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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
Simcere Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Colorectal Cancer, chemotherapy, recombinant human endostatin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 19, 2008
Last Updated
December 6, 2009
Sponsor
Simcere Pharmaceutical Co., Ltd
Collaborators
The Affiliated Changzhou Tumor Hospital of Suzhou University
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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

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FOLFOX4 Combined With Endostar in Patients With Advanced Colorectal Cancer

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