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

Overview

This trial compares the pharmacokinetics of palonosetron administered subcutaneously and intravenously.

Full Title of Study: “Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous (SC) Versus Intravenous Palonosetron in Cancer Patients Treated With Platinum Based Chemotherapy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2010

Detailed Description

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.

Interventions

  • Drug: Palonosetron
    • Palonosetron 3 mg administered SC or IV

Arms, Groups and Cohorts

  • Active Comparator: Intravenous palonosetron
    • Intravenous palonosetron: control arm (standard treatment)
  • Experimental: subcutaneous palonosetron
    • subcutaneous palonosetron

Clinical Trial Outcome Measures

Primary Measures

  • 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.
    • Time Frame: Palonosetron levels will be assessed at 10 , 15, 30, 45, 60 min. and 12 and 24 hours following treatment

Secondary Measures

  • 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.
    • Time Frame: 1 week (post-chemotherapy)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Clinica Universidad de Navarra, Universidad de Navarra
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Belen Sadaba, MD, PhD, Principal Investigator, Clinica Universidad de Navarra

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