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FOLFOX4 Combined With Endostar in Patients With Advanced Colorectal 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: NCT00813137
Recruitment Status : Unknown
Verified December 2009 by Simcere Pharmaceutical Co., Ltd.
Recruitment status was:  Recruiting
First Posted : December 22, 2008
Last Update Posted : December 8, 2009
The Affiliated Changzhou Tumor Hospital of Suzhou University
Information provided by:
Simcere Pharmaceutical Co., Ltd

Brief Summary:
FOLFOX4 plus Avastin has been suggested as firstline regimen for advanced colorectal cancer by NCCN, a new angiogenesis inhibitor, known as Endostar(Recombinant Human Endostatin), prolonged the overall survival, time to progression and improved response rate in metastatic lung cancer in a large phase III clinical trial in china, so we design this trial to evaluate the safty and efficacy of FolFox4 plus Endostar in patients with advanced colorectal cancer

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Drug: Folfox4 plus recombinant human endostatin (Endostar) Phase 2

Detailed Description:
Endostar is free supported by Shangdong Simcere Medgene biotech co.,Ltd. Endostar combination with Chemotherapy has been the first line treatment regimen to advanced NSCLC. Clinical data proved that Endostar was a wild spectrum and safe antiangiogenesis factor which could suppress almost 65 kinds of tumor mass in animal models and affect about 12 percent human genome. China NCCN colon or rectal cancer clinical practice guideline recommends Chemotherapy plus angiogenesis inhibitor as the first line treatment scheme. So we design FOLFOX4 plus Endostar to treat advanced colorectal cancer to research the RR and safety. We believe this treatment regimen may be a new approach to the advanced colorectal cancer patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center Study of Folfox4 Combined With Recombinant Human Endostatin(Endostar)in Advanced Colorectal Cancer
Study Start Date : October 2008
Estimated Primary Completion Date : October 2010
Estimated Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Folfox4 plus Endostar Drug: Folfox4 plus recombinant human endostatin (Endostar)
Endostar 15mg iv drip D1~7, D15~21, Oxaliplatin 85mg/m2 iv drip D1,15, CF 200mg/m2 iv drip D1,2,15,16, 5-Fu 400mg/m2 iv D1,2,15,16, 5-Fu 600mg/m2 civ D1,2,15,16
Other Names:
  • endostar
  • Folfox4
  • L-OHP
  • CF
  • 5-Fu

Primary Outcome Measures :
  1. Time to progression [ Time Frame: every two cycles ]

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:

  • Patients with histologically or cytologically confirmed metastatic CRC
  • Measurable disease according to Response Criteria In Solid Tumours (RECIST)
  • Performance Status 0 - 2 according to ECOG (Eastern Cooperative Oncology Group) Performance Status
  • Age 18~75
  • Life expectancy > 3 months
  • Signed informed consent (IC)
  • Adequate haematological and biological functions

Exclusion Criteria:

  • Pregnant or lactating women
  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drugs
  • Neuropathy, brain, or leptomeningeal involvement
  • Treatment with any biologic, cytotoxic, radiation , or hormonal therapy within four weeks.
  • Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia
  • Uncontrolled significant comorbid conditions and previous radiotherapy

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): NCT00813137

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Contact: Yang Ling, M.D. Ph.D.

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China, Jiangsu
The Affiliated Changzhou Tumor Hospital of Suzhou University Recruiting
Changzhou, Jiangsu, China, 213000
Contact: Joe, M.D.   
Principal Investigator: Yang Ling, M.D, Ph.D         
The Affiliated Zhongda Hospital of Southeast University Active, not recruiting
Nanjing, Jiangsu, China
Sponsors and Collaborators
Simcere Pharmaceutical Co., Ltd
The Affiliated Changzhou Tumor Hospital of Suzhou University
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Principal Investigator: Yang Ling, M.D, Ph.D The Affiliated Changzhou Tumor Hospital of Suzhou University
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Responsible Party: Yang Ling, the Affiliated Changzhou Tumor Hospital of Suzhou University Identifier: NCT00813137    
Other Study ID Numbers: simcere0803
First Posted: December 22, 2008    Key Record Dates
Last Update Posted: December 8, 2009
Last Verified: December 2009
Keywords provided by Simcere Pharmaceutical Co., Ltd:
Colorectal Cancer
recombinant human endostatin
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endostar protein
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents