FOLFOX4 Combined With Endostar in Patients With Advanced Colorectal Cancer
Primary Purpose
Colorectal Neoplasms
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Folfox4 plus recombinant human endostatin (Endostar)
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Colorectal Cancer, chemotherapy, recombinant human endostatin
Eligibility Criteria
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
Sites / Locations
- The Affiliated Changzhou Tumor Hospital of Suzhou UniversityRecruiting
- The Affiliated Zhongda Hospital of Southeast University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Folfox4 plus Endostar
Arm Description
Outcomes
Primary Outcome Measures
Time to progression
Secondary Outcome Measures
Full Information
NCT ID
NCT00813137
First Posted
December 19, 2008
Last Updated
December 6, 2009
Sponsor
Simcere Pharmaceutical Co., Ltd
Collaborators
The Affiliated Changzhou Tumor Hospital of Suzhou University
1. Study Identification
Unique Protocol Identification Number
NCT00813137
Brief Title
FOLFOX4 Combined With Endostar in Patients With Advanced Colorectal Cancer
Official Title
A Multi-center Study of Folfox4 Combined With Recombinant Human Endostatin(Endostar)in Advanced Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2010 (Anticipated)
Study Completion Date
October 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Simcere Pharmaceutical Co., Ltd
Collaborators
The Affiliated Changzhou Tumor Hospital of Suzhou University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
Colorectal Cancer, chemotherapy, recombinant human endostatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Folfox4 plus Endostar
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Folfox4 plus recombinant human endostatin (Endostar)
Other Intervention Name(s)
endostar, Folfox4, L-OHP, CF, 5-Fu
Intervention Description
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
Primary Outcome Measure Information:
Title
Time to progression
Time Frame
every two cycles
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Ling, M.D. Ph.D.
Email
medilyn2001@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang Ling, M.D, Ph.D
Organizational Affiliation
The Affiliated Changzhou Tumor Hospital of Suzhou University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Affiliated Changzhou Tumor Hospital of Suzhou University
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joe, M.D.
Email
joeton@21cn.com
First Name & Middle Initial & Last Name & Degree
Yang Ling, M.D, Ph.D
Facility Name
The Affiliated Zhongda Hospital of Southeast University
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
Learn more about this trial
FOLFOX4 Combined With Endostar in Patients With Advanced Colorectal Cancer
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