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Pharmacokinetic and Pharmacodynamic Study of S-1 in Patients With Digestive Organ Cancer

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ClinicalTrials.gov Identifier: NCT00197431
Recruitment Status : Unknown
Verified December 2003 by Hamamatsu University.
Recruitment status was:  Recruiting
First Posted : September 20, 2005
Last Update Posted : March 22, 2006
Sponsor:
Information provided by:
Hamamatsu University

Study Description
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Brief Summary:
S-1 is a novel oral fluorouracil antitumor drug that consists of tegafur which is a prodrug of 5-fluorouracil (5-FU); 5-chloro-2,4-dihydropyridine (CDHP), which inhibits dihydropyrimidine dehydrogenase (DPD) activity; and potassium oxonate (Oxo), which reduces gastrointestinal toxicity. 5-FU is metabolized by CYP2A6 and DPD. In this study, the researchers investigate the influences of differences in activities of CYP2A6 and DPD on pharmacokinetics and pharmacodynamics of S-1 and clinical outcomes in digestive organ cancer patients treated with S-1.

Condition or disease Intervention/treatment Phase
Gastric Cancer Esophageal Cancer Pancreatic Cancer Colon Cancer Drug: S-1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic and Pharmacodynamic Study of S-1 and Its Effects in Patients With the Digestive Organ Cancer With Reference to Genetic Polymorphism and Activity of CYP2A6 and DPD
Study Start Date : January 2004

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Whether the differences in activities of CYP2A6 and DPD affect pharmacokinetics and pharmacodynamics of S-1 and clinical outcomes

Secondary Outcome Measures :
  1. Side effect and motility of patients treated with S-1

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Patients with digestive organ cancer

Exclusion Criteria:

  • Patients without digestive organ cancer
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00197431


Contacts
Contact: Naohito Shirai, MD., PhD 81-534-2788 naohito@hama-med.ac.jp

Locations
Japan
Hamamatsu University School of Medicine Recruiting
Hamamatsu, Shizuoka, Japan, 431-3192
Contact: Naohito Shirai, MD., PhD    81-534-2870    naohito@hama-med.ac.jp   
Principal Investigator: Takahisa Furuta, MD., PhD         
Sponsors and Collaborators
Hamamatsu University
Investigators
Study Chair: Naohito Shirai, MD., PhD Department Laboratory Medicine, Hamamatsu University School of Medicine
More Information
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ClinicalTrials.gov Identifier: NCT00197431     History of Changes
Other Study ID Numbers: S-12005
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 22, 2006
Last Verified: December 2003

Additional relevant MeSH terms:
Pancreatic Neoplasms
Stomach Neoplasms
Esophageal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
 Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases