Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Palonosetron in Cancer Treated With Chemotherapy

Study Overview
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Brief Summary
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This trial compares the pharmacokinetics of palonosetron administered subcutaneously and intravenously.

Detailed Description
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5-Hydroxitryptamine3 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 palonosetron.Patients receiving platinum-based chemotherapy will be randomized to receive palonosetron 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 subcutaneous and IV palonosetron will be prospectively compared.

Official Title
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Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous (SC) Versus Intravenous Palonosetron in Cancer Patients Treated With Platinum Based Chemotherapy

Conditions
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Emesis

Intervention / Treatment
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* Drug: Palonosetron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cancer patients receiving platinum-based chemotherapy adequate bone marrow, hepatic and renal function Exclusion Criteria: Pregnancy Serious concomitant diseases, in the invesgator´s criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravenous palonosetron<br>Intravenous palonosetron: control arm (standard treatment) | Drug: Palonosetron<br>* Palonosetron 3 mg administered SC or IV<br>|
| Experimental: subcutaneous palonosetron<br>subcutaneous palonosetron | Drug: Palonosetron<br>* Palonosetron 3 mg administered SC or IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the pharmacokinetics of a single dose of palonosetron 3mg administered either subcutaneously or intravenously by assessment of area under the curve and Cmax in cancer patients treated with emetogenic chemotherapy. |  | Palonosetron levels will be assessed at 10 , 15, 30, 45, 60 min. and 12 and 24 hours following treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficacy of a single dose of palonosetron 3mg administered either subcutaneously or intravenously by assessment of number of episodes of nausea and vomiting in cancer patients treated with emetogenic chemotherapy. |  | 1 week (post-chemotherapy) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemotherapy, emesis, palonosetron