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

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Cetuximab; Cisplatin; Fluorouracil

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