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 (CHANGE)

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 3

Conditions

Squamous Cell Carcinoma of the Head and Neck

Treatments

Biological: Cetuximab

Drug: Cisplatin

Drug: 5-Fluorouracil

Study type

Interventional

Funder types

Industry

Identifiers

NCT01177956

EMR62241_055

Details and patient eligibility

About

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.

Enrollment

73 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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