Advanced, inoperable or metastatic colorectal cancer.
Conditions
Interventions
Trade Name: Erbitux 5mg/ml
Product Name: Cetuximab
Product Code: EMD271786
Pharmaceutical Form: Solution for infusion
Sponsors
The Christie NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the response rate (RR), using the RECIST criteria, of patients with locally advanced / metastatic colorectal cancer treated with a combination of irinotecan, oxaliplatin, UFT and cetuximab.; Secondary Objective: To assess: - Progression-free survival (PFS) - Overall survival (OS; all causes of death) - Toxicity - Resectability of liver, lung and pelvic disease after chemotherapy - Time to progression (TTP) ; Primary end point(s): The primary end point is the objective response rate as measured by RECIST criteria. Chemotherapy should be given for 8 weeks (2 cycles) prior to assessment. - In patients who respond or develop stable disease, the treatment should be continued for a further 8 weeks (16 weeks in total). - In patients who respond or develop stable disease, the treatment should be continued for a further 8 weeks (24 weeks in total). - If a patient contiunes to respond or maintain stable disease after 24 weeks of treatment, then the treatment can be contiunued until disease progression (if cumulative toxicity is not a problem) at the discretion of the investigator in agreement with the individual patient. | — |
Countries
United Kingdom
Outcome results
None listed