A Trial to Determine the Safety and Anti-tumor Activity Profile of the Combination of Cetuximab and Concomitant Cisplatin Plus 5-Fluorouracil (5-FU) in Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma in Head and Neck

Inclusion Criteria:

• Signed written informed consent

• Inpatient

• Greater than or equal to (>=) 18 years of age

• Histologically or cytologically confirmed diagnosis of SCCHN

• Recurrent and/or metastatic SCCHN not suitable for local therapy

• Presence of at least 1 measurable lesion identified either by computed tomography (CT)scan or magnetic resonance imaging (MRI) according to modified WHO criteria

• Karnofsky performance status (KPS) >= 80 percent at trial entry

• Neutrophils >= 1.510^9 per liter (L), platelet count >= 10010^9 per L, andhemoglobin >= 90 gram per liter (g/L)

• Total bilirubin less than or equal to (<=) 2upper limit of normal (ULN); aspartateaminotransferase (AST) and alanine aminotransferase (ALT) <=3ULN

• Serum creatinine <=133 micromole per liter (mcmol/L)

• Serum calcium within normal range

• Effective contraception if procreative potential exists (applicable for both male andfemale subjects)

Exclusion Criteria:

• Prior systemic chemotherapy, except if given as part of a multimodal treatment whichwas completed more than 6 months prior to trial entry

• Surgery (excluding prior diagnostic biopsy) or irradiation within 4 weeks before trialentry

• Nasopharyngeal carcinoma

• Active infection (infection requiring IV antibiotics), including active tuberculosis,or known and declared human immunodeficiency virus (HIV)

• Uncontrolled diabetes mellitus, pulmonary fibrosis, acute pulmonary disorder,interstitial pneumonia, cardiac failure or liver failure

• Uncontrolled hypertension defined as systolic blood pressure >=180 millimeter ofmercury (mmHg) and/or diastolic blood pressure >=130 mmHg under resting conditions

• Pregnancy (absence to be confirmed by serum beta human chorionic gonadotrophin [beta-HCG] test) or breastfeeding

• Concomitant chronic systemic immune therapy or hormonal therapy as cancer therapy

• Other concomitant anticancer therapies

• Documented or symptomatic brain or leptomeningeal metastasis

• Clinically relevant coronary artery disease or history of myocardial infarction in thelast 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiacinsufficiency

• Medical or psychological condition that would not permit the subject to complete thetrial or sign informed consent

• Known drug abuse (with the exception of alcohol abuse)

• Known hypersensitivity or allergic reaction against any of the components of the trialtreatment

• Previous treatment with monoclonal antibody therapy, other signal transductioninhibitors or epidermal growth factor receptor (EGFR) targeting therapy

• Previous or current other squamous cell carcinoma (SCC)

• Evidence of previous other malignancy within the last 5 years

• Signs and symptoms suggestive of transmissible spongiform encephalopathy, or familymembers who suffer(ed) from such

• Intake of any investigational medication within 30 days before trial entry

• Legal incapacity or limited legal capacity

• Other significant disease that in the Investigator's opinion would exclude the subjectfrom the trial