A Phase II Study of Endostar (Recombinant Human Endostatin ®) With Cisplatin and Capecitabine (Xeloda) as 1st Line Treatment in the Advanced Gastric Cancer

Peking University1 site in 1 country45 target enrollmentNovember 2008

ConditionsAdvanced Gastric Cancer

Interventionsendostar, cisplatin, capecitabine capecitabine cisplatin

Drugsendostar, cisplatin, capecitabine capecitabine cisplatin

Overview

Phase: Phase 2
Intervention: endostar, cisplatin, capecitabine
Conditions: Advanced Gastric Cancer
Sponsor: Peking University
Enrollment: 45
Locations: 1
Primary Endpoint: Progression free survival
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

November 2008

End Date

December 2010

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Peking University

Responsible Party

Principal Investigator

Shen Lin

pro.

Peking University

Eligibility Criteria

Inclusion Criteria

•Having signed informed consent
•Age 18 to 70 years old
•Histologically confirmed gastric adenocarcinoma
•Unresectable recurrent or metastatic disease
•Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months
•Previous chemotherapy with capecitabine or cisplatin, 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

Exclusion Criteria

•Brain metastasis (known or suspected)
•Previous systemic therapy for metastatic gastric cancer
•Inability to take oral medication
•Previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy
•Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry
•Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on.
•Allergic constitution or allergic history to protium biologic product or any investigating agents.
•Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.
•Pregnancy or lactation period
•Any investigational agent within the past 28 days