A Phase I/II, Open-Label, Nonrandomized, Dose-Finding Safety, Tolerance, Pharmacokinetic, and Efficacy Study of Orally Administered S-1 in Combination With Cisplatin in Patients With Advanced Gastric Cancer
S-1 is an oral fluoropyrimidine which combines tegafur (a 5-FU prodrug) with two classes of
modulators which:
- inhibit dihydropyrimidine dehydrogenase (DPD) and
- block phosphorylation of 5-FU in gastrointestinal tissues.
S-1 is designed to enhance the the clinical utility of an oral fluoropyrimidine while
ameliorating the disadvantage of gastrointestinal toxicity.
5-Fu and cisplatin have been used as a standard treatment in gastric cancer and preliminary
data indicate that S-1 plus cisplatin may result in superior tolerability and efficacy in
advanced gastric cancer.
S-1 is currently approved in Japan for treatment of gastric cancer and head and neck cancer.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
TPU-S1101; ID02-694
NCT00072787
October 2003
May 2006
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
Abramson Cancer Center at the University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
Straub Clinic and Hospital | Honolulu, Hawaii 96813 |
University of Chicago | Chicago, Illinois 60637 |
University of Southern California Norris Comprehensive Cancer Center | Los Angeles, California 90089 |
Rosen, Lee | Los Angeles, California 90025 |
Chong, Clayton | Honolulu, Hawaii 96817 |
Northwestern University Robert H Lurie Comprehensive Cancer Center | Chicago, Illinois 60611 |
Lovelace Sandia Health System | Albuquerque, New Mexico 87108 |
University of New Mexico - Albuquerque | Albuquerque, New Mexico 87131 |
New Mexico VA Health Care System | Albuquerque, New Mexico 87108 |