Status:
UNKNOWN
FOLFOX4 Combined With Endostar in Patients With Advanced Colorectal Cancer
Lead Sponsor:
Simcere Pharmaceutical Co., Ltd
Collaborating Sponsors:
The Affiliated Changzhou Tumor Hospital of Suzhou University
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 overal...
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 E...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2010
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00813137
Start Date
October 1 2008
End Date
October 1 2010
Last Update
December 8 2009
Active Locations (2)
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1
The Affiliated Changzhou Tumor Hospital of Suzhou University
Changzhou, Jiangsu, China, 213000
2
The Affiliated Zhongda Hospital of Southeast University
Nanjing, Jiangsu, China