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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
  Purpose
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
Advanced Gastric Cancer Drug: endostar, cisplatin, capecitabine Drug: capecitabine Drug: cisplatin Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Shen Lin, Peking University:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 45
Study Start Date: November 2008
Study Completion Date: December 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00842491


Locations
China, Beijing
Department of GI Oncology, Peking University, School of Oncology
Beijing, Beijing, China, 100142
Sponsors and Collaborators
Peking University
Xiansheng Pharmaceutical Company
Investigators
Principal Investigator: lin shen, MD Peking University, School of oncology, Department of GI oncology
  More Information

Responsible Party: Shen Lin, pro., Peking University
ClinicalTrials.gov Identifier: NCT00842491     History of Changes
Other Study ID Numbers: ENDOCX
First Submitted: February 11, 2009
First Posted: February 12, 2009
Last Update Posted: May 19, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Cisplatin
Capecitabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action