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

Sponsors and Collaborators:	Sanofi-Aventis Taiho Pharmaceutical Co., Ltd.
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00602745

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 III

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine hydrochloride Gemcitabine Fluorouracil S 1 (Combination)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Sanofi-Aventis:

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 ]

Estimated Enrollment:	400
Study Start Date:	December 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm A: Active Comparator	Drug: 5-Fluorouracil intravenous bolus
Arm B: Experimental	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-Aventis

Taiho Pharmaceutical Co., Ltd.

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( ICD study director )
Study ID Numbers:	EFC10203, S-1 - FI
Study First Received:	January 16, 2008
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00602745
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Israel: Ministry of Health

Keywords provided by Sanofi-Aventis:

pancreatic cancer

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Fluorouracil
Pancreatic Neoplasms
Neoplasm Metastasis
Endocrine System Diseases

Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antiviral Agents

Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 14, 2009