Clinical trial NCT01121848 (phase 3, status: completed)
Conditions: pancreatic neoplasms
ICD codes: C25.3
Drugs: leucovorin, oxaliplatin, 5-fluorouracil
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, FC1=CNC(=O)NC1=O
Eligibility criteria:

        Inclusion criteria:

          -  Histologically or cytologically proven pancreatic carcinoma

          -  Measurable locally advanced or metastatic disease

          -  Patient previously treated with 5-FU as a "radiation sensitizer" and all toxicities
             must have been resolved

          -  Patients must have received Gemcitabine-based chemotherapy (single agent or
             combination) as 1st line therapy for advanced or metastatic disease and all toxicities
             must have been resolved

          -  Patients received the last dose of gemcitabine at least 2 weeks prior to randomization

          -  Confirmed radiographic disease progression (Computed Tomogram (CT) scan or Magnetic
             Resonance Imaging (MRI) within 4 weeks prior to randomization

          -  Adequate liver and kidney function:

               -  Total bilirubin inferior than 1.5 Upper Limit of Normal (ULN)

               -  Creatinine clearance (ClCr) superior than 50 mL / min

               -  Aspartate Transferase (AST) inferior than 3 ULN if no liver metastasis or AST
                  inferior than 5 ULN if liver metastasis

               -  Alanine Aminotransferase (ALT) inferior than 3 ULN if no liver metastasis or ALT
                  inferior than 5 ULN if liver metastasis

          -  Adequate hematological function:

               -  Neutrophils superior or egal to 1.5 x 109/L

               -  Platelets superior or egal to 100 x 109/L

        Exclusion criteria:

          -  Peripheral sensory or motor neuropathy > grade 1

          -  Eastern Cooperative Oncology Group (ECOG) Performance status > 2

          -  Serious cardiac arrhythmia, diabetes, or serious active infection or other active
             illness that would preclude study participation in the opinion of the investigator

          -  Pernicious anemia or other megaloblastic anemia with vitamin B12 deficiency

          -  Previous (greater than 5 years) or current malignancies of other origin within the
             past 5 years

          -  Lack of physical integrity of the upper gastrointestinal tract, clinically significant
             malabsorption syndrome, or inability to take oral medications

          -  History of known allergy to oxaliplatin or other platinum compounds, to 5-FU, to LV or
             to any ingredients in the formulations or the containers

          -  Severe renal impairment (ClCr < 50 mL/min)

          -  Pregnant women or breast-feeding

          -  Patients (male or female) with reproductive potential not implementing accepted and
             effective method of contraception (the definition of "effective method of
             contraception" will be based on the investigators' judgment)

        The above information is not intended to contain all considerations relevant to a patient's
        potential participation in a clinical trial.