Continuous Infusion of FU Combined With Epirubicin and Oxaliplatin in Patients With A/MGC

Gastric Cancer Clinical Trial

Official title: Phase II Trial of Epirubicin, Oxaliplatin and 5-day 5-fluorouracil in Patients With Advanced and Metastatic Gastric Cancer

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and tolerability of the combination of epirubicin, oxaliplatin and 5-day continuous infusional 5-fluorouracil (EOF5 regimen) in patients with unresectable advanced or metastatic gastric cancer (A/MGC). Since Mar 2011, two addition second endpoints was added to the trial, one was to compare the consistence of two types of PET Scan evaluation with routine CT Scan evaluation, the other was to search for predictor factors of clinical results ( ORR,PFS and OS) with Pharmacogenomics methods. This modification was approved by the Ethic Committee of Fudan University Cancer Hospital, and the approval number was IRB50-15-1101A.

Clinical Trial Description

ECF regimen is considered as a reference regimen for gastric cancer in Europe. Now, no regimen has been proved to be more effective while less toxicity than ECF regimen. Oxaliplatin has demonstrated synergy with 5-FU in vitro, in vivo, and in the clinical setting in advanced colorectal cancer. It presents a better toxicity profile than cisplatin. Recently some studies used combination regimens of oxaliplatin, folinic acid, and continuous infusion 5-FU for about 44 hours (e.g FOLFOX4 ) to treat A/MGC, and yielded good response rates and median overall survival times while resulting in lower rates of grade 3-4 adverse events. Therefore, it is logical to modify ECF regimen with oxaliplatin replacing cisplatin and a short-term FU infusion replacing 21-day FU infusion. Our objective is to evaluate whether the EOF5 regimen is less toxicity while is comparable effective as ECF regimen. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

• NCT number: NCT00767377
• Study type: Interventional
• Source: Fudan University
• Status: Completed
• Phase: Phase 2
• Start date: May 2007
• Completion date: March 2013