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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2005-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vomiting

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Granisetron SC-Granisetron IV

Granisetron SC followed by Granisetron IV

Group Type EXPERIMENTAL

granisetron

Intervention Type DRUG

Granisetron SC followed by granisetron IV

Interventions

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granisetron

Granisetron SC followed by granisetron IV

Intervention Type DRUG

Other Intervention Names

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Granisetron SC followed by granisetron IV

Eligibility Criteria

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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.