Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: 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

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: 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

Relevance to patient case: not relevant