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

Stopped early · Phase 3

Conditions studied: Pancreatic Neoplasm, Neoplasm Metastasis

In brief

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.

Key facts

Study ID

NCT00602745

Run by

Sanofi

People needed

61

Starts

2008-02-01

Expected to finish

2010-03-01

Last updated by the study team

2016-05-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cytologically or histologically confirmed evidence of adenocarcinoma of the exocrine pancreas
• Metastatic disease previously treated with a gemcitabine-based regimen

You may not qualify if…

• 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.

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
• Sanofi-Aventis Administrative Office — Vienna, Austria
• Sanofi-Aventis Administrative Office — São Paulo, Brazil
• Sanofi-Aventis Administrative Office — Laval, Canada
• Sanofi-Aventis Administrative Office — San José, Costa Rica
• Sanofi-Aventis Administrative Office — Hørsholm, Denmark
• Sanofi-Aventis Administrative Office — Paris, France
• Sanofi-Aventis Administrative Office — Athens, Greece
• Sanofi-Aventis Administrative Office — Mixco, Guatemala
• Sanofi-Aventis Administrative Office — Budapest, Hungary
• Sanofi-Aventis Administrative Office — Netanya, Israel
• Sanofi-Aventis Administrative Office — Ocean Business Plaza, Panama
• Sanofi-Aventis Administrative Office — Lima, Peru
• Sanofi-Aventis Administrative Office — Bucharest, Romania
• Sanofi-Aventis Administrative Office — Midrand, South Africa
• Sanofi-Aventis Administrative Office — Bromma, Sweden
• Sanofi-Aventis Administrative Office — Mégrine, Tunisia

Full record on ClinicalTrials.gov

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