A randomized phase II trial of irinotecan drug-eluting beads administered by hepatic chemoembolization with intravenous cetuximab (DEBIRITUX) versus systemic treatment with intravenous cetuximab and irinotecan in patients with refractory metastatic colorectal cancer and k-ras wild-type tumours - DEBIRITUX

Martin Luther Universität Halle-Wittenberg0 个研究点目标入组 80 人开始时间: 2009年11月4日最近更新: 2013年8月5日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Martin Luther Universität Halle-Wittenberg
入组人数: 80

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

•1) Patients with confirmed diagnosis of stage IV (UICC) colorectal cancer with unresectable liver metastases (primary tumour may be present) and k-ras wild-type tumours
•2) Patients had been treated and shown to be refractory to 5-FU (Capecitabine allowed)/oxaliplatin and/or 5-FU/irinotecan. Prior therapy with VEGF-inhibitors (e.g bevacizumab) is allowed
•3) Patients with at least one measurable liver metastasis, with size > 1cm (RECIST criteria)
•4) Patients with liver only or liver dominant disease (defined as = 50 % tumour burden confined to the liver)
•5) Patients with a portal vein not interfering with transarterial chemoembolization (e.g. no thrombosis) as judged by the investigator
•6) ECOG Performance status = 2
•7) Life expectancy > 3 months
•8) Age = 18 years.
•9) At least 4 weeks since last administration of last chemotherapy and/or radiotherapy (bone metastases may be allowed)
•10) Patients who received VEGF-inhibition (e.g. with bevacizumab) in prior therapy are eligible if stopped since 4-6 weeks before randomization
•11) Haematologic function: ANC = 1.5 x 109/L, platelets = 75 x109/L
•12) INR < 1.5 (patients on therapeutic anticoagulants are not eligible)
•13) Adequate liver function as measured by serum transaminases (AST & ALT) = 3 x ULN and total bilirubin = 1.5 x ULN
•14) Adequate renal function: Serum creatinine = 1.5 x ULN
•15) Normal level of serum magnesium
•16) Women of child bearing potential and fertile men are required to use effective contraception (negative serum _HCG for women of child-bearing age
•17) Signed, written informed consent
•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 80
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 80

排除标准

•1) Presence of CNS metastases
•2) Contradindications to irinotecan therapy (Chronic inflammatory bowel disease and/or bowel obstruction, history of severe hypersensitivity reactions to irinotecan hydrochloride trihydrate)
•3) Active bacterial, viral or fungal infection within 72 hours of study entry
•4) Women who are pregnant or breast feeding
•5) Allergy to contrast media
•6) Presence of another concurrent malignancy. Prior malignancy in the last 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
•7) Any contraindication for hepatic embolisation procedures:
•Large shunt as determined by the investigator (pretesting with lung perfusion scan not required)
•Severe atheromatosis
•Hepatofugal blood flow
•8) Other significant medical or surgical condition, or any medication or treatment, that would place the patient at undue risk, that would preclude the safe use of chemoembolization or would interfere with study participation
•9) Known hypersensitivity or contraindication to the drugs used in the trial (eg: cetuximab, 5-HT3 receptor antagonist, dexamethasone, or any component of aprepitant)

研究者

发起方

Martin Luther Universität Halle-Wittenberg

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