NCT00417209|CompletedPhase 3DMC

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

PAPRIKA

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

Sanofi ClinicalTrials.gov

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2 other identifiers

EFC6596EUDRACT: 2006-003086-14

Study Type

interventional

Target

408

Locations

21 countries

Sites

Timeline

RegisteredDec 2006

StartedDec 2006

CompletionNov 2009

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

408

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Dec 2006

Typical duration for phase_3

Geographic Reach

21 countries

21 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.9 years study duration

Study Start

First participant enrolled

December 1, 2006

Completed

27 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 29, 2006

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed

Last Updated

June 3, 2016

Status Verified

May 1, 2016

Enrollment Period

2.6 years

First QC Date

December 28, 2006

Last Update Submit

May 3, 2016

Conditions

Pancreatic Neoplasms

Keywords

advanced pancreatic cancer

Outcome Measures

Primary Outcomes (1)

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 Outcomes (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;
study period

Study Arms (2)

Larotaxel (XRP9881)

EXPERIMENTAL

Drug: Larotaxel (XRP9881)

5-Fluorouracil or capecitabine

ACTIVE COMPARATOR

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-FluorouracilDrug: Capecitabine

Interventions

Larotaxel (XRP9881)DRUG

administered as a 1-hour IV infusion on Day 1 of every 3 weeks (q3w)

Larotaxel (XRP9881)

5-FluorouracilDRUG

administered as IV infusion from Day 1 to Day 4

5-Fluorouracil or capecitabine

CapecitabineDRUG

administered orally from Day 1 to Day 14 q3w

5-Fluorouracil or capecitabine

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.