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

Sponsor

Sanofi (Industry)

Overall Status

Terminated

CT.gov ID

NCT00602745

Collaborator

Taiho Pharmaceutical Co., Ltd. (Industry)

Enrollment

Locations

Arms

24.9

Duration (Months)

3.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Neoplasm Neoplasm Metastasis	Drug: S-1 Drug: 5-Fluorouracil	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Multicenter, Open-Label, Randomized Study Comparing Efficacy and Safety of S-1 as Single Agent Versus 5-FU Bolus for the Treatment of Patients With Metastatic Pancreatic Cancer Previously Treated With a Gemcitabine-Based Regimen

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 5-Fluorouracil	Drug: 5-Fluorouracil intravenous bolus
Experimental: S-1	Drug: S-1 oral administration

Arm

Intervention/Treatment

Active Comparator: 5-Fluorouracil

Drug: 5-Fluorouracil

intravenous bolus

Experimental: S-1

Drug: S-1

oral administration

Outcome Measures

Primary Outcome Measures

Overall Survival [study period]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey	United States	08807
2	Sanofi-Aventis Administrative Office	Vienna		Austria
3	Sanofi-Aventis Administrative Office	Sao Paulo		Brazil
4	Sanofi-Aventis Administrative Office	Laval		Canada
5	Sanofi-Aventis Administrative Office	San José		Costa Rica
6	Sanofi-Aventis Administrative Office	Horsholm		Denmark
7	Sanofi-Aventis Administrative Office	Paris		France
8	Sanofi-Aventis Administrative Office	Athens		Greece
9	Sanofi-Aventis Administrative Office	Mixco		Guatemala
10	Sanofi-Aventis Administrative Office	Budapest		Hungary
11	Sanofi-Aventis Administrative Office	Netanya		Israel
12	Sanofi-Aventis Administrative Office	Ocean Business Plaza		Panama
13	Sanofi-Aventis Administrative Office	Lima		Peru
14	Sanofi-Aventis Administrative Office	Bucuresti		Romania
15	Sanofi-Aventis Administrative Office	Midrand		South Africa
16	Sanofi-Aventis Administrative Office	Bromma		Sweden
17	Sanofi-Aventis Administrative Office	Megrine		Tunisia