Recurrent and/or metastatic Squamous cell carcinoma of the head and neck (SCCHN) MedDRA version: 7.0 Level: LLT Classification code 10025960
Conditions
Interventions
Trade Name: Erbitux
Product Code: EMD271786
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cetuximab
Current Sponsor code: EMD271786
Other descriptive name: C225
Concentration unit: m
Sponsors
Merck KGaA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • =18 years of age • Histologically or cytologically confirmed diagnosis of SCCHN • Recurrent and/or metastatic SCCHN, not suitable for local therapy • At least 1 bi-dimensionaly measurable lesion either by CT scan or MRI • Signed written informed consent before any study related activities are carried out • Tumor tissue available for immunohistochemical evaluation of EGFR expression • KPS of =70 at study entry • Effective contraception for both male and female subjects if risk of conception exists • Neutrophils =1500/mm³, platelet count =100000/mm³, and hemoglobin =9 g/dL • Total bilirubin =2 × upper limit of normality (ULN); aspartate-aminotransferase (AST) and alanine-aminotransferase (ALT) =3 × ULN • Creatinine clearance >60 mL/min Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range ;Inclusion criteria: • =18 years of age • Histologically or cytologically confirmed diagnosis of SCCHN • Recurrent and/or metastatic SCCHN, not suitable for local therapy • At least 1 bi-dimensionaly measurable lesion either by CT scan or MRI • Signed written informed consent before any study related activities are carried out • Tumor tissue available for immunohistochemical evaluation of EGFR expression • KPS of =70 at study entry • Effective contraception for both male and female subjects if risk of conception exists • Neutrophils =1500/mm³, platelet count =100000/mm³, and hemoglobin =9 g/dL • Total bilirubin =2 × upper limit of normality (ULN); aspartate-aminotransferase (AST) and alanine-aminotransferase (ALT) =3 × ULN • Creatinine clearance >60 mL/min Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to study entry • Surgery (excluding prior diagnostic biopsy), or irradiation within 4 weeks before study entry • Nasopharyngeal carcinoma • Active infection (infection requiring IV antibiotics), including active tuberculosis, and known and declared HIV. • Uncontrolled hypertension defined as systolic blood pressure =180 mmHg and/or diastolic blood pressure =130 mmHg under resting conditions • Pregnancy (absence confirmed by serum ß-HCG test) or lactation period • 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 insuffiency • Medical or psychological condition that would not permit the subject to complete the study or sign informed consent • Known drug abuse (with the exception of alcohol abuse) • Known allergic reaction against any of the components of the study treatment • Previous treatment with monoclonal antibody therapy, or other signal transduction inhibitors or EGFR targeting therapy • Previous or current other squamous cell carcinoma • Evidence of previous other malignancy within the last 5 years • Any investigational medication within 30 days before study entry ;Exclusion criteria: • Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to study entry • Surgery (excluding prior diagnostic biopsy), or irradiation within 4 weeks before study entry • Nasopharyngeal carcinoma • Active infection (infection requiring IV antibiotics), including active tuberculosis, and known and declared HIV. • Uncontrolled hypertension defined as systolic blood pressure =180 mmHg and/or diastolic blood pressure =130 mmHg under resting conditions • Pregnancy (absence confirmed by serum ß-HCG test) or lactation period • 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 insuffiency • Medical or psychological condition that would not permit the subject to complete the study or sign informed consent • Known drug abuse (with the exception of alcohol abuse) • Known allergic reaction against any of the components of the study treatment • Previous treatment with monoclonal antibody therapy, or other signal transduction inhibitors or EGFR targeting therapy • Previous or current other squamous cell carcinoma • Evidence of previous other malignancy within the last 5 years • Any investigational medication within 30 days before study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether overall survival time in subjects receiving cetuximab in combination with cisplatin or carboplatin + 5-FU is prolonged compared to subjects receiving cisplatin or carboplatin + 5-FU only, in the first-line treatment of recurrent and/or metastatic SCCHN.;Secondary Objective: The secondary objectives of this study are to compare the 2 treatment groups regarding the following: • Best overall response • Disease control • Duration of response • Time to treatment failure • Progression-free survival time • Safety • Quality of life (QoL);Primary end point(s): To show superiority of the overall survival time (in months) for the cetuximab + chemotherapy group compared to the chemotherapy only group.;Main Objective: To assess whether overall survival time in subjects receiving cetuximab in combination with cisplatin or carboplatin + 5-FU is prolonged compared to subjects receiving cisplatin or carboplatin + 5-FU only, in the first-line treatment of recurrent and/or metastatic SCCHN.;Secondary Objective: The secondary objectives of this study are to compare the 2 treatment groups regarding the following: • Best overall response • Disease control • Duration of response • Time to treatment failure • Progression-free survival time • Safety • Quality of life (QoL);Primary end point(s): To show superiority of the overall survival time (in months) for the cetuximab + chemotherapy group compared to the chemotherapy only group. | — |
Countries
Czech Republic, Hungary, Italy, Spain, Sweden, United Kingdom
Contacts
Public Contact; ;
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Outcome results
None listed