临床试验/EUCTR2006-004065-34-DE

EUCTR2006-004065-34-DE进行中（未招募）不适用

Open labeled, multicenter phase I / II study evaluating the dose escalation/ safety of Cetuximab and Oxaliplatin/ 5-FU/FA/ Irinotecan as first-line treatment of metastatic colorectal cancer - COFI06

Technical University Dresden0 个研究点开始时间: 2006年11月2日最近更新: 2012年3月19日

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

研究概览入排标准研究者记录与标识符相似试验

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

•For inclusion in the study, all of the following inclusion criteria must be fulfilled:
•-Diagnosis of non-resectable, histologically confirmed, EGFR positive or negative colorectal cancer
•-WHO PS 0 or 1
•-Signed written informed consent
•-=18 years of age
•-Effective contraception for both male and female subjects if the risk of conception exists
•-Adequate bone marrow function: Neutrophiles blood cell count (NBC) = 1,5x109/L, platelet count = 100x109/L, hemoglobin = 5.96 mmol/L (10 g/dL)
•-Adequate liver and renal function: bilirubin = 1,5 x upper normal level (UNL) and not increasing more than 25% within the last 4 weeks, ASAT and ALAT = 5 x UNL. Serum creatinine = 1.5 x UNL.
•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

•Subjects are not eligible for this study if any of the following exclusion criteria apply:
•-Previous exposure to epidermal growth factor receptor-targeting therapy
•-Previous chemotherapy for colorectal cancer except adjuvant treatment with progression of disease documented > 6 months after end of adjuvant treatment or 5-FU in combination with radiotherapy for rectal cancer
•-Radiotherapy or major abdominal or thoracic surgery within the last 4 weeks before inclusion.
•-Concurrent chronic systemic immune therapy, chemotherapy or hormone therapy.
•-Investigational agents or participation in clinical trials within 30 days before start of the treatment in study.
•-Clinically relevant coronary disease or myocardial infarction within 12 months before study entry.
•-Peripheral neuropathy > CTC grade I
•-Inflammatory bowel disease
•-Previous malignancy (except colorectal cancer, history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment)
•-History of severe psychiatric illness
•-Drug or alcohol abuse
•-Known hypersensitivity reaction to any of the components of study treatments
•-Pregnancy (absence to be confirmed by b-hCG test) or lactation period
•-Brain metastasis and/or leptomeningeal disease (known or suspected)
•-Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease

研究者

发起方

Technical University Dresden

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