Open-label, Single-arm, Multicenter, Phase III Trial to Assess the Antitumor Activity and Safety Profile of Cetuximab When Given in Combination With Chemotherapy for the First-line Treatment of Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck in Asian Subjects
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 World Health
Organization (WHO) criteria
- Karnofsky performance status (KPS) >= 80 percent at trial entry
- Neutrophils >= 1.5*10^9 per liter (L), platelet count >= 100*10^9 per L, and
hemoglobin >= 90 gram per liter (g/L)
- Total bilirubin less than or equal to (<=)*upper limit of normal (ULN); aspartate
aminotransferase (AST) and alanine aminotransferase (ALT) <=3*ULN
- Serum creatinine <=133 micromole per liter (mcmol/L)
- Serum calcium within normal range
- Effective contraception if procreative potential exists (applicable for both male and
female subjects)
Exclusion Criteria:
- Prior systemic chemotherapy, except if given as part of a multimodal treatment which
was completed more than 6 months prior to trial entry
- Surgery (excluding prior diagnostic biopsy) or irradiation within 4 weeks before
trial entry
- 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 of
mercury (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
the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac
insufficiency
- Medical or psychological condition that would not permit the subject to complete the
trial 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
trial treatment
- Previous treatment with monoclonal antibody therapy, other signal transduction
inhibitors 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 family
members 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
subject from the trial