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OpenTrials
Completed

NCT Number: NCT00417209

Larotaxel Compared To Continuous Administration of 5-FU in Advanced Pancreatic Cancer Patients 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.

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Key information

Conditions

Pancreatic Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Administrative Office, Diegem, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Larotaxel (XRP9881)

Drug

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

5-fluorouracil

Drug

administered as IV infusion from Day 1 to Day 4

Capecitabine

Drug

administered orally from Day 1 to Day 14 q3w

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

    Time frame: 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;

    Time frame: study period

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: PAPRIKA

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Dec 29, 2006
Registry last updated
Jun 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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