Overview

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

Status:
Terminated
Trial end date:
2010-03-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
Collaborator:
Taiho Pharmaceutical Co., Ltd.
Treatments:
Fluorouracil
Gemcitabine
Criteria
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.