FOLFOX4 Combined With Endostar in Patients With Advanced Colorectal Cancer
A Multi-center Study of Folfox4 Combined With Recombinant Human Endostatin(Endostar)in Advanced Colorectal Cancer
1 other identifier
interventional
120
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2008
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 19, 2008
CompletedFirst Posted
Study publicly available on registry
December 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedDecember 8, 2009
December 1, 2009
2 years
December 19, 2008
December 6, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to progression
every two cycles
Study Arms (1)
Folfox4 plus Endostar
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The Affiliated Changzhou Tumor Hospital of Suzhou University
Changzhou, Jiangsu, 213000, China
The Affiliated Zhongda Hospital of Southeast University
Nanjing, Jiangsu, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yang Ling, M.D, Ph.D
The Affiliated Changzhou Tumor Hospital of Suzhou University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 19, 2008
First Posted
December 22, 2008
Study Start
October 1, 2008
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
December 8, 2009
Record last verified: 2009-12