A Phase II Multi-Center Study of Concomitant Cetuximab and Cisplatin With Re-Irradiation Using Intensity-Modulated Radiotherapy in Patients With Recurrent Squamous Cell Carcinoma of the Head-and-Neck

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Pathologically confirmed squamous cell carcinoma (SCC) of the upper aerodigestive
tract

- Recurrent disease or second primary SCC

- Recurrence or second primary must be confined to the head and neck above the
clavicles (loco-regional recurrence)

- Majority (≥ 75%) of the recurrent tumor must be in areas previously irradiated
to ≥ 45 Gy

- More than one recurrence allowed provided the first recurrence occurred > 6
months after the completion of prior radiotherapy

- Unresectable disease OR has high-risk features after resection (e.g., positive
margins and/or extracapsular extension)

- No signs of carotid exposure

- No primary nasopharyngeal or salivary gland tumor

- Equivocal pulmonary nodes on chest CT scan allowed provided they are < 1 cm, cannot
be safely biopsied, or are negative on PET scan

- No distant metastasis

PATIENT CHARACTERISTICS:

- Karnofsky performance status 70-100%

- ANC ≥ 2,000/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)

- Bilirubin < 1.5 mg/dL

- AST or ALT < 2 times upper limit of normal

- Creatinine clearance ≥ 50 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to submit prior radiotherapy records to assure that the spinal cord tolerance is
not exceeded

- No active cardiac disease, including any of the following:

- Unstable angina

- Uncontrolled hypertension

- Myocardial infarction within the past 6 months (unless successfully treated with
coronary artery bypass graft or percutaneous transluminal coronary angioplasty)

- Uncontrolled arrhythmia

- Congestive heart failure

- At least 3 heart-related hospitalizations within the past year

- No severe chronic obstructive pulmonary disease requiring ≥ 3 hospitalizations within
the past year

- No concurrent medical illness that would impair patient tolerance to therapy or limit
survival

- No other invasive malignancy within the past 2 years

- No pre-existing peripheral sensory neuropathy ≥ grade 2

- No prior severe infusion reaction to a monoclonal antibody

- No prisoners or individuals who are compulsorily detained (involuntarily
incarcerated) for treatment of either a psychiatric or physical (e.g., infectious)
illness

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Recovered from prior surgery

- Prior cisplatin and cetuximab allowed

- At least 6 months since prior radiotherapy or chemotherapy

- No prior radiotherapy > 75 Gy

- No prior chemotherapy for recurrent head and neck cancer

- Prior chemotherapy as a component of the primary treatment allowed

- No prior combination cisplatin, cetuximab, and radiotherapy for recurrent head and
neck cancer

- Patients with a new primary head and neck cancer whose prior primary head and
neck cancer was treated with concurrent cisplatin, cetuximab, and radiotherapy
are eligible provided it has been > 6 months since treatment