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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00842491
First Posted: February 12, 2009
Last Update Posted: May 19, 2015
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.
Collaborator:
Xiansheng Pharmaceutical Company
Information provided by (Responsible Party):
Shen Lin, Peking University
February 11, 2009
February 12, 2009
May 19, 2015
November 2008
April 2010   (Final data collection date for primary outcome measure)
Progression free survival [ Time Frame: 3 year ]
Same as current
Complete list of historical versions of study NCT00842491 on ClinicalTrials.gov Archive Site
  • Tumor response rate [ Time Frame: 1 year ]
  • Disease control rate [ Time Frame: 1 year ]
  • Overall survival [ Time Frame: 5 year ]
  • adverse evens [ Time Frame: 5 year ]
  • The alteration of relative regional blood volume of the tumor [ Time Frame: 3weeks ]
Same as current
Not Provided
Not Provided
 
Study of Endostar With Cisplatin and Capecitabine as 1st Line Treatment in the Advanced Gastric Cancer
A Phase II Study of Endostar (Recombinant Human Endostatin ®) With Cisplatin and Capecitabine (Xeloda) as 1st Line Treatment in the Advanced Gastric Cancer
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.
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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Gastric Cancer
  • 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

Experimental: endostar+chemotherapy
Interventions:
  • Drug: endostar, cisplatin, capecitabine
  • Drug: capecitabine
  • Drug: cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
December 2010
April 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00842491
ENDOCX
Yes
Not Provided
Not Provided
Shen Lin, Peking University
Peking University
Xiansheng Pharmaceutical Company
Principal Investigator: lin shen, MD Peking University, School of oncology, Department of GI oncology
Peking University
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP