[Phase I study of alizapride in cancer patients treated with cisplatin].

Alizapride in a new methoxy-2 benzamide derivative with antiemetic properties. The dose-effect relationship of this compound was studied in 24 cancer patients treated with cisplatin regimens. Alizapride was administered as 15 min intravenous infusions at doses of 1 to 5 mg/kg repeated every 2 hours for 5 administrations. No adverse reactions were noted at doses of 1 to 3 mg/kg. Serious orthostatic hypotension was observed at the highest dose level. Other side effects were essentially mild to moderate and consisted of somnolence and diarrhea. The study indicated that the dosage level of 4 mg/kg is suitable for clinical use. The antiemetic activity of alizapride in patients receiving cisplatin therapy remains to be firmly established in a randomized study. This trial suggested a better antiemetic effect of alizapride in naive patients as compared to those previously treated with anticancer chemotherapy.

RCT Entities:   Population Interventions Outcomes