Clinical trial NCT01163396 (phase 2, status: completed)
Conditions: colorectal cancer metastatic
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: bevacizumab, irinotecan, oxaliplatin, 5-fluorouracil/leucovorin
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, 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=CNC(=O)NC1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed colorectal adenocarcinoma

          -  Unresectable and measurable metastatic disease (RECIST criteria)

          -  Male or female, aged > 18 years and ≤ 75 years

          -  ECOG Performance Status (PS) < 2 if aged < 71 years

          -  ECOG PS = 0 if aged 71-75 years

          -  Life expectancy of more than 3 months

          -  Adequate haematological function: ANC ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L, Hb ≥ 9
             g/dL

          -  INR ≤ 1.5 and aPTT ≤ 1.5 x ULN within 7 days prior to starting study treatment

          -  Adequate liver function: serum bilirubin ≤ 1.5 x ULN; alkaline phosphatase and
             transaminases ≤ 2.5 x ULN (in case of liver metastases < 5 x ULN)

          -  Serum Creatinine ≤ 1.5 x ULN

          -  Urine dipstick for proteinuria < 2+. If urine dipstick is ≥ 2+, 24- hour urine must
             demonstrate ≤ 1 g of protein in 24 hours

          -  Previous adjuvant chemotherapy is allowed if more than 12 months have elapsed between
             the end of adjuvant therapy and first relapse

          -  At least 6 weeks from prior radiotherapy and 4 weeks from surgery

        Exclusion Criteria:

          -  Prior palliative chemotherapy

          -  Prior treatment with bevacizumab

          -  Bowel obstruction (or subobstruction)

          -  History of inflammatory enteropathy or extensive intestinal resection (> hemicolectomy
             or extensive small intestine resection with chronic diarrhea)

          -  Symptomatic peripheral neuropathy > 2 grade NCIC-CTG criteria

          -  Presence or history of CNS metastasis

          -  Active uncontrolled infections

          -  Active disseminated intravascular coagulation

          -  Major surgical procedure, open biopsy or significant traumatic injury within 28 days
             prior to treatment, or anticipation of the need for major surgery during the course of
             the study

          -  Central Venous Access Device (CVAD) for chemotherapy administration inserted within 2
             days prior to study treatment start

          -  Past or current history of malignancies other than colorectal carcinoma, except for
             curatively treated basal and squamous cell carcinoma of the skin cancer or in situ
             carcinoma of the cervix

          -  Clinically significant cardiovascular disease, for example cerebrovascular accidents
             (CVA) (≤ 6 months before treatment start), myocardial infarction (≤ 6 months before
             treatment start), unstable angina, NYHA ≥ grade 2 chronic heart failure (CHF),
             uncontrolled arrhythmia

          -  Uncontrolled hypertension

          -  24-hour urine protein > 1 g if dipstick > 2+

          -  History of thromboembolic or hemorrhagic events within 6 months prior to treatment

          -  Evidence of bleeding diathesis or coagulopathy

          -  Serious, non healing wound/ulcer or serious bone fracture

          -  No therapeutic anticoagulation or antiplatelet agents or NSAID with anti-platelet
             activity (aspirin ≤ 325 mg/day allowed)

          -  Pregnancy or lactation

          -  Fertile women (< 2 years after last menstruation) and men of childbearing potential
             not willing to use effective means of contraception