Larotaxel Compared To Continuous Administration of 5-FU in Advanced Pancreatic Cancer Patients Previously Treated With A Gemcitabine-Containing Regimen
NCT ID: NCT00417209
Last Updated: 2016-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
408 participants
INTERVENTIONAL
2006-12-31
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Larotaxel (XRP9881)
Larotaxel (XRP9881)
administered as a 1-hour IV infusion on Day 1 of every 3 weeks (q3w)
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.
5-Fluorouracil
administered as IV infusion from Day 1 to Day 4
Capecitabine
administered orally from Day 1 to Day 14 q3w
Interventions
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Larotaxel (XRP9881)
administered as a 1-hour IV infusion on Day 1 of every 3 weeks (q3w)
5-Fluorouracil
administered as IV infusion from Day 1 to Day 4
Capecitabine
administered orally from Day 1 to Day 14 q3w
Eligibility Criteria
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Inclusion Criteria
* Patient must be previously treated with a systemic gemcitabine based regimen
* Adequate bone marrow, kidney and liver functions
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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ICD
Role: STUDY_DIRECTOR
Sanofi
Locations
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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
Sanofi-Aventis Administrative Office
Mumbai, , India
Sanofi-Aventis Administrative Office
Milan, , Italy
Sanofi-Aventis Administrative Office
México, , Mexico
Sanofi-Aventis Administrative Office
Lysaker, , Norway
Sanofi-Aventis Administrative Office
Lima, , Peru
Sanofi-Aventis Administrative Office
Warsaw, , Poland
Sanofi-Aventis Administrative Office
Moscow, , Russia
Sanofi-Aventis Administrative Office
Brastislava, , Slovakia
Sanofi-Aventis Administrative Office
Madrid, , Spain
Sanofi-Aventis Administrative Office
Istanbul, , Turkey (Türkiye)
Sanofi-Aventis Administrative Office
Guildford, Surrey, , United Kingdom
Countries
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Other Identifiers
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EUDRACT: 2006-003086-14
Identifier Type: -
Identifier Source: secondary_id
EFC6596
Identifier Type: -
Identifier Source: org_study_id
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