FOLFOX4 Combined With Endostar in Patients With Advanced Colorectal Cancer

Phase 2

• Conditions: Colorectal Neoplasms
• Interventions: Drug: Folfox4 plus recombinant human endostatin (Endostar)

• Registration Number: NCT00813137
• Lead Sponsor: 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

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-12-19
• Study First Submitted QC: 2008-12-19
• Study First Posted: 2008-12-22
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-06
• Last Update Posted: 2009-12-08
• Primary Completion: 2010-10
• Study Completion: 2010-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Folfox4 plus Endostar	Folfox4 plus recombinant human endostatin (Endostar)	-

Primary Outcome Measures

Name	Time	Method
Time to progression	every two cycles

Trial Locations

Locations (2)

The Affiliated Zhongda Hospital of Southeast University; 🇨🇳 Nanjing, Jiangsu, China

The Affiliated Changzhou Tumor Hospital of Suzhou University; 🇨🇳 Changzhou, Jiangsu, China