Spots Global Cancer Trial Database for Phase 1/2 Study of S-1 and Cisplatin in Advanced Gastric Cancer
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Trial Identification
Brief Title: Phase 1/2 Study of S-1 and Cisplatin in Advanced Gastric Cancer
Official Title: 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
Study ID: NCT00072787
Conditions
Study Description
Brief Summary: The purpose of the phase 1 portion of the study is to determine the safe dose of S-1 and cisplatin that can be administered in gastric cancer patients. The purpose of the phase 2 portion of the study is to determine the antitumor activity of the S-1 and cisplatin regimen established from phase 1 in patients with advanced gastric cancer.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Rosen, Lee, Los Angeles, California, United States
University of Southern California Norris Comprehensive Cancer Center, Los Angeles, California, United States
Chong, Clayton, Honolulu, Hawaii, United States
Straub Clinic and Hospital, Honolulu, Hawaii, United States
Northwestern University Robert H Lurie Comprehensive Cancer Center, Chicago, Illinois, United States
University of Chicago, Chicago, Illinois, United States
Lovelace Sandia Health System, Albuquerque, New Mexico, United States
New Mexico VA Health Care System, Albuquerque, New Mexico, United States
University of New Mexico - Albuquerque, Albuquerque, New Mexico, United States
Abramson Cancer Center at the University of Pennsylvania, Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center, Houston, Texas, United States
Contact Details
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