Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Granisetron in Cancer Patients

Clinica Universidad de Navarra, Universidad de Navarra31 enrolled

Overview

Objective: 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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Vomiting

Interventions

granisetronDRUG

Granisetron SC followed by granisetron IV

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Cancer patients receiving platinum-based chemotherapy * adequate bone marrow, hepatic and renal function, respectively defined by: platelets \>100000/mm3 and absolute neutrophil count \>1500/mm3; bilirubin, AST and ALT \<2 times x upper limit of normality; and creatinine \<1.5 mg/dl. * ECOG performance status \<2 and body mass index from 20-28 kg/m2. Exclusion Criteria: * Pregnancy * Serious concomitant diseases, in the invesgator´s criteria

Locations (1)

Clinica Universitaria de Navarra

Pamplona, Navarre, Spain

Outcomes

Primary Outcomes

Bioavailability

Time frame: Approximately 6 weeks

Secondary Outcomes

Safety

Time frame: Approximately 6 weeks

Data from ClinicalTrials.gov

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