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

Study Overview

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.

N/A

Pancreatic Neoplasms

DRUG: Larotaxel (XRP9881)
DRUG: 5-Fluorouracil
DRUG: Capecitabine

EFC6596
EUDRACT: 2006-003086-14

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2006-12-28	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-05-03
First Submitted that Met QC Criteria 2006-12-28	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-06-03
First Posted (ESTIMATED) 2006-12-29	Results First Posted N/A	Last Verified 2016-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Larotaxel (XRP9881)	DRUG: Larotaxel (XRP9881) administered as a 1-hour IV infusion on Day 1 of every 3 weeks (q3w)
ACTIVE_COMPARATOR: 5-Fluorouracil or capecitabine 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-Fluorouracil administered as IV infusion from Day 1 to Day 4 DRUG: Capecitabine administered orally from Day 1 to Day 14 q3w

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Larotaxel (XRP9881)

DRUG: Larotaxel (XRP9881)

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

ACTIVE_COMPARATOR: 5-Fluorouracil or capecitabine

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-Fluorouracil

administered as IV infusion from Day 1 to Day 4

DRUG: Capecitabine

administered orally from Day 1 to Day 14 q3w

Primary Outcome Measures	Measure Description	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 Outcome Measures	Measure Description	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: ICD, Sanofi

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record