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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified December 2003 by Hamamatsu University.
Recruitment status was: Recruiting

Sponsor:

Information provided by:

Hamamatsu University

ClinicalTrials.gov Identifier:

NCT00197431

First received: September 12, 2005

Last updated: March 21, 2006

Last verified: December 2003

History of Changes

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 2


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Stomach Cancer Esophageal Cancer

U.S. FDA Resources

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 (Adult, Senior)
Sexes Eligible for Study:	All

Criteria

Inclusion Criteria:

Patients with digestive organ cancer

Exclusion Criteria:

Patients without digestive organ cancer

Contacts and Locations

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, see Learn About Clinical Studies.

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
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


ClinicalTrials.gov Identifier:	NCT00197431 History of Changes
Other Study ID Numbers:	S-12005
Study First Received:	September 12, 2005
Last Updated:	March 21, 2006

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

ClinicalTrials.gov processed this record on September 21, 2017

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