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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Peking University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Xiansheng Pharmaceutical Co.Ltd.Jiangsu Province China
Information provided by:
Peking University
ClinicalTrials.gov Identifier:
NCT00842491
First received: February 11, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted

February 11, 2009
February 11, 2009
November 2008
April 2010   (final data collection date for primary outcome measure)
Progression free survival [ Time Frame: 3 year ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Tumor response rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Disease control rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  • adverse evens [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]
  • The alteration of relative regional blood volume of the tumor [ Time Frame: 3weeks ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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
Both
18 Years to 75 Years
No
Contact: xiaotian zhang, MD 86-10-88196561 zhangxtxx@gmail.com
Contact: fu chen, bachelor 86-10-88196561 kimandking@163.com
China
 
NCT00842491
ENDOCX
Yes
Shen lin, Peking University, School of Oncology, Department of GI oncology
Peking University
Xiansheng Pharmaceutical Co.Ltd.Jiangsu Province China
Principal Investigator: lin shen, MD Peking University, School of oncology, Department of GI oncology
Peking University
February 2009

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