Chemotherapy With Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer (TPEx)

Inclusion Criteria:

• Histologically proven squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx
• Recurrent disease, incurable disease as determined by surgery or radiation, or metastatic disease
• Measurable or evaluable disease
• Age > 18 years and <= 70 years
• WHO performance status 0 or 1
• Absolute neutrophil count > 1,500/mm3
• Platelets > 150,000/mm3
• Total Bilirubin <= institutional upper limit of normal
• Aspartate aminotransferase < 1.5 X institutional upper limit of normal
• Alanine aminotransferase < 1.5 X institutional upper limit of normal
• Alkaline phosphatase < 2.5 X institutional upper limit of normal
• creatinine clearance > 60 mL/min
• Signed informed consent
• Women of child-bearing potential and men must be willing and able practice adequate contraception prior to study entry and for the duration of study treatment

Exclusion Criteria:

• Previous chemotherapy. Chemotherapy given as part of initial curative therapy and completed more than 6 months before inclusion is allowed
• Previous treatment with total doses of cisplatin > 300 mg/ m2
• Patients must not have any co-existing disease that would preclude cisplatin administration, such as peripheral neuropathy or renal failure
• Surgery (excluding biopsy) or radiotherapy within 4 weeks prior to study entry
• Nasopharyngeal carcinoma, or cancer of sinusal cavities
• Active infection including tuberculosis or HIV positive patient
• Other malignancy within last 5 years except for non-melanoma skin cancer
• No other investigational agent within 30 days prior to study entry
• No other concurrent chemotherapy, immunotherapy, antitumor hormonal therapy (excluding contraceptives and replacement steroids), radiotherapy, or experimental medications
• No prior anti EGFR therapy
• No known brain metastases
• Uncontrolled intercurrent illness that would prevent delivery of protocol therapy
• Patients with a prior history of basal cell carcinoma of the skin or in situ carcinoma of the cervix must have been curatively treated and must have remained disease free for 5 years post diagnosis
• No history of hypersensitivity reaction to drugs on study
• No unstable angina or myocardial infarction within the past 12 months
• No symptomatic congestive heart failure or New York Heart Association (NYHA) class II-IV heart disease
• No serious uncontrolled cardiac arrhythmia
• No other prior or concomitant squamous cell carcinoma
• No other prior or concomitant cancer, except curatively treated basal carcinoma of the skin or in situ cervical cancer, for which the patient has been curatively treated and remains disease-free for the past 5 years
• Patient is pregnant or lactating
• Patients must not have any co-existing condition that would preclude full compliance with the study