A Multi-center Study of Folfox4 Combined With Recombinant Human Endostatin(Endostar)in Advanced Colorectal Cancer
18 Years
75 Years
Both
Colorectal Neoplasms
Trial Information
A Multi-center Study of Folfox4 Combined With Recombinant Human Endostatin(Endostar)in Advanced Colorectal Cancer
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to progression
Outcome Time Frame:
every two cycles
Safety Issue:
Yes
Principal Investigator
Yang Ling, M.D, Ph.D
Investigator Role:
Principal Investigator
Investigator Affiliation:
The Affiliated Changzhou Tumor Hospital of Suzhou University
Authority:
China: Ministry of Health
Study ID:
simcere0803
NCT ID:
NCT00813137
Start Date:
October 2008
Completion Date:
October 2010
Related Keywords:
- Colorectal Neoplasms
- Colorectal Cancer
- chemotherapy
- recombinant human endostatin
- Neoplasms
- Colorectal Neoplasms
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