Clinical trial NCT01348412 (phase 2, status: completed)
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, raltitrexed, other intravenous chemotherapy drugs
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@]12O[C@]3(CC4=CC=CC=C4)O[C@]1(C[C@@]([H])(C)[C@]1(O3)[C@]3([H])C=C(C)C(=O)[C@@]3(O)CC(COC(=O)CC3=CC(OC)=C(O)C=C3)=C[C@@]21[H])C(C)=C, CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent signature by the patient-

          -  Cover by an health insurance

          -  Age between 18 and 75 years

          -  Age between 76 et 80 years if patient WHO Status 0

          -  WHO status of 0 or 1

          -  Estimated Life expectancy > 3 months

          -  Hepatic metastases of colorectal cancer confirmed on CT Scan without extra-hepatic
             metastasis (the presence of asymptomatic primary tumor is tolerated)

          -  TEP-Scan without fixation outside the liver and the primary tumor

          -  Histological proven colorectal cancer obtained from primary tumor or the hepatic
             metastases

          -  Metastases not accessible to curative hepatectomy (impossible R0 surgery or leaving
             less than 30 % of residual liver), or requiring a complex, very wide hepatectomy (5
             segments or more) and\or risky procedure (RPC Class II)- - Presence of hepatic lesion
             > 10 mm on CTScan or hepatic MRI

          -  Failure or arrest of a previous chemotherapy because of intolerance to oxaliplatin,
             irinotecan, a fluoropyrimidine and/or target therapies (bevacizumab, cetuximab or
             panitumumab given for tumor expressing wild type Ki-Ras)

          -  Bilirubinemia< 1,5 times the superior limit of the normal ( N ),

          -  ASAT and ALAT < 5 N,

          -  Creatinemia < 1.5 N and creatinine clearance > 65ml/mn,

          -  Neutrophils > 1,5 x 109/L, platelets 100 x 109/L, hemoglobin > 9 g/dL (patients
             includables even after red blood cell transfusion)-Reference CTScan +/-MRI performed
             in 21 days preceding the first cycle of treatment

        Exclusion Criteria:

          -  extra-hepatic metastases (presence of 1 to 3 pulmonary nodules, of a maximal diameter
             of 5 mm with non specific aspect on CTScan and with no fixation on TEP Scan does not
             constitute a criterion of exclusion)

          -  Symptomatic primary colorectal tumor in place

          -  Contraindication for allergy of rank 3-4 for one of the compounds of chemotherapy-
             Peripheral neuropathy > 2 (Levy Scale)

          -  Current participation or in the 30 days preceding the inclusion in the study in
             another therapeutic trial with an experimental molecule

          -  Concomitant systemic treatment by immunotherapy, chemotherapy or hormonotherapy-
             Unbalanced serious illness, unchecked active infection or the other underlying serious
             disorder susceptible to prevent the patient from receiving the treatment

          -  Pregnancy (pregnancy test compulsory for the inclusion), breast-feeding

          -  Intestinal occlusion or sub-occlusion or history of inflammatory intestinal disease

          -  Other cancer during the 5 years preceding entry in the trial or concomitant (except in
             situ cancer of the cervix or skin basal cell carcinoma)Patient in custody or under
             guardianship, Impossibility to adhere to the medical follow-up for geographical,
             social or psychiatric reason