Clinical trial NCT02181556 (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: folfir + aflibercept
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  Overall state as per WHO ≤ 2

          -  Life expectancy > 3 months

          -  Metastatic adenocarcinoma of the rectum or of the colon histologically proven on the
             primary tumor or a metastasis

          -  Unresectable metastasis (metastases) and/or inoperable patient

          -  Patient eligible for a 1st line treatment associating 5 FU-Irinotecan (FOLFIRI) and
             aflibercept

          -  At least one measurable target lesion according to RECIST criteria v1.1 not previously
             irradiated

          -  Absence of prior treatment of the metastatic disease. Prior adjuvant chemotherapy
             completed at least 12 months before the metastatic cancer diagnosis is authorized

          -  Satisfactory laboratory panel: Hb> 9 g/dl, polynuclear neutrophils > 1500 /mm3,
             platelets > 100,000/mm3, total bilirubin < 1.5 x LSN, creatinine clearance > 50mL/min
             (cockcroft-Gault formula - appendix 4), ALP < 5 x UNL, AST and ALT < 5 x UNL, GGT < 5
             x UNL,

          -  Proteinuria on urine dipstick < 2+. If > 2+ test 24-hour proteinuria, which should be
             < 1 g

        Exclusion Criteria:

          -  Patients whose primary tumor is in place and presenting clinical symptoms (occlusion;
             hemorrhage)

          -  Brain metastases

          -  Gilbert's syndrome

          -  Uncontrolled hypercalcemia

          -  Hypertension not kept under control (SBP >150 mmHg and DBP >100 mmHg) or history of
             hypertensive crisis or hypertensive encephalopathy

          -  Any unbalanced active disease over the last 6 months: liver failure, kidney failure,
             respiratory failure, congestive heart failure, unstable angina, myocardial infarction,
             significant arrhythmia (Patients treated by anticoagulants (coumadin, warfarin) are
             eligible if strict monitoring of the INR is possible)

          -  Significant surgical intervention within the 28 days before the start of treatment

          -  Presence of active gastroduodenal ulcer, non-healed wound or bone fracture

          -  Antitumor treatments other than those included in the study (chemotherapy, targeted
             therapy, immunotherapy)

          -  History of malignant hemopathy or cancer except for those treated more than 5 years
             ago and considered healed, in situ carcinomas of the uterine cervix and treated skin
             cancers (except for melanoma)

          -  Pregnant or breast-feeding women, women of childbearing age not having taken a
             pregnancy test, absence of effective contraception in patients (men and/or women) of
             childbearing age

          -  Any contraindication of the drugs used in the study

          -  Impossible to meet the medical follow-up requirements of the study for geographic,
             social or psychological reasons