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FOLFOX4 Combined With Endostar in Patients With Advanced Colorectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Simcere Pharmaceutical Co., Ltd.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
The Affiliated Changzhou Tumor Hospital of Suzhou University
Information provided by:
Simcere Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT00813137
First received: December 19, 2008
Last updated: December 6, 2009
Last verified: December 2009
History of Changes
  Purpose

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 Intervention Phase
Colorectal Neoplasms
 Drug: Folfox4 plus recombinant human endostatin (Endostar)
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-center Study of Folfox4 Combined With Recombinant Human Endostatin(Endostar)in Advanced Colorectal Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Simcere Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • Time to progression [ Time Frame: every two cycles ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: October 2008
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00813137

Contacts
Contact: Yang Ling, M.D. Ph.D. medilyn2001@yahoo.com.cn

Locations
China, Jiangsu
The Affiliated Changzhou Tumor Hospital of Suzhou University Recruiting
Changzhou, Jiangsu, China, 213000
Contact: Joe, M.D.         joeton@21cn.com    
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
Investigators
Principal Investigator: Yang Ling, M.D, Ph.D The Affiliated Changzhou Tumor Hospital of Suzhou University
  More Information

No publications provided

Responsible Party: Yang Ling, the Affiliated Changzhou Tumor Hospital of Suzhou University
ClinicalTrials.gov Identifier: NCT00813137     History of Changes
Other Study ID Numbers: simcere0803
Study First Received: December 19, 2008
Last Updated: December 6, 2009
Health Authority: China: Ministry of Health

Keywords provided by Simcere Pharmaceutical Co., Ltd:
Colorectal Cancer
chemotherapy
recombinant human endostatin

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
 Rectal Diseases
Endostatins
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013