Cetuximab With Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck in Chinese Subjects
Condition: Squamous Cell Carcinoma of the Head and Neck
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Cetuximab + concomitant boost radiotherapy
Intervention description: Cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy: 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially
Once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by
Twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses are separated by at least a 6-hour interval
Intervention MeSH terms: Cetuximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: antitumor activity; safety; cetuximab in combination with radiotherapy; locally advanced squamous cell head & neck carcinoma

Summary:

      Primary objective: to assess the antitumor activity and safety profile of cetuximab when
      given in combination with radiotherapy (RT) for the treatment of locally advanced squamous
      cell carcinoma of the head and neck (SCCHN) in Chinese subjects.

      Secondary objective: to assess the pharmacokinetic (PK) profile and immunogenicity of
      cetuximab in Chinese subjects.

      Further objective: to identify for cetuximab potential predictive biomarkers of response and
      safety.
    

Eligibility criteria:

        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