EUCTR2004-001667-22-ES进行中（未招募）不适用
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 Cetuximab (Erbitux) en combinación con cisplatino o carboplatino y 5-fluorouracilo en el tratamiento de primera línea de pacientes con carcinoma de células escamosas de cabeza y cuello recurrente y/o metastásico. - EXTREME
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 入组人数
- 420
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •=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
排除标准
- •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
研究者
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