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This phase II trial assessed the cardiovascular safety and tolerability of high-dose granisetron for the treatment of nausea and vomiting in cancer patients undergoing emetogenic chemotherapy. Forty-one patients were given 30-min infusions of granisetron, 40 or 120 microg/kg i.v., as either a single dose or as split doses, at 6-h intervals. Subsequently, patients had the option of the alternative dosing regimen or to return to conventional antiemetic therapy. Patients were monitored for 24 h following the first granisetron infusion. Electrocardiogram (ECG; lead II and Holter monitoring) measurements were made during the study and blood samples for pharmacokinetic analysis were taken at regular intervals for 48 h after the start of the first granisetron infusion. During the first chemotherapy session, granisetron was administered as: (i) bolus doses of 80 microg/kg (n=3) and 120 microg/kg (n=19) or (ii) split doses of 2x40 microg/kg (n=1) and 3x40 microg/kg (n=18). Crossover therapy was administered to 22 patients, with granisetron doses of 120 microg/kg (n=12), 2x40 microg/kg (n=1) and 3x40 microg/kg (n=9). We conclude that supra-therapeutic doses up to 120 microg/kg granisetron had no clinically significant effect on ECG, pulse rate or blood pressure. The treatment was well tolerated with no significant changes in biochemistry or hematological parameters.

Original publication

DOI

10.1097/01.cad.0000092783.37568.4d

Type

Journal article

Journal

Anticancer drugs

Publication Date

10/2003

Volume

14

Pages

739 - 744

Keywords

Adolescent, Adult, Aged, Antiemetics, Antineoplastic Agents, Cross-Over Studies, Dose-Response Relationship, Drug, Drug Administration Schedule, Electrocardiography, Female, Granisetron, Humans, Male, Middle Aged, Vomiting