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

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00417209

Collaborator

(none)

408

Enrollment

Locations

Arms

Duration (Months)

19.4

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

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 :

Dec 1, 2006

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

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

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

Outcome Measures

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 [study period]

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; [study period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey	United States	08807
2	Sanofi-Aventis Administrative Office	Diegem		Belgium
3	Sanofi-Aventis Administrative Office	Sao Paulo		Brazil
4	Sanofi-Aventis Administrative Office	Laval, Quebec		Canada
5	Sanofi-Aventis Administrative Office	Santiago de Chile		Chile
6	Sanofi-Aventis Administrative Office	Santafe de Bogota		Colombia
7	Sanofi-Aventis Administrative Office	Praha		Czech Republic
8	Sanofi-Aventis Administrative Office	Helsinki		Finland
9	Sanofi-Aventis Administrative Office	Berlin		Germany
10	Sanofi-Aventis Administrative Office	Budapest		Hungary
11	Sanofi-Aventis Administrative Office	Mumbai		India
12	Sanofi-Aventis Administrative Office	Milan		Italy
13	Sanofi-Aventis Administrative Office	Mexico		Mexico
14	Sanofi-Aventis Administrative Office	Lysaker		Norway
15	Sanofi-Aventis Administrative Office	Lima		Peru
16	Sanofi-Aventis Administrative Office	Warszawa		Poland
17	Sanofi-Aventis Administrative Office	Moscow		Russian Federation
18	Sanofi-Aventis Administrative Office	Brastislava		Slovakia
19	Sanofi-Aventis Administrative Office	Madrid		Spain
20	Sanofi-Aventis Administrative Office	Istanbul		Turkey
21	Sanofi-Aventis Administrative Office	Guildford, Surrey		United Kingdom

Sponsors and Collaborators

Sanofi

Investigators

Study Director: ICD, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sanofi

ClinicalTrials.gov Identifier:

NCT00417209

Other Study ID Numbers:

EFC6596
EUDRACT: 2006-003086-14

First Posted:

Dec 29, 2006

Last Update Posted:

Jun 3, 2016

Last Verified:

May 1, 2016

Keywords provided by Sanofi

advanced pancreatic cancer

Additional relevant MeSH terms:

Pancreatic Neoplasms

Fluorouracil

Capecitabine

Study Results

No Results Posted as of Jun 3, 2016