Phase IIa Study of Nimotuzumab to Treat Colorectal Cancer

Status Completed

Clinical Trial Summary

Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemotherapy in patients with advanced colorectal cancer.

Clinical Trial Description

Nimotuzumab and Irinotecan will be administered to the patient until disease progression or development of toxicity preclude further treatment. Irinotecan will be administered once every 14 days, the dosage is 180mg/m2; Nimotuzumab treatment be divided 3 levels: 200mg/w, 400mg/w, 600mg/w, weekly. The patients'blood test and liver and renal function tests will be monitored weekly, a physical exam and reassessment of the tumor will be performed and every 6 weeks, when the total result is the CR or PR, the result of the 6th and the 12th week should be compared. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05278728
Study type	Interventional
Source	Biotech Pharmaceutical Co., Ltd.
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	July 2009
Completion date	December 2013

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