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

Date de début de l'étude : 1 avril 2004

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. * 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 * American Joint Committee on Cancer (AJCC) pathological stage III or IV * 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) * Aspartate aminotransferase (AST) or alanine aminotransferase (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 * 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 Surgery * See Disease Characteristics Other * No prior tyrosine kinase inhibitor therapy