Phase IIa Study of Nimotuzumab Plus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer With Wild Type K-ras
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated.
within study period
Yes
Shen Lin
Principal Investigator
Department of GI Oncology,Peking University, School of Oncology, Beijing Cancer Hospital & Institute
China: Food and Drug Administration
BT-CRC-T
NCT00972465
June 2009
April 2010
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