Pharmacokinetic and Pharmacodynamic Study of S-1 in Patients With Digestive Organ Cancer
Conditions
Gastric Cancer - Esophageal Cancer - Pancreatic Cancer - Colon Cancer
Conditions: official terms
Esophageal Neoplasms - Pancreatic Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: S-1
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers:
Maximum Age: 85 Years
Minimum Age: 20 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patients with digestive organ cancer

Exclusion Criteria:

- Patients without digestive organ cancer
Location
Hamamatsu University School of Medicine
Hamamatsu, Shizuoka, Japan
Status: Recruiting
Contact: Naohito Shirai, MD., PhD - 81-534-2870 - naohito@hama-med.ac.jp
Start Date
January 2004
Sponsors
Hamamatsu University
Source
Hamamatsu University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page