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.
ABSTRACT
Objective To assess the safety and tolerance of single-dose and continuous intravenous drip of Xuesaitong saline injection in Chinese volunteers,thus to establish the effective clinical dosage.Methods Thirty-one healthy volunteers were randomized into 4 single-dose groups(100,200,400 and 600 mg respectively)and a multiple-dose group(400 mg,qd ? 14 d).Subjective symptoms,objective signs,vital signs including blood pressure,heart rate,respiration were observed,and routine blood tests,routine urine tests,hepatic function,renal function,clotting function,electrocardiogram were monitored after medication.Results In the single-dose groups,there were no abnormal findings in the vital signs and the lab examinations 0h,1h,8h,24h after medication.Dizziness without association with Xuesaitong occurring in one volunteers of the 200 mg group.It could subside after taking a rest.In the multiple-dose group,no significant changes were found in the vital signs and the lab examinations 4 d,8 d,12 d,15 d after the first dosing.Rash occurred in 2 volunteers,being considered potentially related to the drug and disappearing in one week.Conclusions Xuesaitong is safe at a dose of 100 ~ 600 mg in a single administration or at a dose of 400 mg once day for 14 days for male or female Chinese volunteers,400 mg being suggested for the clinical use.However,Further studies are needed to evaluate the safety of xuesaitong in the target population and allergic reaction should be observed.