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

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

This study is currently recruiting participants.
Verified by Hamamatsu University, December 2003

Sponsored by:	Hamamatsu University
Information provided by:	Hamamatsu University
ClinicalTrials.gov Identifier:	NCT00197431

Purpose

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	Intervention	Phase
Gastric Cancer Esophageal Cancer Pancreatic Cancer Colon Cancer	Drug: S-1	Phase II

MedlinePlus related topics:

Cancer Esophageal Cancer Esophagus Disorders Pancreatic Cancer Stomach Cancer

ChemIDplus related topics:

S 1 (Combination)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study

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

Further study details as provided by Hamamatsu University:

Primary Outcome Measures:

Whether the differences in activities of CYP2A6 and DPD affect pharmacokinetics and pharmacodynamics of S-1 and clinical outcomes

Secondary Outcome Measures:

Side effect and motility of patients treated with S-1

Study Start Date:

January 2004

Eligibility

Ages Eligible for Study:	20 Years to 85 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Patients with digestive organ cancer

Exclusion Criteria:

Patients without digestive organ cancer

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00197431

Contacts


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

Locations


Japan, Shizuoka
	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

Study ID Numbers:	S-12005
First Received:	September 12, 2005
Last Updated:	March 21, 2006
ClinicalTrials.gov Identifier:	NCT00197431
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Digestive System Neoplasms

Esophageal disorder

Gastrointestinal Diseases

Esophageal Neoplasms

Pancreatic Neoplasms

Colonic Diseases

Endocrine System Diseases

Stomach cancer

Intestinal Diseases

Intestinal Neoplasms

Stomach Diseases

Digestive System Diseases

Head and Neck Neoplasms

Stomach Neoplasms

Pancreatic Diseases

Gastrointestinal Neoplasms

Endocrinopathy

Esophageal Diseases

Esophageal neoplasm

Colonic Neoplasms

Colorectal Neoplasms

Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on September 23, 2008