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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00602745
Recruitment Status : Terminated (Following the termination of development and commercialization agreement for S-1 with Taiho Pharmaceutical)
First Posted : January 28, 2008
Last Update Posted : May 26, 2016
Taiho Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):

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

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Study Type : Interventional  (Clinical Trial)
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 : February 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 5-Fluorouracil Drug: 5-Fluorouracil
intravenous bolus

Experimental: S-1 Drug: S-1
oral administration

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: study period ]

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: every 6 weeks ]
  2. Overall Response Rate according to RECIST criteria [ Time Frame: every 6 weeks ]
  3. Clinical Benefit assessed by Time to Symptoms Worsening (TTSW) [ Time Frame: every 6 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00602745

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Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi Identifier: NCT00602745     History of Changes
Other Study ID Numbers: EFC10203
S-1 - FI
First Posted: January 28, 2008    Key Record Dates
Last Update Posted: May 26, 2016
Last Verified: April 2016
Keywords provided by Sanofi:
pancreatic cancer
Additional relevant MeSH terms:
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Neoplasm Metastasis
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Neoplastic Processes
Pathologic Processes
Digestive System Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs