A Randomized Phase III Trial of Concurrent Accelerated Radiation and Cisplatin Versus Concurrent Accelerated Radiation, Cisplatin, and Cetuximab (C225) [Followed by Surgery for Selected Patients] for Stage III and IV Head and Neck Carcinomas

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically proven (from primary lesion and/or lymph nodes) squamous cell
carcinoma of the oropharynx, hypopharynx, or larynx

- Stage III or IV disease (T2, N2-3, M0; T3-4, any N, M0)

- No distant metastases

- The following primary tumor sites are excluded:

- Oral cavity

- Nasopharynx

- Sinuses

- Salivary glands

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-1

- Absolute neutrophil count (ANC) ≥ 1,800/mm^3

- Platelets ≥ 100,000/mm^3

- Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is
acceptable)

- Bilirubin ≤ 1.5 mg/dL (Gilbert's disease as the sole cause of elevated bilirubin may
be allowed at the discretion of the principal investigator)

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2 times the
upper limit of normal

- Serum creatinine ≤ 1.5 mg/dL

- Creatinine clearance ≥ 50 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Women of childbearing potential and male participants must agree to use a medically
effective means of birth control throughout their participation in the treatment
phase of the study (until at least 60 days following the last study treatment)

- No prior invasive malignancy (except non-melanomatous skin cancer) unless disease
free for a minimum of 3 years

- No unstable angina and/or congestive heart failure requiring hospitalization in past
6 months

- Left ventricular ejection fraction ≥ 45%

- No transmural myocardial infarction within the last 6 months

- No acute bacterial or fungal infection requiring intravenous antibiotics

- No chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy

- No acquired immune deficiency syndrome (AIDS)

- HIV testing is not required for entry into this protocol

- Protocol-specific requirements may also exclude immuno-compromised patients

- No prior allergic reaction to the study drug(s)

- No other uncontrolled condition, which in the opinion of the investigator, would
interfere in the safe and timely completion of study procedures

- No comorbidity of uncontrolled diabetes (i.e., symptomatic hyperglycemia)

- No other severe active comorbidity

PRIOR CONCURRENT THERAPY:

- No prior systemic chemotherapy for the study cancer

- Prior chemotherapy for a different cancer is allowed

- No prior radiotherapy to the region of the study cancer that would result in overlap
of radiation therapy fields

- No initial surgical treatment (excluding diagnostic biopsy of the primary site or
nodal sampling of neck disease)

- No radical or modified neck dissection

- No prior therapy that specifically and directly targets the EGFR pathway