A Phase II Randomized Trial Of Surgery Followed By Chemoradiotherapy Plus Cetuximab For Advanced Squamous Cell Carcinoma Of The Head and Neck

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed squamous cell carcinoma of the head and neck meeting the
following criteria:

- Site of tumor origin in the oral cavity, oropharynx, larynx, or hypopharynx
(excluding lip, nasopharynx, or sinuses)

- Gross total resection must be completed within 7 weeks of randomization, with
pathology demonstrating one or more of the following risk factors:

- Histologic extracapsular nodal extension

- Histologic involvement of ≥ 2 regional lymph nodes

- Invasive cancer seen on microscopic evaluation of the resection margin,
with no evidence of gross tumor residual. or lymphoepithelioma of the oral
cavity, oropharynx, larynx, or hypopharynx

- Tonsillar cancer patients who undergo transoral excision of all gross tumor
are eligible provided extracapsular nodal extension or involvement of ≥ 2
regional lymph nodes is histologically confirmed

- Stage III or IV disease after gross total resection completed within the past 7
weeks

- No evidence of distant metastases

- No synchronous or concurrent head and neck primary tumors

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count ≥ 2,000/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin > 8.0 g/dL

Hepatic

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST or ALT, and alkaline phosphatase meeting 1 of the following parameters:

- Alkaline phosphatase ≤ ULN AND AST or ALT ≤ 5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN

- Alkaline phosphatase ≤ 5 times ULN AND AST or ALT ≤ ULN

Renal

- Creatinine ≤ 1.5 mg/dL

Cardiovascular

- No unstable angina

- No uncontrolled hypertension

- No myocardial infarction within the past 6 months (unless successfully treated with
coronary artery bypass surgery or percutaneous transluminal coronary angioplasty)

- No uncontrolled arrhythmia

- No congestive heart failure

- No more than 2 heart-related hospitalizations within the past year

- No other active cardiac disease

Pulmonary

- No more than 2 hospitalizations for chronic obstructive pulmonary disease within the
past year

Neurologic

- No pre-existing peripheral neuropathy ≥ grade 2

- No uncontrolled seizure disorder

- No active neurological disease

Other

- No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with
polysorbate 80

- No other invasive malignancy within the past 3 years except nonmelanoma skin cancer

- No other concurrent illness that would preclude study participation

- No concurrent psychiatric illness that would preclude study participation

- No other concurrent physical condition (e.g., infectious disease) that would preclude
study participation

- No prisoners

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after study
participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior anti-epidermal growth factor receptor antibody therapy

Chemotherapy

- More than 3 years since prior cytotoxic chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- No prior head and neck radiotherapy

- No concurrent intensity-modulated radiotherapy

Surgery

- See Disease Characteristics

Other

- No prior tyrosine kinase inhibitor therapy