Clinical trial NCT00675012 (phase 2, status: completed)
Conditions: colon cancer
ICD codes: C18.2, C18.4, C18.6, C18.7, C18.9, D12.2, D12.3
Drugs: ngr-htnf, oxaliplatin, capecitabine
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
Eligibility criteria:

        Inclusion Criteria:

          -  Patients ≥ 18 years with metastatic colorectal cancer (CRC) treated with no more than
             three standard systemic regimens (including biologic agents) for metastatic disease

          -  Life expectancy more than 3 months

          -  ECOG Performance status 0-1

          -  Adequate baseline bone marrow, hepatic and renal function, defined as follows:

               -  Neutrophils >1.5 x 10^9/L and platelets > 100 x 10^9/L

               -  Bilirubin <1.5 x ULN

               -  AST and/or ALT <2.5 x ULN in absence of liver metastasis

               -  AST and/or ALT <5 x ULN in presence of liver metastasis

               -  Serum creatinine <1.5 x ULN

               -  Creatinine clearance (estimated according to Cockcroft-Gault formula) ≥ 50 ml/min

          -  Patients may have had prior therapy providing the following conditions are met:

               -  Chemotherapy, radiation therapy, hormonal therapy or immunotherapy: wash-out
                  period of 28 days before start treatment

               -  Surgery: wash-out period of 14 days before start treatment

          -  Patients must give written informed consent to participate in the study

        Exclusion Criteria:

          -  Concurrent anticancer therapy

          -  Patients must not receive any other investigational agents while on study

          -  Patients with myocardial infarction within the last six (6) months, unstable angina,
             New York Heart Association (NYHA) grade II or greater congestive heart failure, or
             serious cardiac arrhythmia requiring medication

          -  Uncontrolled hypertension

          -  Prolonged QTc interval (congenital or acquired)

          -  Patient with significant peripheral vascular disease

          -  Clinical signs of CNS involvement

          -  Patients with active or uncontrolled systemic disease/infections or with serious
             illness or medical conditions, which is incompatible with the protocol

          -  Symptomatic peripheral neuropathy ≥ grade 1 according the NCI CTCAE v.3.0.

          -  Known hypersensitivity/allergic reaction or contraindications to human albumin
             preparations or to any of the excipients

          -  Known hypersensitivity/allergic reaction or contraindications to platinum compounds or
             fluoropyrimidines

          -  Any psychological, familial, sociological or geographical condition potentially
             hampering compliance with the study protocol

          -  Pregnancy or lactation.

          -  Patients - both males and females - with reproductive potential (i.e. menopausal for
             less than 1-year and not surgically sterilized) must practice effective contraceptive
             measures throughout the study.

          -  Women of childbearing potential must provide a negative pregnancy test (serum or
             urine) within 14 days prior to registration