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Sponsors and Collaborators: |
Peking University Merck |
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Information provided by: | Peking University |
ClinicalTrials.gov Identifier: | NCT00477711 |
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.
Condition | Intervention | Phase |
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Gastric Cancer |
Drug: cetuximab, cisplatin, capecitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 41 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
China | |
Peking University,School of Oncology, Gastrointestinal Department | |
Beijing, China, 100036 |
Principal Investigator: | Lin Shen, MD | Peking University, School of oncology, Gastrointestinal Department |
Responsible Party: | Peking University, School of Oncology, Department of GI oncology ( Xiaotian Zhang ) |
Study ID Numbers: | EMR 62202-769 |
Study First Received: | May 22, 2007 |
Last Updated: | November 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00477711 |
Health Authority: | China: State Food and Drug Administration |
Cetuximab cisplatin capecitabine first line treatment |
Capecitabine Stomach Diseases Digestive System Diseases Digestive System Neoplasms Cisplatin |
Gastrointestinal Diseases Stomach Neoplasms Cetuximab Gastrointestinal Neoplasms Stomach cancer |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Molecular Mechanisms of Pharmacological Action |
Radiation-Sensitizing Agents Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Pharmacologic Actions |