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

Sanofi408 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

408

Conditions

Pancreatic Neoplasms

Interventions

Larotaxel (XRP9881)DRUG

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

5-FluorouracilDRUG

administered as IV infusion from Day 1 to Day 4

CapecitabineDRUG

administered orally from Day 1 to Day 14 q3w

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (21)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Sanofi-Aventis Administrative Office

Diegem, Belgium

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.