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

Phase 3

Terminated

• Conditions: Pancreatic Neoplasm; Neoplasm Metastasis
• Interventions: Drug: 5-Fluorouracil; Drug: S-1

• Registration Number: NCT00602745
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-01-16
• Study First Submitted QC: 2008-01-16
• Study First Posted: 2008-01-28
• Study Start: 2008-02
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2016-04
• Disposition First Submitted: 2016-04-27
• Disposition First Submitted QC: 2016-04-27
• Last Update Submitted: 2016-04-27
• Disposition First Posted: 2016-05-26
• Last Update Posted: 2016-05-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5-Fluorouracil	5-Fluorouracil	-
S-1	S-1	-

Primary Outcome Measures

Name	Time	Method
Overall Survival	study period

Secondary Outcome Measures

Name	Time	Method
Clinical Benefit assessed by Time to Symptoms Worsening (TTSW)	every 6 weeks
Progression Free Survival	every 6 weeks
Overall Response Rate according to RECIST criteria	every 6 weeks

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇹🇳 Megrine, Tunisia