Open-label, Single-arm, Multicenter, Phase III Trial to Assess the Antitumor Activity and Safety of Cetuximab When Given in Combination With Radiotherapy for the Treatment of Locally Advanced Squamous Cell Carcinoma of the Head and Neck in Chinese Subjects
Inclusion Criteria:
- Inpatient greater than or equal to (>=) 18 years of age
- Pathologically proven squamous cell carcinoma arising in the oropharynx, hypopharynx
or larynx
- Stage III or IV disease with an expected survival of at least 12 months
- Medically suitable to withstand a course of concomitant boost RT
- Presence of at least 1 bi-dimensionally 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 at trial entry
- Neutrophils >=1.5*10^9/Liter (L), platelet count >= 100*10^9/L, hemoglobin >= 90
gram/liter (g/L)
- Total bilirubin less than or equal to (<=) 2*upper limit of normal (ULN); aspartate
aminotransferase (AST) and alanine aminotransferase (ALT) <= 3*ULN
- Serum creatinine <=133 micromole/liter (mcmol/L)
- Serum calcium within normal range
- Effective contraception if procreative potential exists (applicable to both male and
female subjects)
- Chinese with Chinese citizenship
- Signed written informed consent
Exclusion Criteria:
- Evidence of distant metastatic disease
- Squamous cell carcinoma arising in the nasopharynx or oral cavity
- Receipt of prior systemic chemotherapy within the last 3 years
- Previous surgery for the tumor under study other than biopsy
- Receipt of prior RT to the head and neck
- Currently receiving RT as part of a postoperative regimen following primary surgical
resection
- Planned neck dissection after trial RT
- 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
- Previous treatment with monoclonal antibody therapy, other signal transduction
inhibitors or epidermal growth factor receptor (EGFR) targeting therapy
- Evidence of previous other malignancy within the last 5 years
- Intake of any investigational medication within 30 days before trial entry
- Other protocol-defined exclusion criteria may apply