A Trial to Determine the Safety and Anti-tumor Activity Profile of the Combination of Cetuximab and Concomitant Cisplatin Plus 5-Fluorouracil (5-FU) in Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma in Head and Neck
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; 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.
Chemotherapy will be continued for up to a maximum of six 3-week cycles in the absence of progressive disease (PD) or unacceptable toxicity. All subjects will receive cetuximab treatment until the occurrence of PD or unacceptable toxicity to cetuximab.; Subjects will receive 75 mg/m^2 cisplatin as an IV infusion over 60 minutes on day 1 of each 3-week treatment cycle.; Subjects will receive 750 mg/m^2 per day 5-FU as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle.
Intervention MeSH terms: Fluorouracil; Cetuximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Recurrent and/or metastatic squamous cell carcinoma of the head and neck; 1st-line; Cetuximab; Chemotherapy; EMR 62241 -055; Merck KGaA; Recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN)

Summary:

      The primary objective of this trial is to assess the antitumor activity and safety profile 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 in Head and Neck (SCCHN) in
      Asian subjects.
    

Eligibility criteria:

        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 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 (<=) 2*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