Larotaxel Compared To Continuous Administration of 5-FU in Advanced Pancreatic Cancer Patients Previously Treated With A Gemcitabine-Containing Regimen (PAPRIKA)
Primary Purpose
Pancreatic Neoplasms
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Larotaxel (XRP9881)
5-Fluorouracil
Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Neoplasms focused on measuring advanced pancreatic cancer
Eligibility 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
Sites / Locations
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Larotaxel (XRP9881)
5-Fluorouracil or capecitabine
Arm Description
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.
Outcomes
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
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;
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00417209
Brief Title
Larotaxel Compared To Continuous Administration of 5-FU in Advanced Pancreatic Cancer Patients Previously Treated With A Gemcitabine-Containing Regimen
Acronym
PAPRIKA
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 Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasms
Keywords
advanced pancreatic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
408 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Larotaxel (XRP9881)
Arm Type
Experimental
Arm Title
5-Fluorouracil or capecitabine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Larotaxel (XRP9881)
Intervention Description
administered as a 1-hour IV infusion on Day 1 of every 3 weeks (q3w)
Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil
Intervention Description
administered as IV infusion from Day 1 to Day 4
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
administered orally from Day 1 to Day 14 q3w
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Sanofi-Aventis Administrative Office
City
Diegem
Country
Belgium
Facility Name
Sanofi-Aventis Administrative Office
City
Sao Paulo
Country
Brazil
Facility Name
Sanofi-Aventis Administrative Office
City
Laval, Quebec
Country
Canada
Facility Name
Sanofi-Aventis Administrative Office
City
Santiago de Chile
Country
Chile
Facility Name
Sanofi-Aventis Administrative Office
City
Santafe de Bogota
Country
Colombia
Facility Name
Sanofi-Aventis Administrative Office
City
Praha
Country
Czech Republic
Facility Name
Sanofi-Aventis Administrative Office
City
Helsinki
Country
Finland
Facility Name
Sanofi-Aventis Administrative Office
City
Berlin
Country
Germany
Facility Name
Sanofi-Aventis Administrative Office
City
Budapest
Country
Hungary
Facility Name
Sanofi-Aventis Administrative Office
City
Mumbai
Country
India
Facility Name
Sanofi-Aventis Administrative Office
City
Milan
Country
Italy
Facility Name
Sanofi-Aventis Administrative Office
City
Mexico
Country
Mexico
Facility Name
Sanofi-Aventis Administrative Office
City
Lysaker
Country
Norway
Facility Name
Sanofi-Aventis Administrative Office
City
Lima
Country
Peru
Facility Name
Sanofi-Aventis Administrative Office
City
Warszawa
Country
Poland
Facility Name
Sanofi-Aventis Administrative Office
City
Moscow
Country
Russian Federation
Facility Name
Sanofi-Aventis Administrative Office
City
Brastislava
Country
Slovakia
Facility Name
Sanofi-Aventis Administrative Office
City
Madrid
Country
Spain
Facility Name
Sanofi-Aventis Administrative Office
City
Istanbul
Country
Turkey
Facility Name
Sanofi-Aventis Administrative Office
City
Guildford, Surrey
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Larotaxel Compared To Continuous Administration of 5-FU in Advanced Pancreatic Cancer Patients Previously Treated With A Gemcitabine-Containing Regimen
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