FOLFOX4 Combined With Endostar in Patients With Advanced Colorectal Cancer

Simcere

Status and phase: Unknown; Phase 2

Conditions: Colorectal Neoplasms

Treatments: Drug: Folfox4 plus recombinant human endostatin (Endostar)

Study type: Interventional

Funder types: Other

Identifiers

NCT00813137

simcere0803

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Folfox4 plus Endostar

Experimental group

Treatment:

Drug: Folfox4 plus recombinant human endostatin (Endostar)