A phase II study evaluating the use of concurrent cetuximab, irinotecan, oxaliplatin and UFT in the first line treatment of patients with metastatic colorectal cancer - e-SCOUT

The Christie NHS Foundation Trust0 个研究点目标入组 0 人开始时间: 2007年10月10日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•- Histologically confirmed colorectal adenocarcinoma
•- Patients must not have a mutation of K-ras
•- Inoperable metastatic or locoregional disease
•- No previous chemotherapy for established metastatic disease (adjuvant chemotherapy must have been completed > 6 months prior to trial entry.
•- Measurable / evaluable disease
•- Normal haematology
•- Adequate renal function
•- Adequate liver funtion
•- Karnofsky performance status 70-100
•- Negative pregnancy test for women of child-bearing potential
•- Patients must give written, informed consent
•- Life expectancy of at least 3 months
•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

•- Patients that have a K-ras mutation
•- Concurrent uncontrolled medical illness, or other previous / current malignant disease likely to interfere with protocol treatments or comparisons
•- Partial / complete bowel obstruction
•- Prior EFGR therapy
•- Age < 18
•- Chronic diarrhoea or inflammatory bowel disease
•- Known DPD deficiency
•- Gilbert's syndrome or other congenital abnormality of biliary transport
•- Previous translant surgery requiring immunosuppressive therapy
•- Regular / uncontrolled angina or cardiac arrhythmias
•- Clinically relevant coronary heart disease. History of myocardial infarction in last 12 months
•- Previous investigational agent in last 4 weeks
•- Metastatic disease to brain
•- Pregnant/lactating women
•- Patients receiving therapy with haloginated antiviral drugs
•- Patients who have experienced life-threatening toxicities with fluoropyrimidines
•- Patients suffering from any conditions which may affect absorption of UFT / folinic acid
•- Patients with known deficiency of or are on inhibitors of cytochrome P450 2A6
•- Patients who have previously had radiotherapy to the abdomen / pelvis in last 6 months
•- Any medical / psychological condition that in the opinion of the investigator would not enable the patient to complete the study or knowingly give informed consent

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