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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00417209

Acronym

PAPRIKA

Enrollment

408

Registered

2006-12-29

Start date

2006-12-31

Completion date

2009-11-30

Last updated

2016-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Neoplasms

Keywords

advanced pancreatic cancer

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.

Interventions

DRUGLarotaxel (XRP9881)

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

DRUG5-Fluorouracil

administered as IV infusion from Day 1 to Day 4

DRUGCapecitabine

administered orally from Day 1 to Day 14 q3w

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Belgium, Brazil, Canada, Chile, Colombia, Czechia, Finland, Germany, Hungary, India, Italy, Mexico, Norway, Peru, Poland, Russia, Slovakia, Spain, Turkey (Türkiye), United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026