Clinical Study of 10-Hydroxy-Camptothecin in China: Standardized Re-Evaluation Is Necessary
GUAN Zhong zhen* Cancer Center,Sun Yat sen University of Medical Sciences,Guangzhou 510060, P.R.China
Topoisomerase Ⅰ(TOPO Ⅰ) inhibitor has become one of the most important targets of anti cancer drug research and development. One of the TOPO Ⅰ inhibitor, 10 hydroxy camptothecin (HCPT) has been marketed and put in clinical use for many years in China. However, because of historical reason, no standard phase Ⅰ and phase Ⅱ clinical studies had been carried out, and thousands of malignancy cases were treated with a combination of HCPT and other cytostatics. A preliminary review suggested that HCPT is an effective drug for various malignancies, and the adverse effects seemed less severe compared to CPT 11 or topotecan. A standard phase Ⅰ re evaluation of human tolerability and pharmacokinetics has been completed and published in this issue of the journal and a standard multi center phase Ⅱ study is going on.
【CateGory Index】： R730.53