NCT00989469已完成1 期
SORAFENIB (NEXAVAR®) in Combination With Irinotecan in the Second Line Treatment or More of Metastatic Colorectal Cancer With K-RAS Mutation : a Multicentre Two-part Phase I/II Study.
Institut du Cancer de Montpellier - Val d'Aurelle5 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2009年2月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 5
- 主要终点
- disease control
研究概览
简要总结
A multicentre two-part phase I/II study evaluating response and safety of SORAFENIB in combination with irinotecan in the second line treatment or more of metastatic colorectal cancer with K-RAS mutation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18
- •Written informed consent
- •Histologically proven adenocarcinoma of the colon or rectum asymptomatic primary tumour or surgically removed mCRC patients with previously unresectable metastatic disease
- •Patient with at least one tumoral lesion: measurable in a unidimensional way with a spiral scanner according to RECIST, no previous irradiation in this area
- •Disease progression after irinotecan-based chemotherapy
- •Disease progression after one or more previous lines of chemotherapy received in metastatic situation
- •WHO <= 2
- •Patient having a mutated KRAS on 12 or 13 codons on the primary tumour or a metastasis
- •Adequate liver function : Bilirubin ≤ 1,5 x UNL, ASAT ou ALAT ≤ 2,5 x UNL (or < 5 x UNL for subjects having a hepatic insufficiency in connection with hepatic metastases)
- •Polynuclear neutrophils ≥ 1 500/mm3
- •Haemoglobin > 10g/dl
- •Platelets ≥ 100 000/mm3
- •Amylase and lipase < 1,5 x UNL
- •Serum Creatinin < 1,5 x UNL
- •Adapted contraceptive measures during treatment and continued at least three months after end of the treatment
- •Life expectancy > 3 months
- •Affiliated to or benefiting from health insurance
排除标准
- •Gilbert's disease
- •Brain metastases or carcinomatous symptomatic meningitis
- •Exclusive bone metastasis
- •Previous cancers not considered as cured in the 5 years before inclusion (except for baso-cellular skin carcinoma) Surgery (except diagnostic biopsy) or radiotherapy within 4 weeks before inclusion
- •Disorders of the cardiac rhythm requiring an anti-asynchronous treatment (except beta blockers or digoxine within the framework of a chronic auricular fibrillation), unstable coronaropathy or myocardial infarction < 6 months, congestive cardiac failure > Rank II NYHA (Grade 2), uncontrolled arterial hypertension
- •Previous epilepsy crises requiring long term antiepileptic treatment Previous organ transplant requiring immunosuppressor treatment Severe bacterial or fungus infection (> Grade 2 NCI CTC version 3) Known HIV Infection
- •Long term treatment by known inductors of the CYP 3A4 like Rifampicin, Millepertuis (hypericum perforatum), Phenytoin, Carbamazepin, Phenobarbital, Dexamethasone et Ketonazole
- •Known allergy to one of the therapeutic agents
- •Reasons (psychological, family, social or geographical) that could compromise the participation of the patient in the study
- •Intestinal malabsorption or gastro-intestinal surgery being able to affect Sorafenib absorption. Occlusive or sub-occlusive syndrome.
- •Dysphagic patient or patient not being able to take treatment by orally inflammatory
- •Chronic digestive disease involving chronic diarrhoea (NCI N+Bethesda >= 1.2g)
- •Participation in another clinical trial within 30 days before the start of this study
- •Other concomitant experimental drugs or other concomitant anticancer agents (except Irinotecan and Sorafenib)
- •Medical or psychological state that in the opinion of the investigator will not allow the patient to terminate the study or to understand and sign the informed consent form
- •Pregnancy and breast-feeding
研究组 & 干预措施
Sorafenib and irinotecan
Experimental
干预措施: Nexavar (Sorafenib) and irinotecan (Campto) (Drug)
结局指标
主要结局
disease control
时间窗: 6 months
次要结局
- Assessment of adverse events by using the NCI-CTCAE version 3 scale(6 months)
- progression free survival(24 months)
- overall survival(36 months)
研究者
研究点 (5)
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