A Study of Cetuximab(Erbitux) With Cisplatin and Capecitabine(Xeloda)as 1st Line Treatment in the Advanced Gastric Cancer

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Disease Information

Descriptive Information
Brief Title † A Study of Cetuximab(Erbitux) With Cisplatin and Capecitabine(Xeloda)as 1st Line Treatment in the Advanced Gastric Cancer
Official Title †
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 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.
Study Phase Phase 2
Study Type † Interventional
Study Design † Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † Tumor response rate
Secondary Outcome Measure † Time to progression Disease control rate Overall survival K-ras, b-raf, p53 gene mutation and EGFR gene copy number vs. tumor response safety
Condition † Gastric Cancer
Intervention † Drugcetuximab, cisplatin, capecitabine
Study Arms / Comparison Groups C225+Chemotherapy
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 41
Start Date † March 2007
Completion Date February 2009
Primary Completion Date December 2008
Eligibility Criteria † Inclusion Criteria: - Having signed informed consent - Age 18 to 75 years old - Histologically confirmed gastric adenocarcinoma - Unresectable recurrent or metastatic disease - Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 12 months - Measurable disease according to the RECIST criteria - Karnofsky performance status ≥60 - Life expectancy of ≥2 month - No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks - ALT and AST3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/dl Exclusion Criteria: - Brain metastasis (known or suspected) - Previous systemic therapy for metastatic gastric cancer - Inability to take oral medication - Previous EGFR pathway-targeting therapy - Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry - Heart failure, coronary artery disease, myocardial infarction within the last 6 months - Known allergy to any study treatment - Pregnancy or lactation period - Any investigational agent within the past 28 days - Other previous malignancy within 5 year, except non-melanoma skin cancer - Previous adjuvant therapy with capecitabine+platinum - Pre-existing neuropathy>grade 1 - Legal incapacity
Gender Both
Ages 18 Years - 75 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries † China
Administrative Information
NCT ID † NCT00477711
Organization ID EMR 62202-769
Secondary IDs ††
Responsible Party Principal Investigator
Study Sponsor † Peking University
Collaborators †† Merck Sharp & Dohme Corp.
Investigators † Principal Investigator: Lin Shen, MD, Peking University, School of oncology, Gastrointestinal Department
Information Provided By
Verification Date May 2015
First Received Date † May 22, 2007
Last Updated Date May 17, 2015
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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