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

Conditions: Squamous Cell Carcinoma of the 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 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

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)