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

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00417209

Purpose

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.

Condition	Intervention	Phase
Pancreatic Neoplasms	Drug: larotaxel (XRP9881) Drug: 5-Fluorouracil	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Fluorouracil Gemcitabine Gemcitabine hydrochloride Larotaxel

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	400
Study Start Date:	December 2006
Estimated Study Completion Date:	October 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: larotaxel (XRP9881) IV infusion
2: Active Comparator	Drug: 5-Fluorouracil administered either by IV or oral route

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417209

Hide Study Locations

Locations

United States, New Jersey
Sanofi-aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Belgium
Sanofi-aventis Administrative Office
Diegem, Belgium
Brazil
Sanofi-aventis Administrative Office
Sao Paulo, Brazil
Canada
Sanofi-aventis Administrative Office
Laval, Quebec, Canada
Chile
Sanofi-aventis Administrative Office
Santiago de Chile, Chile
Colombia
Sanofi-aventis Administrative Office
Santafe de Bogota, Colombia
Czech Republic
Sanofi-aventis Administrative Office
Praha, Czech Republic
Finland
Sanofi-aventis Administrative Office
Helsinki, Finland
Germany
Sanofi-aventis Administrative Office
Berlin, Germany
Hungary
Sanofi-aventis Administrative Office
Budapest, Hungary
India
Sanofi-aventis Administrative Office
Mumbai, India
Italy
Sanofi-aventis Administrative Office
Milan, Italy
Mexico
Sanofi-aventis Administrative Office
Mexico, Mexico
Norway
Sanofi-aventis Administrative Office
Lysaker, Norway
Peru
Sanofi-aventis Administrative Office
Lima, Peru
Poland
Sanofi-aventis Administrative Office
Warszawa, Poland
Russian Federation
Sanofi-aventis Administrative Office
Moscow, Russian Federation
Slovakia
Sanofi-aventis Administrative Office
Brastislava, Slovakia
Spain
Sanofi-aventis Administrative Office
Madrid, Spain
Turkey
Sanofi-aventis Administrative Office
Istanbul, Turkey
United Kingdom
Sanofi-aventis Administrative Office
Guildford, Surrey, United Kingdom

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC6596, EUDRACT: 2006-003086-14
Study First Received:	December 28, 2006
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00417209 History of Changes
Health Authority:	United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Sanofi-Aventis:

advanced pancreatic cancer

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Endocrine System Diseases
Enzyme Inhibitors
Antiviral Agents

Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Radiation-Sensitizing Agents
Therapeutic Uses
Fluorouracil
Pancreatic Diseases
Gemcitabine
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 30, 2009