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

Tracking Information

First Received Date ^ICMJE

December 28, 2006

Last Updated Date

July 7, 2009

Start Date ^ICMJE

December 2006

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

overall survival (OS) defined as the time interval from the date of randomization to the date of death due to any cause [ Time Frame: study period ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

The primary efficacy endpoint is overall survival (OS) defined as the time interval from the date of randomization to the date of death due to any cause.

Change History

Complete list of historical versions of study NCT00417209 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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; [ Time Frame: study period ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Pancreatic Neoplasms

Intervention ^ICMJE

Drug: larotaxel (XRP9881)
Drug: 5-Fluorouracil

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

400

Estimated Completion Date

October 2009

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Finland, Germany, Hungary, India, Italy, Mexico, Norway, Peru, Poland, Russian Federation, Slovakia, Spain, Turkey, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00417209

Responsible Party

ICD Study Director, sanofi-aventis

Study ID Numbers ^ICMJE

EFC6596, EUDRACT: 2006-003086-14

Study Sponsor ^ICMJE

Sanofi-Aventis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

ICD

Sanofi-Aventis

Information Provided By

Sanofi-Aventis

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP