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

NCT00417209 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2016-06-03

No results posted yet for this study

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.

Conditions

  • Pancreatic Neoplasms

Interventions

DRUG

Larotaxel (XRP9881)

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

DRUG

5-Fluorouracil

administered as IV infusion from Day 1 to Day 4

DRUG

Capecitabine

administered orally from Day 1 to Day 14 q3w

Sponsors & Collaborators

Principal Investigators

  • ICD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2009-07-31
Completion
2009-11-30

Countries

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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00417209 on ClinicalTrials.gov