FOLFOX4 Combined With Endostar in Patients With Advanced... | NCT00813137

Studies
FOLFOX4 Combined With Endostar in Patients With Advanced Colorectal Cancer

NCT00813137

Sponsor

Simcere Pharmaceutical Co., Ltd

Status

Unknown status

Last Update Posted

Dec 8, 2009Estimated

Enrollment

120Estimated

Phase

Phase 2

Conditions

Colorectal Neoplasms

Interventions

Folfox4 plus recombinant human endostatin (Endostar)

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Oct 2010Estimated

Completion Date

Oct 2010Estimated

First Submitted Date

Dec 19, 2008

First Submission Date that Met QC Criteria

Dec 19, 2008

First Posted Date

Dec 22, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2009

Last Update Posted Date

Dec 8, 2009Estimated

Name	Class
The Affiliated Changzhou Tumor Hospital of Suzhou University	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Folfox4 plus Endostar	Experimental		Drug: Folfox4 plus recombinant human endostatin (Endostar)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Folfox4 plus recombinant human endostatin (Endostar)	Drug	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

Measure	Description	Time Frame
Time to progression		every two cycles

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yang Ling, M.D. Ph.D.	Contact			medilyn2001@yahoo.com.cn

Overall Officials

Name	Affiliation	Role
Yang Ling, M.D, Ph.D	The Affiliated Changzhou Tumor Hospital of Suzhou University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Affiliated Changzhou Tumor Hospital of Suzhou University	Recruiting	Changzhou	Jiangsu	213000	China

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D043169	Endostatins
C522911	endostar protein
C410216	Folfox protocol
D005472	Fluorouracil

Ancestor Terms

ID	Term
D043165	Angiostatic Proteins
D042501	Angiogenic Proteins
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides

Browse Leaves

Not provided

Browse Branches

Not provided