Clinical trial NCT00394992 (phase 3, status: terminated)
Conditions: colorectal cancer, liver metastases
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, Z52.6, K71.8, K71.7, A06.4, C22.0, C22.3, K70.0
Drugs: oxaliplatin+capecitabine, oxaliplatin+capecitabine+bevacizumab
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    data from the c08 study and avant study
  
Eligibility criteria:

        Inclusion Criteria:

          -  Signed written informed consent obtained prior to any study-specific procedures.

          -  Age ≥ 18 years.

          -  Liver metastases radically resected (R0 resection).

          -  Study medication started ≥4 and ≤ 8 weeks post liver surgery.

          -  Histologically confirmed liver metastasis of colorectal cancer after surgery.

          -  ECOG performance status 0 or 1.

          -  Adequate hematology: ANC ≥1.5 x 109/L, platelets ≥100 x 109/L, Hb ≥5.5 mmol/L, INR ≤
             1.5, APTT < 1.5 X UNL.

          -  Adequate biochemistry: total bilirubin ≤1.5 UNL, ASAT and ALAT ≤2.5 x UNL, alkaline
             phosphatase ≤2.5 x UNL, serum creatinine ≤1.5 UNL.

          -  Urine dipstick <2+ for protein.

        Exclusion Criteria:

          -  Extrahepatic metastatic disease.

          -  Prior adjuvant chemotherapy given <6 months prior to detection of the liver
             metastases.

          -  Prior non colorectal malignancies.

          -  Bleeding diathesis or coagulation disorders or the need for full-dose anticoagulation.

          -  Major surgical procedure <4 weeks prior to start of study treatment.

          -  Females with a positive pregnancy test (within 14 days before treatment start) .

          -  Lactating women.

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

          -  History of psychiatric disability judged by the investigator to be clinically
             significant, precluding informed consent or interfering with compliance for oral drug
             intake.

          -  Clinically significant (i.e. active) cardiovascular disease e.g. cerebrovascular
             accidents (≤6 months prior to randomization), myocardial infarction (≤1 year prior to
             randomization), uncontrolled hypertension while receiving chronic medication, unstable
             angina, New York Heart Association (NYHA) Grade II or greater congestive heart
             failure, or serious cardiac arrhythmia requiring medication.

          -  Lack of physical integrity of the upper gastrointestinal tract, malabsorption
             syndrome, or inability to take oral medication.

          -  Known peripheral neuropathy, including oxaliplatin induced neuropathy > grade Absence
             of deep tendon reflexes as the sole neurological abnormality does not render the
             patient ineligible.

          -  Organ allografts requiring immunosuppressive therapy.

          -  Serious, non-healing wound, ulcer, or bone fracture.

          -  Current or recent (within 10 days prior to study treatment start) use of full-dose
             oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes.

          -  Chronic, daily treatment with high-dose asprin (> 325 mg/day) or nonsteroidal
             anti-inflammatory medications (those known to inhibit platelet function at doses used
             to treat chronic inflammatory diseases). Patients can be rendered eligible by changing
             the treatment to COX II inhibitors.

          -  Chronic treatment with corticosteroids (dose of ≥ 10 mg/day methylprednisolone
             equivalent excluding inhaled steroids).

          -  Serious intercurrent infections (uncontrolled or requiring treatment).

          -  Current or recent (within the 28 days prior to randomization) treatment with another
             investigational drug or participation in another investigational study.

          -  Patients with known allergy to Chinese hamster Ovary cell proteins or other
             recombinant human or humanized antibodies or to any excipients of bevacizumab
             formulation, platinum compounds or to any other component of the study drugs.