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

COMPLETEDPHASE3

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

NCT00417209•Sanofi

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•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

Exclusion Criteria

•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

Locations (21)

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

Key Dates

Start Date

December 1, 2006

Primary Completion Date

July 1, 2009

Completion Date

November 1, 2009

Last Updated

June 3, 2016

Enrollment

408

ACTUAL participants

Conditions

Pancreatic Neoplasms

Interventions

Larotaxel (XRP9881)

DRUG

5-Fluorouracil

DRUG

Capecitabine

DRUG

Sponsors

Lead Sponsor

Sanofi

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 3, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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