Chemotherapy, Radiation Therapy, and Cetuximab in Treating Patients With the Head and Neck Cancer

OBJECTIVES:

Primary

• Evaluate disease-free survival at 2 years in patients with poor prognosis squamous cell carcinoma of the head and neck treated with chemoradiotherapy and cetuximab after complete surgical resection.

Secondary

• Evaluate quality of life.
• Evaluate tolerability.
• Evaluate overall survival.
• Analyze germinal polymorphisms.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV on day 1. Treatment with cetuximab repeats every week for up to 8 courses. Patients also receive cisplatin IV on day 8. Treatment with cisplatin repeats every 3 weeks for up to 3 courses. Patients undergo concurrent radiotherapy 5 times a week for 7 weeks beginning on day 8.

After completion of study treatment, patients are followed at 1 month and then every 3 months for 2 years.

DISEASE CHARACTERISTICS:

• Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
• Must have undergone complete macroscopic resection
• Presence of ≥ 1 of the following poor prognostic factors after complete resection:

• Incomplete microscopic resection and N+
• Complete microscopic resection and > 2 N+
• Vascular and/or lymphatic embolism
• At least 2 peripheral nerve invasions
• Positive surgical margins and pT4 lesion
• No metastases

PATIENT CHARACTERISTICS:

• WHO performance status 0-2
• ANC > 1,500/mm^3
• Platelet count > 100,000/mm^3
• Hemoglobin > 9 g/dL
• Bilirubin < 1.5 times upper limit of normal (ULN)
• Serum creatinine < 1.25 times ULN and/or creatinine clearance > 55 mL/min
• Not pregnant or nursing
• Fertile patients must use effective contraception
• No serious and disabling cardiac, renal, hepatic, or respiratory failure
• No coronary artery disease or myocardial infarction within the past year
• No uncontrolled cardiac arrhythmia
• Other active and serious diseases allowed at discretion of the investigator
• No known severe allergy to cisplatin, cetuximab, or any of their excipients
• No other malignant disease diagnosed within the past 5 years except for basal cell carcinoma of the skin or in situ cervical cancer
• No psychological, familial, social, or geographic situations that preclude clinical follow up

PRIOR CONCURRENT THERAPY:

• No prior treatment (except surgery) for this cancer or another head and neck cancer
• At least 3 months since prior treatment with an investigational agent