Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Granisetron in Cancer Patients Treated With Platinum Based Chemotherapy
5-HT3 antagonists are one of the mainstays of antiemetic treatment and they are administered
either intravenously or orally. Nevertheless sometimes neither administration route is
feasible, such as in patients unable to admit oral intake managed in an outpatient setting.
Our objective is to evaluate the bioavailability of subcutaneous granisetron.Patients
receiving platinum-based chemotherapy will be randomized to receive granisetron 3 mg either
subcutaneously or intravenously in a crossover manner during two cycles. Blood and urine
samples will be collected after each cycle. Pharmacokinetics of SC and IV granisetron will
be prospectively compared.
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Oncology Department. Clinica Universitaria de Navarra
Spain: Spanish Agency of Medicines
GRA / SC-IV