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

Gastric Cancer Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

• NCT number: NCT00072787
• Study type: Interventional
• Source: Taiho Oncology, Inc.
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 2003
• Completion date: May 2006