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
- Conditions
- Advanced, inoperable or metastatic colorectal cancer.
- Registration Number
- EUCTR2007-002053-24-GB
- Lead Sponsor
- The Christie NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method