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

This study has been terminated.
(Following the termination of development and commercialization agreement for S-1 with Taiho Pharmaceutical)
Sponsor:
Collaborator:
Taiho Pharmaceutical Co., Ltd.
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00602745
First received: January 16, 2008
Last updated: December 16, 2010
Last verified: December 2010
History of Changes
  Purpose

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 Intervention Phase
Pancreatic Neoplasm
Neoplasm Metastasis
 Drug: S-1
Drug: 5-Fluorouracil
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]
  • Overall Response Rate according to RECIST criteria [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]
  • Clinical Benefit assessed by Time to Symptoms Worsening (TTSW) [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: February 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A Drug: 5-Fluorouracil
intravenous bolus
Experimental: Arm B Drug: S-1
oral administration

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602745

  Show 17 Study Locations
Sponsors and Collaborators
Sanofi
Taiho Pharmaceutical Co., Ltd.
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00602745     History of Changes
Other Study ID Numbers: EFC10203, S-1 - FI
Study First Received: January 16, 2008
Last Updated: December 16, 2010
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Israel: Ministry of Health

Keywords provided by Sanofi:
pancreatic cancer

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Pancreatic Neoplasms
Neoplastic Processes
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Fluorouracil
Gemcitabine
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 16, 2013