- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00417209
Larotaxel Compared To Continuous Administration of 5-FU in Advanced Pancreatic Cancer Patients Previously Treated With A Gemcitabine-Containing Regimen (PAPRIKA)
May 3, 2016 updated by: Sanofi
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
408
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Diegem, Belgium
- Sanofi-Aventis Administrative Office
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Sao Paulo, Brazil
- Sanofi-Aventis Administrative Office
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Laval, Quebec, Canada
- Sanofi-Aventis Administrative Office
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Santiago de Chile, Chile
- Sanofi-Aventis Administrative Office
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Santafe de Bogota, Colombia
- Sanofi-Aventis Administrative Office
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Praha, Czech Republic
- Sanofi-Aventis Administrative Office
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Helsinki, Finland
- Sanofi-Aventis Administrative Office
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Berlin, Germany
- Sanofi-Aventis Administrative Office
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Budapest, Hungary
- Sanofi-Aventis Administrative Office
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Mumbai, India
- Sanofi-Aventis Administrative Office
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Milan, Italy
- Sanofi-Aventis Administrative Office
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Mexico, Mexico
- Sanofi-Aventis Administrative Office
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Lysaker, Norway
- Sanofi-Aventis Administrative Office
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Lima, Peru
- Sanofi-Aventis Administrative Office
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Warszawa, Poland
- Sanofi-Aventis Administrative Office
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Moscow, Russian Federation
- Sanofi-Aventis Administrative Office
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Brastislava, Slovakia
- Sanofi-Aventis Administrative Office
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Madrid, Spain
- Sanofi-Aventis Administrative Office
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Istanbul, Turkey
- Sanofi-Aventis Administrative Office
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Guildford, Surrey, United Kingdom
- Sanofi-Aventis Administrative Office
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New Jersey
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Bridgewater, New Jersey, United States, 08807
- Sanofi-Aventis Administrative Office
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Larotaxel (XRP9881)
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administered as a 1-hour IV infusion on Day 1 of every 3 weeks (q3w)
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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.
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administered as IV infusion from Day 1 to Day 4
administered orally from Day 1 to Day 14 q3w
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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study period
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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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
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study period
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
December 28, 2006
First Submitted That Met QC Criteria
December 28, 2006
First Posted (Estimate)
December 29, 2006
Study Record Updates
Last Update Posted (Estimate)
June 3, 2016
Last Update Submitted That Met QC Criteria
May 3, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Fluorouracil
- Capecitabine
Other Study ID Numbers
- EFC6596
- EUDRACT: 2006-003086-14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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