Clinical trial NCT02316496 (phase 2, status: terminated)
Conditions: colorectal cancer metastatic
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: cetuximab, irinotecan
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
Eligibility criteria:

        Inclusion Criteria:

          -  Signed and dated informed consent

          -  Histologically confirmed metastatic adenocarcinoma of the colon or rectum

          -  All Wild Type KRAS (exon 2 [codons 12-13], exon 3 [codons - 61]; exon 4 [codon 146]),
             NRAS (exon 2 [ codons 12-13] and exon 3 [codon 61) and BRAF (V600E) tumor ( local
             assessment performed either on primary tumor or metastasis)

          -  First line chemotherapy regimen with a fluoropyrimidine and Irinotecan (FOLFIRI) +
             cetuximab with initial partial or complete response and progressive disease (PD) with
             PD ≤ 6 weeks after the last administration of cetuximab

          -  Other line(s) of therapy(ies) including the following drugs: second line oxaliplatin
             based chemotherapy with fluoropyrimidines (5FU or capecitabine) + bevacizumab and
             eventually regorafenib (possible but not mandatory) and progression or limiting
             toxicity to the last therapy with a minimum of 4 months between last injection of
             cetuximab and inclusion in this study

          -  At least one measurable lesion ≥ 10 mm as assessed by CT-scan or MRI (Magnetic
             Resonance Imaging) according to RECIST v1.1 (All sites must be evaluated ≤ 28 days
             prior to the enrolment)

          -  Age ≥18 years

          -  World Health Organization (WHO) Performance status (PS) 0-2

          -  The patient has adequate organ function, defined as :

        Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, hemoglobin ≥ 9 g/dL, and platelets ≥ 100 x
        109/L.Total bilirubin ≤ 1.5 times upper limit of normal value (ULN), serum alkaline
        phosphatase level < 5 times ULN, Serum creatinine level <150μM/l

          -  For female patients of childbearing potential, negative pregnancy test within 7 days
             before starting the study drug

          -  Men and women are required to use adequate birth control during the study (when
             applicable) and until 6 months after the end of study treatment

          -  Registration in a national health care system (CMU included)

        Exclusion Criteria:

          -  Previous chemotherapy other than adjuvant therapy with different combinations than
             those scheduled in first and second line treatment

          -  Presence of any KRAS, BRAF or NRAS mutation by allelic discrimination on tumor DNA

          -  Significant cardiovascular disease including unstable angina or myocardial infarction
             within 12 months before initiation of study treatment or a history of ventricular
             arrhythmia (treated or not)

          -  History or evidence of central nervous system metastasis (systematic CT-scan or MRI
             not mandatory if no clinical symptoms)

          -  Known allergy or hypersensitivity to cetuximab

          -  Previous or concurrent malignancy except for basal or squamous cell skin cancer, in
             situ carcinoma of the cervix, low-risk prostate cancer according to d'Amico
             classification or other solid tumors treated curatively and without evidence of
             recurrence for at least 5 years prior to the study

          -  Active or uncontrolled clinically serious infection

          -  Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency
             syndrome (AIDS)-related illness

          -  Other serious and uncontrolled non-malignant disease

          -  Pregnancy

          -  Breast feeding

          -  Treatment with any other investigational medicinal product within 28 days prior to
             study entry

          -  Known Gilbert's syndrome

          -  Concomitant administration of live, attenuated virus vaccine such as yellow fever
             vaccine

          -  Concomitant use with St John's Wort

          -  Chronic inflammatory bowel disease and/or Bowel obstruction