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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00417209
Recruitment Status : Completed
First Posted : December 29, 2006
Last Update Posted : June 3, 2016
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Pancreatic Neoplasms Drug: Larotaxel (XRP9881) Drug: 5-Fluorouracil Drug: Capecitabine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 408 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Larotaxel (XRP9881) Drug: Larotaxel (XRP9881)
administered as a 1-hour IV infusion on Day 1 of every 3 weeks (q3w)

Active Comparator: 5-Fluorouracil or 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.
Drug: 5-Fluorouracil
administered as IV infusion from Day 1 to Day 4

Drug: Capecitabine
administered orally from Day 1 to Day 14 q3w

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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
  • Other protocol-defined exclusion/inclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00417209

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United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sanofi-Aventis Administrative Office
Diegem, Belgium
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Sanofi-Aventis Administrative Office
Laval, Quebec, Canada
Sanofi-Aventis Administrative Office
Santiago de Chile, Chile
Sanofi-Aventis Administrative Office
Santafe de Bogota, Colombia
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
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
Mexico, Mexico
Sanofi-Aventis Administrative Office
Lysaker, Norway
Sanofi-Aventis Administrative Office
Lima, Peru
Sanofi-Aventis Administrative Office
Warszawa, Poland
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Sanofi-Aventis Administrative Office
Brastislava, Slovakia
Sanofi-Aventis Administrative Office
Madrid, Spain
Sanofi-Aventis Administrative Office
Istanbul, Turkey
United Kingdom
Sanofi-Aventis Administrative Office
Guildford, Surrey, United Kingdom
Sponsors and Collaborators
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Study Director: ICD Sanofi
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Responsible Party: Sanofi Identifier: NCT00417209    
Other Study ID Numbers: EFC6596
EUDRACT: 2006-003086-14
First Posted: December 29, 2006    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: May 2016
Keywords provided by Sanofi:
advanced pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs