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Sponsors and Collaborators: |
Peking University Xiansheng Pharmaceutical Co.Ltd.Jiangsu Province China |
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Information provided by: | Peking University |
ClinicalTrials.gov Identifier: | NCT00842491 |
The purpose of this study is to investigate whether endostar (recombinant human endostatin)with cisplatin and capecitabine (Xeloda) as 1st line treatment in the advanced gastric cancer is effective and safe.
Condition | Intervention | Phase |
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Advanced Gastric Cancer |
Drug: endostar, cisplatin, capecitabine Drug: capecitabine Drug: cisplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Efficacy Study, Open Label, Single Group Assignment, Treatment, Uncontrolled |
Official Title: | A Phase II Study of Endostar (Recombinant Human Endostatin ®) With Cisplatin and Capecitabine (Xeloda) as 1st Line Treatment in the Advanced Gastric Cancer |
Estimated Enrollment: | 45 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Product 1: endostar
Dosing schedule: 15mg daily dose, d1-14
Mode of administration: intravenously
Product 2: capecitabine
Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks
Mode of administration: orally
Product 3: cisplatin
Dosing schedule: 80mg/m2, day 1 of every 3 weeks
Mode of administration: intravenously
Endostar, a recombinant human endostatin, has shown its antitumor ability in combination in NSCLC and breast cancer. But to gastric cancer, few clinical data has been reported. However, bevacizumab, an angiogenesis inhibitor was shown effective in combination with chemotherapy in advanced gastric cancer in some phase II study. So in this study, we want to explore whether endostar is also effective and safe in advanced gastric cancer. Response predictive factor is expected to be identified.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: xiaotian zhang, MD | 86-10-88196561 | zhangxtxx@gmail.com |
Contact: fu chen, bachelor | 86-10-88196561 | kimandking@163.com |
China | |
Department of GI Oncology, Peking University, School of Oncology | Recruiting |
Beijing, China, 100142 | |
Contact: Xiaotian zhang, MD 86-10-88196561 zhangxtxx@gmail.com |
Principal Investigator: | lin shen, MD | Peking University, School of oncology, Department of GI oncology |
Responsible Party: | Peking University, School of Oncology, Department of GI oncology ( Shen lin ) |
Study ID Numbers: | ENDOCX |
Study First Received: | February 11, 2009 |
Last Updated: | February 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00842491 History of Changes |
Health Authority: | China: State Food and Drug Administration |
Antimetabolites Capecitabine Stomach Diseases Digestive System Diseases Digestive System Neoplasms Radiation-Sensitizing Agents |
Cisplatin Gastrointestinal Diseases Stomach Neoplasms Gastrointestinal Neoplasms Endostatins Stomach Cancer |
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Physiological Effects of Drugs Pharmacologic Actions |
Neoplasms Neoplasms by Site Digestive System Diseases Stomach Diseases Radiation-Sensitizing Agents Cisplatin Stomach Neoplasms Therapeutic Uses Gastrointestinal Neoplasms |