FOLFOX4 Combined With Endostar in Patients With Advanced Colorectal Cancer - Full Text View

Sponsors and Collaborators:	Simcere Pharmaceutical Co., Ltd The Affiliated Changzhou Tumor Hospital of Suzhou University
Information provided by:	Simcere Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:	NCT00813137

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 II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center Study of Folfox4 Combined With Recombinant Human Endostatin(Endostar)in Advanced Colorectal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Fluorouracil Endostatin

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 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Folfox4 plus Endostar: Experimental	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

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:	the Affiliated Changzhou Tumor Hospital of Suzhou University ( Yang Ling )
Study ID Numbers:	simcere0803
Study First Received:	December 19, 2008
Last Updated:	December 21, 2008
ClinicalTrials.gov Identifier:	NCT00813137 History of Changes
Health Authority:	China: Ministry of Health

Keywords provided by Simcere Pharmaceutical Co., Ltd:

Colorectal Cancer
chemotherapy
recombinant human endostatin

Study placed in the following topic categories:

Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Endostatins
Intestinal Diseases
Rectal Diseases
Angiogenesis Inhibitors

Intestinal Neoplasms
Oxaliplatin
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Digestive System Neoplasms
Gastrointestinal Diseases
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Colonic Diseases
Endostatins
Intestinal Diseases
Angiogenesis Inhibitors
Rectal Diseases

Pharmacologic Actions
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Growth Inhibitors
Angiogenesis Modulating Agents
Colorectal Neoplasms

ClinicalTrials.gov processed this record on August 28, 2009