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

Completed · Phase 3

Conditions studied: Pancreatic Neoplasms

In brief

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.

Key facts

Study ID

NCT00417209

Run by

Sanofi

People needed

408

Starts

2006-12-01

Expected to finish

2009-11-01

Last updated by the study team

2016-06-03

Who can join

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

You may qualify if…

• Advanced (non operable in a curative intent, locally recurrent or metastatic disease) Cytologically or histologically proven epithelial cancer (adenocarcinoma) of the exocrine pancreas.
• Patient must be previously treated with a systemic gemcitabine based regimen
• Adequate bone marrow, kidney and liver functions

You may not qualify if…

• ECOG performance status (PS) of 2-3-4.
• Prior locoregional radiotherapy for pancreatic cancer.
• Symptomatic brain metastases or leptomeningeal disease.
• Any serious intercurrent infections, uncontrolled cardiac or gastro-intestinal diseases.
• Other concurrent malignancy
• Other protocol-defined exclusion/inclusion criteria may apply

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
• Sanofi-Aventis Administrative Office — Diegem, Belgium
• Sanofi-Aventis Administrative Office — São Paulo, Brazil
• Sanofi-Aventis Administrative Office — Laval, Quebec, Canada
• Sanofi-Aventis Administrative Office — Santiago, Chile
• Sanofi-Aventis Administrative Office — Bogotá, Colombia
• Sanofi-Aventis Administrative Office — Prague, Czechia
• Sanofi-Aventis Administrative Office — Helsinki, Finland
• Sanofi-Aventis Administrative Office — Berlin, Germany
• Sanofi-Aventis Administrative Office — Budapest, Hungary
• Sanofi-Aventis Administrative Office — Mumbai, India
• Sanofi-Aventis Administrative Office — Milan, Italy
• Sanofi-Aventis Administrative Office — México, Mexico
• Sanofi-Aventis Administrative Office — Lysaker, Norway
• Sanofi-Aventis Administrative Office — Lima, Peru
• Sanofi-Aventis Administrative Office — Warsaw, Poland
• Sanofi-Aventis Administrative Office — Moscow, Russia
• Sanofi-Aventis Administrative Office — Brastislava, Slovakia
• Sanofi-Aventis Administrative Office — Madrid, Spain
• Sanofi-Aventis Administrative Office — Istanbul, Turkey (Türkiye)
• Sanofi-Aventis Administrative Office — Guildford, Surrey, United Kingdom

Full record on ClinicalTrials.gov

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