Phase 1/2 Study of S-1 and Cisplatin in Advanced Gastric Cancer
- Conditions
- Gastric Cancer
- Registration Number
- NCT00072787
- Lead Sponsor
- Taiho Oncology, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
Lovelace Sandia Health System
🇺🇸Albuquerque, New Mexico, United States
University of New Mexico - Albuquerque
🇺🇸Albuquerque, New Mexico, United States
New Mexico VA Health Care System
🇺🇸Albuquerque, New Mexico, United States
University of Southern California Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Rosen, Lee
🇺🇸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
Abramson Cancer Center at the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States