FOLFOX4 Combined With Endostar in Patients With Advanced Colorectal Cancer

Colorectal Neoplasms Clinical Trial

Official title:

A Multi-center Study of Folfox4 Combined With Recombinant Human Endostatin(Endostar)in Advanced Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00813137
• Other study ID #: simcere0803
• Status: Recruiting
• Phase: Phase 2
• First received: December 19, 2008
• Last updated: December 6, 2009
• Start date: October 2008
• Est. completion date: October 2010

Study information

• Verified date: December 2009
• Source: Simcere Pharmaceutical Co., Ltd
• Contact: Yang Ling, M.D. Ph.D.
• Email: medilyn2001[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	The Affiliated Changzhou Tumor Hospital of Suzhou University	Changzhou	Jiangsu
China	The Affiliated Zhongda Hospital of Southeast University	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Simcere Pharmaceutical Co., Ltd	The Affiliated Changzhou Tumor Hospital of Suzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression		every two cycles	Yes