NCT00072787

Phase 1/2 Study of S-1 and Cisplatin in Advanced Gastric Cancer

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 41 (planned)
• Sponsor: Taiho Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	S-1
DRUG	cisplatin

Timeline

• Start date: 2003-10-01
• Primary completion: 2006-03-01
• Completion: 2006-05-01
• First posted: 2003-11-13
• Last updated: 2024-09-03

Locations

11 sites across 1 country: United States