Phase Ⅰ study of huachansu in hepatocellular carcinoma,non-small cell lung cancer,and pancreatic cancer:a preliminary report
- VernacularTitle:华蟾素治疗肝癌、肺癌、胰腺癌的Ⅰ期临床研究:初步报道
- Author:
Zhiqiang MENG
;
Yehua SHEN
;
Peiying YANG
;
Newman ROBERT
;
Wenying BEI
;
Ying ZHANG
;
Yongqian GE
;
Cohen LORENZO
;
Kurzrock RAZELLE
;
Luming LIU
- Publication Type:Journal Article
- Keywords:
huachansu;
phase Ⅰ clinical trial;
hepatocellular carcinoma;
non-small cell lung cancer;
pancreatic cancer
- From:
China Oncology
2001;0(05):-
- CountryChina
- Language:Chinese
-
Abstract:
Background and purpose:Huachansu has been widely used to treat cancer in China.But maximum tolerated dose(MTD) of huachansu is still not well defined.The purpose of this study was to conduct a Phase Ⅰ study to determine the MTD of huachansu in the treatment of patients with hepatocellular carcinoma,non-small cell lung or pancreatic cancer.Toxic profile and efficacy of huachansu were also assessed qualitatively.Methods:Huachansu was intravenously administered to patients with stage Ⅲ/Ⅳ hepatocellular carcinoma,non-small cell lung cancer,or pancreatic cancer.Each cycle consisted of daily huachansu for 14 days with an interval of 7 days between two cycles.2 or more cycles were delivered to the patients if no severe adverse event occurred.The planned dose escalation schedule for huachansu was as follows,10,20,40,60,90 and 120 ml/(m2?d).Results:Fifteen patients(3 at each level) have been recruited to the study(11 with hepatocellular carcinoma,2 with pancreatic cancer,and 2 with lung cancer).There were no dose limiting toxicities found after dose level 5.Among all these patients,the efficacy in 14 patients could be valued,in which,6 were SD(42.9%),8 were PD(57.1%).At dose level 1,there was one patient with hepatocellular carcinoma achieving a 20% reduction in tumor mass that lasted 11 months,6 of 15(42.9%) patients with stable disease and 8 of 15(57.1%) with progress disease after the treatment.Conclusions:To date,dose limiting toxicity has not been seen with doses up to eight times higher than that typically used before.Of interest, several patients had prolonged stable disease or minor tumor shrinkage.
