FOLFOX4 Combined With Endostar in Patients With Advanced Colorectal Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Drug: Folfox4 plus recombinant human endostatin (Endostar)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Folfox4 plus Endostar<br> | Drug: Folfox4 plus recombinant human endostatin (Endostar)<br>* 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<br>* Other names: 5-Fu;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  | every two cycles | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Cancer, chemotherapy, recombinant human endostatin