A Multicenter, Open-Label, Randomized Study Comparing Efficacy and Safety of S-1 as Single Agent Versus 5-FU Bolus for the Treatment of Patients With Metastatic Pancreatic Cancer Previously Treated With a Gemcitabine-Based Regimen

Inclusion Criteria:

- Cytologically or histologically confirmed evidence of adenocarcinoma of the exocrine
pancreas

- Metastatic disease previously treated with a gemcitabine-based regimen

Exclusion Criteria:

- Locally advanced disease

- More than one prior chemotherapy-line for advanced pancreatic disease

- Prior treatment with fluoropyrimidines for advanced pancreatic cancer

- ECOG performance status >or= 2

- Poor kidney, liver or bone marrow functions

- Any serious active disease or co-morbid condition, which in the opinion of the
principle investigator, will interfere with the safety or with compliance with the
study

- Unable to swallow capsules

- Hypersensitivity history to any of the constituents of the study medications or
fluoropyrimides

- Concurrent participation in another clinical trial or treatment with any other
anticancer therapy

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