sign a written
informed consent document.

- Patients who have tumor tissue available from previous diagnostic or therapeutic
procedures should submit the specimen for assessment of EGFR and related biomarkers
after signing informed consent.

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 curatively treated squamous
cell or 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.

- No patients with significant baseline sensory or motor neurologic deficits(> grade I
neuropathy) will be treated on this study.

- Pregnant women are excluded from this study because chemotherapy and radiation
therapy have the potential for teratogenic or abortifacient effects. Because there is
an unknown but potential risk for adverse events in nursing infants secondary to
treatment of the mother with chemotherapy, breastfeeding should be discontinued if
the mother is treated with chemotherapy.

- Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of
the importance of avoiding pregnancy during trial participation and the potential
risk factors for an unintentional pregnancy. In addition, men enrolled on this study
should understand the risks to any sexual partner of childbearing potential and
should practice an effective method of birth control.

- All WOCBP MUST have a negative urine pregnancy test at baseline, or within 7 days
prior to receiving investigational product. The minimum sensitivity of the pregnancy
test must be 25 IU/L or equivalent units of HCG. If the urine pregnancy test is
positive, a serum pregnancy test will then be performed to confirm the result. In the
event that both the urine and serum pregnancy tests are positive, the subject must
not receive investigational product and must not be enrolled in the study.

- In addition, all WOCBP should be instructed to contact the Investigator immediately
if they suspect they might be pregnant (e.g., missed or late menstrual period) at any
time during study participation.

The Investigator must immediately notify Amgen in the event of a confirmed pregnancy in a
patient participating in the study.

-Prior severe infusion reaction to a human monoclonal antibody.