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FOLFOX4 Combined With Endostar in Patients With Advanced Colorectal Cancer

NCT ID: NCT00813137

Last Updated: 2009-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-10-31

Brief Summary

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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

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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.

Conditions

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Colorectal Neoplasms

Keywords

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Colorectal Cancer chemotherapy recombinant human endostatin

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Folfox4 plus Endostar

Group Type EXPERIMENTAL

Folfox4 plus recombinant human endostatin (Endostar)

Intervention Type 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

Interventions

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Folfox4 plus recombinant human endostatin (Endostar)

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

Intervention Type DRUG

Other Intervention Names

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endostar Folfox4 L-OHP CF 5-Fu

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Changzhou Tumor Hospital of Suzhou University

UNKNOWN

Sponsor Role collaborator

Simcere Pharmaceutical Co., Ltd

OTHER

Sponsor Role lead

Responsible Party

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the Affiliated Changzhou Tumor Hospital of Suzhou University

Principal Investigators

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Yang Ling, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Changzhou Tumor Hospital of Suzhou University

Locations

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The Affiliated Changzhou Tumor Hospital of Suzhou University

Changzhou, Jiangsu, China

Site Status RECRUITING

The Affiliated Zhongda Hospital of Southeast University

Nanjing, Jiangsu, China

Site Status ACTIVE_NOT_RECRUITING

Countries

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China

Central Contacts

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Yang Ling, M.D. Ph.D.

Role: CONTACT

Email: [email protected]

Facility Contacts

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Joe, M.D.

Role: primary

Other Identifiers

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simcere0803

Identifier Type: -

Identifier Source: org_study_id