Gastric cancer remains one of the major causes of cancer deaths around the world, especially
in Asia. Previous study of ML17032 has proved that XP(capecitabine plus cisplatin)is
effective in advanced gastric cancer, with the overall response rate of 41%, the median PFS
of 5.6 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 cancer.If 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 accessed.Tumor 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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor response rate
1 year
No
Lin Shen, MD
Principal Investigator
Peking University, School of oncology, Gastrointestinal Department
China: Food and Drug Administration
EMR 62202-769
NCT00477711
March 2007
February 2009
Name | Location |
---|