Phase II Trial of Induction Chemotherapy (ICT) Followed by Concurrent Chemoraditherapy (CR) With Monoclonal Antibody Cetuximab in Locally Advanced Head and Nec Squamous Cell Cancer

Inclusion Criteria:

1. Adult patients 18 years and older with histologically proven locally advanced stage
III or IV unresectable Squamous cell head and neck cancer SCCHN (including cancers of
oral cavity, oropharynx, larynx and hypopharynx) with no evidence of distant
metastasis

2. A careful evaluation for resection is required from the surgeon and criteria for
unresectability carefully defined for individual primary sites as follows:

- Hypopharynx: The tumor must extend across the midline of the posterior
pharyngeal wall or be fixed to the cervical spine

- Larynx: There must by either direct extension into surrounding muscle or skin or
greater than 3 cm of sub-glottic extension

- Oral cavity: The lesion must be so extensive that a functional reconstruction is
not possible.

- Base of Tongue: The tumor must extend into the roof of tongue, or the patient
must refuse a recommended total glossectomy

- Tonsil: The tumor must extend into the pterygoid region as manifested by
clinical trismus or demonstrated across the midline of the pharyngeal wall or
directly into soft tissue of the neck

- Patients with neck lymph node metastases fixed to the carotid artery, the
mastoid, the base of the skull, or the cervical spine are considered
un-resectable

- Medical unsuitability for resection is not sufficient for patient eligibility

- Patient's refusal for surgery except in case of total glossectomy is not
considered a reason for unresectibility

3. Patients must have received no prior treatment for head and neck cancer

4. ECOG Performance status 0-1

5. Adequate organ function (All labs should be obtained within 14 days prior to start of
study drug treatment)

- leukocytes > 3,000/mcL

- absolute neutrophil count > 1,500/mcL

- platelets > 100,000/mcL

- total Bilirubin within normal institutional limits

- AST (SGOT)/ALT(SGPT) < 2.5 X institutional upper limit of normal

- creatinine within normal institutional limits or creatinine clearance > 60
mL/min/1.73 m2 for patients with creatinine levels above institutional normal

6. Ability to give informed consent and willingness to adhere to study protocol

7. Subjects of reproductive potential must agree to follow accepted birth control
methods during treatment and for 12 months after completion of treatment. Female
subject is either post-menopausal or surgically sterilized or willing to use an
acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine
device, diaphragm with birth control (i.e., a hormonal contraceptive, intra-uterine
device, diaphragm with spermicide, condom with spermicide, or abstinence) for the
duration of the study

Exclusion Criteria:

1. Patient who have had prior treatment for head and neck cancer

2. Prior history of radiation to head and neck area

3. Known malignancy other than the current cancer

4. Uncontrolled intercurrent illness including but not limited to ongoing active
infection, history of cardiac disease, e.g. uncontrolled hypertension, unstable
angina, congestive heart failure, myocardial infarction within last six months or
ventricular arrhythmias requiring medication, psychiatric illness that would impair
patients ability to comply with study requirements

5. Pregnant or lactating women (any women becoming pregnant during the study will be
withdrawn from the study)

6. Patient with documented or symptoms of peripheral neuropathy

7. History of allergic reaction to compounds similar to the ones used in this study

8. Any condition that would hamper ability to give informed consent or ability to comply
with study protocol

9. HIV patients on anti-retroviral therapy are in-eligible to participate in this study
because of potential interaction with the study drugs and increase susceptibility for
infections during course of marrow suppressive chemotherapy and radiotherapy