Study of Cetuximab in Combination With Chemotherapy in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Condition: Squamous Cell Carcinoma of the Head and Neck
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Cetuximab; Cisplatin/Carboplatin; 5-Fluorouracil
Intervention description: The initial dose of cetuximab will be 400 milligram per square meter (mg/m^2) as an intravenous (IV) infusion over 120 minutes. Subsequent weekly doses will be 250 mg/m^2 as an IV infusion over 60 minutes.; Subjects will receive 100 mg/m^2 cisplatin as an IV infusion over 60 minutes on day 1 of each 3-week treatment cycle. If subject developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) will be administered as an IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.; Subjects will receive 1000 mg/m^2 per day 5-FU as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle.
Intervention MeSH terms: Carboplatin; Fluorouracil; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Recurrent and/or metastatic; SCCHN

Summary:

      The primary objective of this trial is to assess the antitumor activity of cetuximab when
      given in combination with cisplatin + 5-Fluorouracil (5-FU) for the first-line treatment of
      recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) in Japanese
      subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically or cytologically confirmed diagnosis of SCCHN

          2. Confirmed epidermal growth factor receptor (EGFR) expression in tumor tissue by
             immunohistochemistry (IHC)

          3. Expected survival is more than 6 months

          4. Presence of at least 1 bidimensionally measurable lesion either by computed tomography
             (CT) scan or magnetic resonance imaging (MRI)

          5. Recurrent and/or metastatic SCCHN not suitable for local therapy

          6. Greater than or equal to (>=) 20 years of age

          7. Karnofsky performance status (KPS) >= 70% at trial entry

          8. Neutrophils: >= 1500 per millimeter^3 (1,500/mm^3); platelet count >= 100,000/mm^3;
             and hemoglobin >= 9 gram per deciliter (g/dL)

          9. Total bilirubin less than or equal to (<=) 2 * upper limit of normal (ULN); aspartate
             aminotransferase (AST) and alanine aminotransferase (ALT) <= 3 * ULN

         10. Creatinine clearance >60 milliliter per minute (mL/min).Calculated based on formulae
             such as the Cockroft-Gault formula for creatinine clearance

         11. Serum calcium within normal range (If serum albumin < 4.0 g/dL, the following adjusted
             serum calcium concentration should be within normality: Adjusted serum calcium
             concentration = actual serum calcium (milligram per deciliter [mg/dL]) - 0.8 * [actual
             serum albumin (g/dL) - 4]

         12. Effective contraception if risk of conception exists (applicable for both male and
             female subjects)

         13. Signed written informed consent

         14. Japanese (with Japanese citizenship)

        Exclusion Criteria:

          1. Nasopharyngeal carcinoma

          2. Prior systemic chemotherapy, except if given as part of a multimodal treatment, which
             was completed more than 6 months prior to trial entry

          3. Surgery (excluding prior diagnostic biopsy) or irradiation within 4 weeks before trial
             entry

          4. Pregnancy (absence to be confirmed by serum/urine human chorionic gonadotropin [HCG]
             test) or breastfeeding

          5. Known hypersensitivity or allergic reaction against any of the components of the trial
             treatment including excipients

          6. Uncontrolled diabetes, malignant hypertension (defined as systolic blood pressure >=
             180 millimeter of mercury [mmHg] and/or diastolic blood pressure >= 130 mmHg under
             resting conditions) or liver failure

          7. Pulmonary fibrosis, acute lung injury or interstitial pneumonia, or with previous
             medical history of these states

          8. Active infection, (infection requiring IV antibiotics, antibacterial, antifungal, or
             antiviral agent), including active tuberculosis, or known and declared human
             immunodeficiency virus (HIV)

          9. 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

         10. Current other squamous cell carcinoma (SCC) or previous other malignancy (excluding
             skin cancer except for melanoma and carcinoma in situ of the cervix or digestive
             tract) within the last 5 years

         11. Intake of any investigational medication within 30 days before trial entry

         12. Other concomitant anticancer therapies

         13. Documented or symptomatic brain or leptomeningeal metastasis

         14. Medical or psychological condition that would not permit the subject to complete the
             trial or sign informed consent including known drug abuse

         15. Previous treatment with monoclonal antibody therapy, other signal transduction
             inhibitors or EGFR targeting therapy

         16. Legal incapacity or limited legal capacity

         17. Other protocol-defined exclusion criteria may apply