Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00477711
Status:
COMPLETED
Last Update Posted:
2015-05-19
First Post:
2007-05-22
Brief Title:
A Study of CetuximabErbitux With Cisplatin and CapecitabineXelodaas 1st Line Treatment in the Advanced Gastric Cancer
Sponsor:
Peking University
Organization:
Peking University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXTRA
Brief Summary:
The purpose of this study is to investigate whether cetuximab Erbitux with cisplatin and capecitabine Xeloda as 1st line treatment in the advanced gastric cancer is effective
Detailed Description:
Gastric cancer remains one of the major causes of cancer deaths around the world especially in Asia Previous study of ML17032 has proved that XPcapecitabine plus cisplatinis effective in advanced gastric cancer with the overall response rate of 41 the median PFS of 56 month Recently the EGFR monoclonal antibody of cetuximab has shown to be successful in treating advanced colorectal cancer with or without chemotherapy Since EGFR also express in gastric cancer A single arm open multicenter phase II study of cetuximab in combination with cisplatin and capecitabine as first line treatment in patient with advanced gastric cancerIf applicable the value of mutations in k-ras b-raf P53 and EGFR copy number to predict the clinical response to cetuximab in advanced gastric cancer patients will also be accessedTumor tissue from study patients will be checked for k-ras b-raf and P53 mutation by sequencing and for EGFR copy number by chromogenic in situ hybridization DNA will be extracted from paraffin-embedded samples
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None