Oral cisapride for the control of delayed vomiting following high-dose cisplatin

Although combination antiemetics prevent vomiting during the initial 24 h a fter high-dose (greater than or equal to 100 mg/m(2)) cisplatin, many patie nts experience delayed emesis 24-120 h afterwards despite receiving prophyl actic dexamethasone and metoclopramide during this time. Cisapride is a pro kinetic agent, which stimulates propulsive motility throughout the gastroin testinal tract without causing extrapyramidal effects. In this phase II tri al, we tested the ability of cisapride to prevent delayed emesis following cisplatin. Twenty patients receiving initial cisplatin greater than or equa l to 100 mg/m(2) were entered. All patients received intravenous dexamethas one with either metoclopramide or ondansetron to prevent acute emesis 0-24 h after receiving cisplatin. Patients who had experienced two or fewer acut e vomiting episodes then received cisapride 20 mg orally four times daily f or 4 days (24-120 h after cisplatin). Cisapride prevented delayed emesis in 2 patients (10%) during the entire 4-day period (95% confidence interval, 1-32%). Abdominal cramping and gain occurred in 35%. At the dose and schedu le tested, oral cisapride prevented delayed emesis in only 10% of patients receiving cisplatin greater than or equal to 100 mg/m(2) and caused abdomin al cramping in 35%. Since in prior trials among similar patients, placebo p revented delayed emesis in 11%, further study of cisapride and dose escalat ion for this indication are not recommended.