EUCTR2006-004030-32-AT进行中（未招募）1 期
Randomised study for efficiency of FOLFIRI in combination with Cetuximab vs. Bevacizumab in first-line-therapy of metastatic colorectal cancer - FIRE-3
Klinikum der Ludwig-Maximilians Universität München, Klinikum Großhadern0 个研究点目标入组 568 人开始时间: 2009年9月17日最近更新:
适应症
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
- 568
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
- •-Histologically confirmed adenocarcinoma of colon and rectum
- •-confirmation of a K-RAS wild type status (in the primary tumor or in metastasis)
- •-general condition: 0-2 (ECOG/ WHO)
- •-suitable for application of chemotherapy
- •-written informed consent (first and second-line therapy)
- •-Age 18- 75
- •-clinical or ambulant treatment
- •-Life expectancy > 3 months
- •-minimum one measurable indicator leasion according to RECIST. Evaluation of tumor manifestation 2 weeks or less before study entry.
- •-Male or female patients with reproductive potential must use an approved contraceptive method
- •-Leucocytes = 3,0 x 10\9/L with Neutrophils = 1,5 x 10\9/L, Thrombocytes = 100 10\9/L, Hemoglobin = 5,6 mmol/L equivalent to 9 g/dL
- •-Serum bilirubin = 1,5x upper NL
- •-ALAT and ASAT = 2,5 x upper NL, in case of liver metastases ALAT and ASAT = 5 x upper NL.
- •-Serum creatinine = 1,5 x upper NL
- •-An operation has to take place 4 weeks before study entry; a fine needle biopsy must have been performed more than 1 week ago. Wounds must have completely healed. The necessity of a big operation in the course of the study is not to be expected. An exception is a resection of liver metastases. If there should be the option of a secondary curative operation Bevacizumab has to be discontinued 6 to 8 weeks before operation.
- •-relevant toxicitys of therapies prior must have abated
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •- confirmation of a K-RAS mutation
- •- previous exposure to EGFR-targeting therapy
- •- previous treatment with Bevacizumab
- •- prior chemotherapy of colorectal cancer, except adjuvant chemotherapy which was terminated at least 6 month before study entry
- •- experimental medical treatment within 30 days before study entry
- •- known hypersensitivity to elements of the study drug
- •- pregnant (exclusion diagnosis by beta-hCG-test) or breast-feeding women
- •- clinically relevant coronary disease or myocardial infarction within 12 months before study entry or enhanced risk of uncontrolled arrhythmia
- •- acute or subacute intestinal obstruction or chronical-inflammatory enteritis during anamnesis or chronical diarrhea
- •- symptomatic peritoneal carcinosis
- •- serious, non-healing wounds, ulcera or bone fracture
- •- uncontrolled hypertonia
- •- pronounced proteinuria
- •- arterial thromboembolism or haemorrhage within 6 months before study entry (except tumor bleeding before tumorresection)
- •- hemorrhagic diathesis or thrombotic tendency
- •- therapeutic anticoagulation (marcumar-therapy, PTT-effective heparinization)
- •- known DPD-insufficience (special screening not necessary)
- •- known glucuronisation defect (Gilbert´s disease) (special screening not necessary)
- •- secondary malignancies during anamnesis within the last 5 years except curatively treated basalioma or in situ carcinoma of the cervix
- •- known alcohol- or drug abuse
- •- clinical or psychological disorders that would prohibit to give a valid informed consent or to perform the study
- •- a significant concomitant disorder which excludes the patient´s participation in from the study in the opinion of the responsible physician
- •- absent or constricted legal capacity
研究者
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