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

Neoplasm Metastasis Clinical Trial

— S-1 Pancreas  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00602745
• Other study ID #: EFC10203
• Secondary ID: S-1 - FI
• Status: Terminated
• Phase: Phase 3
• First received: January 16, 2008
• Last updated: December 16, 2010
• Start date: February 2008
• Est. completion date: March 2010

Study information

• Verified date: December 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 61
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

• 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 fluoropyrimides

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Neoplasms
• Pancreatic Neoplasm
• Pancreatic Neoplasms

Intervention

Drug:
• S-1
oral administration
• 5-Fluorouracil
intravenous bolus

Locations

Country	Name	City	State
Austria	Sanofi-Aventis Administrative Office	Vienna
Brazil	Sanofi-Aventis Administrative Office	Sao Paulo
Canada	Sanofi-Aventis Administrative Office	Laval
Costa Rica	Sanofi-Aventis Administrative Office	San José
Denmark	Sanofi-Aventis Administrative Office	Horsholm
France	Sanofi-Aventis Administrative Office	Paris
Greece	Sanofi-Aventis Administrative Office	Athens
Guatemala	Sanofi-Aventis Administrative Office	Mixco
Hungary	Sanofi-Aventis Administrative Office	Budapest
Israel	Sanofi-Aventis Administrative Office	Netanya
Panama	Sanofi-Aventis Administrative Office	Ocean Business Plaza
Peru	Sanofi-Aventis Administrative Office	Lima
Romania	Sanofi-Aventis Administrative Office	Bucuresti
South Africa	Sanofi-Aventis Administrative Office	Midrand
Sweden	Sanofi-Aventis Administrative Office	Bromma
Tunisia	Sanofi-Aventis Administrative Office	Megrine
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Taiho Pharmaceutical Co., Ltd.

Countries where clinical trial is conducted

United States,  Austria,  Brazil,  Canada,  Costa Rica,  Denmark,  France,  Greece,  Guatemala,  Hungary,  Israel,  Panama,  Peru,  Romania,  South Africa,  Sweden,  Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		study period	No
Secondary	Progression Free Survival		every 6 weeks	No
Secondary	Overall Response Rate according to RECIST criteria		every 6 weeks	No
Secondary	Clinical Benefit assessed by Time to Symptoms Worsening (TTSW)		every 6 weeks	No