S-1 Versus 5-FU Bolus In Metastatic Pancreatic Cancer Patients Previously Treated With Gemcitabine-Based Regimen

Study Overview

S-1 Versus 5-FU Bolus in Metastatic Pancreatic Cancer Patients Previously Treated With Gemcitabine-Based Regimen

The primary objective of this study is to determine whether S-1 increases overall survival when compared to 5-Fluorouracil (5-FU) in patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy. The secondary objectives are to compare: progression free survival, overall response rate, clinical benefit and improvement in tumor related symptoms and also to assess overall safety and pharmacokinetics of S-1.

N/A

Pancreatic Neoplasm
Neoplasm Metastasis

DRUG: S-1
DRUG: 5-Fluorouracil

EFC10203
S-1 - FI

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 2008-01-16	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-04-27
First Submitted that Met QC Criteria 2008-01-16	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-05-26
First Posted (ESTIMATED) 2008-01-28	Results First Posted N/A	Last Verified 2016-04

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
ACTIVE_COMPARATOR: 5-Fluorouracil	DRUG: 5-Fluorouracil intravenous bolus
EXPERIMENTAL: S-1	DRUG: S-1 oral administration

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: 5-Fluorouracil

DRUG: 5-Fluorouracil

intravenous bolus

EXPERIMENTAL: S-1

DRUG: S-1

oral administration

Primary Outcome Measures	Measure Description	Time Frame
Overall Survival		study period

Secondary Outcome Measures	Measure Description	Time Frame
Progression Free Survival		every 6 weeks
Overall Response Rate according to RECIST criteria		every 6 weeks
Clinical Benefit assessed by Time to Symptoms Worsening (TTSW)		every 6 weeks

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:

Cytologically or histologically confirmed evidence of adenocarcinoma of the exocrine pancreas
Metastatic disease previously treated with a gemcitabine-based regimen

Locally advanced disease
More than one prior chemotherapy-line for advanced pancreatic disease
Prior treatment with fluoropyrimidines for advanced pancreatic cancer
Eastern Cooperative Oncology Group (ECOG) performance status >or= 2
Poor kidney, liver or bone marrow functions
Any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study
Unable to swallow capsules
Hypersensitivity history to any of the constituents of the study medications or fluoropyrimidines
Concurrent participation in another clinical trial or treatment with any other anticancer therapy

Collaborators and Investigators

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

Taiho Pharmaceutical Co., Ltd.

Investigators

STUDY_DIRECTOR: Clinical Sciences & Operations, 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