Study of Cetuximab With Concomitant-boost Radiotherapy in Patients With Newly Diagnosed Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Condition: Carcinoma of the Head and Neck
MeSH terms: Carcinoma; Squamous Cell Carcinoma of Head and Neck
Intervention: Cetuximab
Intervention description: Patients receive Cetuximab at an initial dose of 400 mg/m^2 of Cetuximab to be infused 6 or 7 days before starting radiotherapy, followed by subsequent weekly infusions at a dose of 250 mg/m^2 of Cetuximab and RT (72.0 Gy total in 42 fractions) for the next 6 weeks of the treatment course. Subjects will receive Cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of Cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with Cetuximab monotherapy every 7 days is continued.
Intervention MeSH terms: Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN)

Summary:

      This study is conducted in Japanese newly diagnosed locally advanced SCCHN patients in order
      to assess tolerability and feasibility of Cetuximab plus concomitant boost radiotherapy (RT)
      regimen (the study treatment) and its safety profile (i.e. AEs: adverse events). In addition,
      efficacy (i.e. anti-tumor effect) of the study treatment is also evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The patient has pathologically proven squamous cell carcinoma arising in the
             oropharynx, hypopharynx, or larynx.

          2. The patient has been confirmed Epidermal Growth Factor Receptor expressing in tumor
             specimen by immunohistochemistry.

          3. The patient has stage III or IV disease (Unio Internationalis Contra Cancrum /
             International Union against Cancer Tumor-Lymph Nodes-Metastases classification) with
             an expected survival of ≥ 12 months.

          4. The patient has at least bi-dimensionally measurable disease.

          5. The patient is medically suitable to withstand a course of the definitive radiation
             therapy.

          6. The patient aged ≥ 20 years old at informed consent

          7. The patient's Karnofsky performance status is ≥ 60

          8. Hemoglobin ≥ 9g/dL

          9. Neutrophil ≥ 1500/mm^3

         10. Platelet ≥ 100,000/mm^3

         11. Total Bilirubin ≤ 1.5 mg/dL

         12. Aspartate Aminotransferase ≤ 2 x the upper limit of normal

         13. Alanine Aminotransferase ≤ 2 x the upper limit of normal

         14. Serum creatinine ≤ 1.5 mg/dL

         15. Serum calcium concentration: within normality

         16. The patient is eligible if disease free from a previously treated malignancy for
             greater than three years.

         17. The patient agrees to use effective contraception if procreative potential exists.

         18. The patient has given signed informed consent

         19. The patient who is a Japanese with Japanese citizenship

        Exclusion Criteria:

          1. The patient has evidence of distant metastatic disease. The patient who has any
             metastatic disease documented by Magnetic Resonance Imaging for the head and neck, and
             Computed Tomography for the chest and abdomen should be excluded.

          2. The patient has squamous cell carcinoma arising in the nasopharynx or oral cavity.

          3. The patient has received prior systemic chemotherapy within the last three years.

          4. The patient has undergone previous surgery for the tumor under study other than
             biopsy.

          5. The patient has received prior radiation therapy to the head and neck.

          6. The patient's radiation therapy is considered to be a part of a postoperative regimen
             following primary surgical resection.

          7. The patient is pregnant or breast feeding.

          8. The patient has received prior Cetuximab or murine monoclonal antibody (including
             chimeric antibody) therapy or a history of severe hypersensitivity to any component of
             Cetuximab solution for Injection.

          9. The patient has a medical or psychological condition that would not permit the patient
             to complete the study or sign informed consent (including drug abuse).

         10. The patient has uncontrolled diabetes mellitus, malignant hypertension, or liver
             failure.

         11. The patient has or has suffered from a pulmonary fibrosis, acute pulmonary disorder,
             or interstitial pneumonia.

         12. The patient has an active infection (infection requiring intravenous anti-bacterial,
             anti-fungus, or anti-viral agent), or known and declared Human Immunodeficiency Virus
             infection.

         13. The patient has a 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

         14. The patient has a dental disease which requires incision and drainage.

         15. The patient has active multiple cancers (excluding skin cancer except for melanoma,
             and carcinoma in situ of the cervix or the digestive tract) in the last 3 years.

         16. The patient has been received some investigational medication within 30 days before
             study entry.