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
- 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.
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
|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|