S-1 Versus 5-FU Bolus in Metastatic Pancreatic Cancer Patients Previously Treated With Gemcitabine-Based Regimen

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

The primary objective of this study is to determine whether S-1 increases overall survival when compared to 5-Fluorouracil (5-FU) in patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy.

The secondary objectives are to compare: progression free survival, overall response rate, clinical benefit and improvement in tumor related symptoms and also to assess overall safety and pharmacokinetics of S-1.

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
• Eastern Cooperative Oncology Group (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 fluoropyrimidines
• 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.