NCT00417209

Larotaxel Compared To Continuous Administration of 5-FU in Advanced Pancreatic Cancer Patients Previously Treated With A Gemcitabine-Containing Regimen

A Randomized, Open Label Multi-Center Study Of Single Agent Larotaxel (XRP9881) Compared To Continuous Administration of 5-FU For The Treatment Of Patients With Advanced Pancreatic Cancer Previously Treated With A Gemcitabine-Containing Regimen

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 408 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy and the safety Larotaxel administered as single agent every 3 weeks to continuous administration of 5-FU every 3 weeks, in patients with advanced pancreatic cancer (non operable in a curative intent, locally recurrent or metastatic) previously treated with gemcitabine based therapy.

Conditions

• Pancreatic Neoplasms

Interventions

Type	Name	Description
DRUG	Larotaxel (XRP9881)	administered as a 1-hour IV infusion on Day 1 of every 3 weeks (q3w)
DRUG	5-Fluorouracil	administered as IV infusion from Day 1 to Day 4
DRUG	Capecitabine	administered orally from Day 1 to Day 14 q3w

Timeline

• Start date: 2006-12-01
• Primary completion: 2009-07-01
• Completion: 2009-11-01
• First posted: 2006-12-29
• Last updated: 2016-06-03

Locations

21 sites across 21 countries: United States, Belgium, Brazil, Canada, Chile, Colombia, Czechia, Finland, Germany, Hungary, India, Italy, Mexico, Norway, Peru, Poland, Russia, Slovakia, Spain, Turkey (Türkiye), United Kingdom