Clinical trial NCT01225744 (phase 2, status: completed)
Conditions: metastatic colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: cetuximab, irinotecan, oxaliplatin, uft
SMILES: [H][C@]12SCC(COC(C)=O)=C(N1C(=O)[C@H]2NC(=O)C(=N/OC)\C1=CSC(N)=N1)C(O)=O, CC[C@@]1(O)C(=O)OCC2=C1C=C1N(CC3=CC4=CC=CC=C4N=C13)C2=O, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, FC1=CN(C2CCCO2)C(=O)NC1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed adenocarcinoma of the colon or rectum.

          -  Patients must not have a mutation of K-ras

          -  Inoperable metastatic or locoregional disease (synchronous or recurrence)

          -  No previous chemotherapy for established metastatic disease (adjuvant chemotherapy
             must have been completed more than 6 months prior to trial entry)

          -  Measurable or evaluable disease

          -  Bone marrow function: neutrophil count >1.5 x109/l and platelet count >150 x109/l

          -  Hepatobiliary function: serum bilirubin <1.5 x upper limit of normal (ULN); ALP <5 x
             ULN; transaminase (AST or ALT) <3 x ULN.(≤ 5 if liver mets are present)

          -  Renal function: estimated creatinine clearance >50 ml/min, or measured Glomerular
             filtration rate (GFR) (EDTA or creatinine clearance) in normal range

          -  ECOG performance status 0-1 and considered fit and able to undergo all possible
             treatments

          -  For women of child-bearing potential a negative pregnancy test is required and
             adequate contraceptive precautions such as a sheath for their partner must be used

          -  For men - adequate contraception such as a sheath must be used

          -  Patients must give written, informed consent

          -  Life expectancy ≥ 3 months.

        Exclusion Criteria:

          -  Patients that have a K-ras mutation

          -  Concurrent uncontrolled medical illness, or other previous or current malignant
             disease likely to interfere with protocol treatments or comparisons

          -  Partial or complete bowel obstruction

          -  Prior EGFR antibody therapy

          -  Age <18

          -  Chronic diarrhoea or inflammatory bowel disease

          -  Known Pyruvate Dehydrogenase Phosphatase (DPD) deficiency

          -  Gilbert's syndrome or other congenital abnormality of biliary transport

          -  Previous transplant surgery, requiring immunosuppressive therapy

          -  Regular / uncontrolled angina or cardiac arrhythmias

          -  Clinically relevant coronary artery disease. History of Myocardial infarction in the
             last 12 months

          -  Previous investigational agent in the last 4 weeks

          -  Metastatic disease to brain

          -  Any pregnant or lactating women

          -  Patients receiving therapy with haloginated antiviral drugs (eg: sorivudine)

          -  Patients who have experienced life-threatening toxicities with fluoropyrimidines
             treatment

          -  Patients suffering from any condition that may affect the absorption of UFT or folinic
             acid.

          -  Patients with known deficiency of or are on inhibitors of cytochrome P450 2A6

          -  Patients who have previously had radiotherapy to the abdomen or pelvis in the last 6
             months

          -  Any medical or psychological condition that in the opinion of the investigator would
             not enable the patient to complete the study or knowingly give informed consent