EUCTR2006-001961-40-DK进行中（未招募）不适用
Phase II study of therapy with Cetuximab and Irinotecan every second week to Irinotecan resistant patients with metastatic colorectal cancer-effect and biological markers
Department of Oncology, University Hospital Herlev0 个研究点目标入组 100 人开始时间: 2006年6月30日最近更新:
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
- 入组人数
- 100
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
- •Patient with histological proven MCRC.
- •2.Patients must have measurable disease, according to RECIST criteria.
- •3.Irinotecan resistant disease i.e. progressive disease after at least 6 weeks of therapy with Irinotecan-containing therapy or within 3 months thereafter.
- •4.Age =18 years.
- •5.Performance status (WHO) of 0-2.
- •6.Patient must have a life expectancy of at least 3 months.
- •7.Adequate hematological function defined ANC ³1.5 x 109/l 1.Patient with histological proven MCRC.
- •2.Patients must have measurable disease, according to RECIST criteria.
- •3.Irinotecan resistant disease i.e. progressive disease after at least 6 weeks of therapy with Irinotecan-containing therapy or within 3 months thereafter.
- •4.Age =?18 years.
- •5.Performance status (WHO) of 0-2.
- •6.Patient must have a life expectancy of at least 3 months.
- •7.Adequate hematological function defined ANC ³1.5 x 109/l and platelets =100 x 109/l .
- •8.Adequate liver function defined as Bilirubin = 1,5 x UNL (upper normal limit) and/or ASAT/ALAT = 5 x UNL.
- •9.All should have been exposed to Oxaliplatin-containing therapy.
- •10.Written informed consent must be obtained according to the local Ethics Committee requirements.
- •platelets 100 x 109/l .
- •8.Adequate liver function defined as Bilirubin = 1,5 x UNL (upper normal limit) and/or ASAT/ALAT = 5 x UNL.
- •9.All should have been exposed to Oxaliplatin-containing therapy.
- •10.Written informed consent must be obtained according to the local Ethics Committee requirements.
- •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
- •1.Previous or some other concomitant malignancy, with the exception of adequately treated basal cell skin cancer or in situ cervical cancer.
- •2.Inability to follow the treatment and evaluation schedule.
- •3.Any other condition or therapy which in the investigator’s opinion may pose a risk to the patient or interfere with the study objectives.
- •4.Pregnant or lactating women. In fertile women this is ensured by a negative pregnancy test or use of safe antikonception (as defined by the Danish medicines agency during the study period and at least 3 months thereafter.
- •5.Patients with active infections or other serious underlying medical condition, which would impair the ability of the patients to receive the protocol treatment.
- •6.Known hypersensitivity to any of the components of the treatment.
- •7.Legal incapacity.
- •8.Reduced liver function defined by bilirubin > 5 x UNL or ASAT/ALAT > 5xUNL
研究者
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