Cetuximab (Erbitux) in combination with cisplatin or carboplatin and 5-fluorouracil in the first line treatment of subjects with recurrent and/or metastatic squamous cell carcinoma of the head and neck - EXTREME
- Conditions
- Recurrent and/or metastatic Squamous cell carcinoma of the head and neck (SCCHN)MedDRA version: 7.0Level: LLTClassification code 10025960
- Registration Number
- EUCTR2004-001667-22-HU
- Lead Sponsor
- Merck KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 420
• =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
;
• =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
• 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
;
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method