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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
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Peking University:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 3 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 45
Study Start Date: November 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00842491

Contacts
Contact: xiaotian zhang, MD 86-10-88196561 zhangxtxx@gmail.com
Contact: fu chen, bachelor 86-10-88196561 kimandking@163.com

Locations
China, Beijing
Department of GI Oncology, Peking University, School of Oncology Recruiting
Beijing, Beijing, China, 100142
Contact: Xiaotian zhang, MD    86-10-88196561    zhangxtxx@gmail.com   
Sponsors and Collaborators
Peking University
Xiansheng Pharmaceutical Co.Ltd.Jiangsu Province China
Investigators
Principal Investigator: lin shen, MD Peking University, School of oncology, Department of GI oncology
  More Information

No publications provided

Responsible Party: Shen lin, Peking University, School of Oncology, Department of GI oncology
ClinicalTrials.gov Identifier: NCT00842491     History of Changes
Other Study ID Numbers: ENDOCX
Study First Received: February 11, 2009
Last Updated: February 11, 2009
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Stomach Diseases
Capecitabine
Cisplatin
Fluorouracil
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014