EUCTR2009-015952-11-DK进行中（未招募）1 期
Phase Fase II examination of irinotecan, cetuximab and everolimus for patients resistente to chemoptherapy with metastatic colorectal cancer and KRAS mutation or with KRAS wildtype after progression on therapy with irinotecan og cetuximab – effect and biological markers. - ICE
Department of OncologyHerlev University Hospital0 个研究点目标入组 100 人开始时间: 2009年10月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 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
- •Criteria for inclusion:
- •1.Patients with a histological or cytological verified adenocarcinoma of the colon or rectum with non-resectable or metastatic cancer.
- •2.Patients with measurable disease without previous radiotherapy according to RECIST criteria.
- •3.Patients with metastatic colorectal cancer with progression after previous therapy with 5-fluoropyrimidiner, oxaliplatin or irinotecan. Patients should have been treated with oxaliplatin, but if oxaliplatin has be contraindicated or not tolerated the patient can participate in the trial.
- •4.Patients with KRAS mutation in their primary tumour or metastasis.
- •5.Patients with progression after therpay with irinotecan or cetuximab undependent of KRAS mutation status. .
- •6.Previous radiotherapy is allowed to less than 25 % of the bone marrow.
- •7.Age more or equal to 18 years.
- •8.Performance status (WHO) less than 3.
- •9.An expected survival time of at least 3 months.
- •10.Absolute Neutrophil Count (ANC) ?1,5 x 109/l and trombocyt count =100 x 109/l.
- •11.Normal liver function with bilirubin =1,5 x UNL (upper normal limit) og ASAT/ALAT < 5 x UNL. No UNL for ASAT/ALAT is required in patients with livermetastasis.
- •12.Signed informed consent according to specifications from the ethical comitees.
- •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
- •Criterai for exclusion:
- •1.Former or other concurrent malignant disease exept treated basal cell carcinoma or in situ cervical cancer.
- •2.No cytotoxic therapy or other experimental treatment within 28 days before inclusion.
- •3.No former therapy with everolimus or other rapamyciner (sirolimus, temsirolimus).
- •4.No known hypersensitivity for one or more components in the therapy.
- •5.No uncontrolled diabetes defined as a fasting blod sucker > 1.5 x ULN (upper normal limit).
- •6.No serious non-healing wounds, gastic ulcers, bonefractures, greater surgical procedures, major traumatic injuries within 28 days before inclusion.
- •7.No ungoing bleading or pathological condition associated with a risk of bleading.
- •8.No liverdisease as cirrhose, chronical active hepatitis or chronic persistent hepatitis.
- •9.No gastrointestinal disturbences in function that might cause a major change in the absortion of everolimus as ulcerative disease, ucontrolled nausea, vomiting, diarrhoe, malabsorption syndrom.
- •10.No planned immunisation with attenuated virus in the study period.
- •11.Patients thjat is unable to follow treatment or evaluation plan.
- •12.Every condition or therapy that after the judgement of investigator might infer the patient a risk or influence the trials objective.
- •13.Pregnant or breastfeeding women. At fertile women this is insured by a negative test of pregnancy or use of a safe antikonception during the trial period and at least 3 months after end of treatment.
- •14.Patients with active infections or other serious medical co-morbidity, that might prevent the patient from being treated with the protocoled therapy.
- •15.Incapacitated,
研究者
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