FOLFOX4 Combined With Endostar in Patients With Advanced Colorectal Cancer

• Status: Unknown status
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Simcere Pharmaceutical Co., Ltd
• Collaborator: The Affiliated Changzhou Tumor Hospital of Suzhou University
• Treatments: Endostar protein; Endostatins

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