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Study of Endostar With Cisplatin and Capecitabine as 1st Line Treatment in the Advanced Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00842491
Recruitment Status : Completed
First Posted : February 12, 2009
Last Update Posted : May 19, 2015
Xiansheng Pharmaceutical Company
Information provided by (Responsible Party):
Shen Lin, Peking University

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.

Condition or disease Intervention/treatment Phase
Advanced Gastric Cancer Drug: endostar, cisplatin, capecitabine Drug: capecitabine Drug: cisplatin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: endostar+chemotherapy Drug: endostar, cisplatin, capecitabine

Product 1: endostar

Dosing schedule: 15mg daily dose, d1-14

Mode of administration: intravenously

Drug: capecitabine

Product 2: capecitabine

Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks

Mode of administration: orally

Drug: cisplatin

Product 3: cisplatin

Dosing schedule: 80mg/m2, day 1 of every 3 weeks

Mode of administration: intravenously

Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 3 year ]

Secondary Outcome Measures :
  1. Tumor response rate [ Time Frame: 1 year ]
  2. Disease control rate [ Time Frame: 1 year ]
  3. Overall survival [ Time Frame: 5 year ]
  4. adverse evens [ Time Frame: 5 year ]
  5. The alteration of relative regional blood volume of the tumor [ Time Frame: 3weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  • ALT and AST<2.5 times ULN (≤5 times ULN in patients with liver metastases)
  • Serum albumin level ≥3.0g/dL
  • Serum AKP < 2.5 times ULN
  • Serum creatinine <ULN, and CCr < 60ml/min
  • Bilirubin level < 1.5 ULN
  • WBC>3,000/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 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
  • Other previous malignancy within 5 year, except non-melanoma skin cancer
  • Previous adjuvant therapy with capecitabine+platinum,
  • Pre-existing neuropathy>grade 1
  • Legal incapacity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00842491

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China, Beijing
Department of GI Oncology, Peking University, School of Oncology
Beijing, Beijing, China, 100142
Sponsors and Collaborators
Peking University
Xiansheng Pharmaceutical Company
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Principal Investigator: lin shen, MD Peking University, School of oncology, Department of GI oncology
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Responsible Party: Shen Lin, pro., Peking University Identifier: NCT00842491    
Other Study ID Numbers: ENDOCX
First Posted: February 12, 2009    Key Record Dates
Last Update Posted: May 19, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Endostar protein
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors