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

Phase 3

Completed

• Conditions: Pancreatic Neoplasms
• Interventions: Drug: Larotaxel (XRP9881); Drug: 5-Fluorouracil; Drug: Capecitabine

• Registration Number: NCT00417209
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2006-12-28
• Study First Submitted QC: 2006-12-28
• Study First Posted: 2006-12-29
• Primary Completion: 2009-07
• Study Completion: 2009-11
• Disposition First Submitted: 2016-04-06
• Disposition First Submitted QC: 2016-04-06
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-03
• Disposition First Posted: 2016-05-04
• Last Update Posted: 2016-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 408

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
• Other protocol-defined exclusion/inclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Larotaxel (XRP9881)	Larotaxel (XRP9881)	-
5-Fluorouracil or capecitabine	5-Fluorouracil	Each Investigator must choose either IV 5-FU or oral capecitabine regimen before the first participant begins the study and has to consistently use the chosen regimen throughout the study for all participants treated at her/his site.
5-Fluorouracil or capecitabine	Capecitabine	Each Investigator must choose either IV 5-FU or oral capecitabine regimen before the first participant begins the study and has to consistently use the chosen regimen throughout the study for all participants treated at her/his site.

Primary Outcome Measures

Name	Time	Method
overall survival (OS) defined as the time interval from the date of randomization to the date of death due to any cause	study period

Secondary Outcome Measures

Name	Time	Method
Progression free survival (PFS); Overall Response Rate (proportion of patients with confirmed RECIST-defined complete response (CR) or partial response (PR); clinical benefit based on the measurement of tumor related symptoms;	study period

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇬🇧 Guildford, Surrey, United Kingdom