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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jose Luis Perez Gracia, Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT00450853
First received: March 21, 2007
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Vomiting
Drug: granisetron
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Granisetron in Cancer Patients Treated With Platinum Based Chemotherapy

Resource links provided by NLM:


Further study details as provided by Clinica Universidad de Navarra, Universidad de Navarra:

Primary Outcome Measures:
  • Bioavailability

Secondary Outcome Measures:
  • Safety

Estimated Enrollment: 25
Study Start Date: April 2005
Estimated Study Completion Date: March 2007
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00450853

Locations
Spain
Clinica Universitaria de Navarra
Pamplona, Navarra, Spain, 31008
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Investigators
Principal Investigator: Alfonso Gurpide Oncology Department. Clinica Universitaria de Navarra
  More Information

No publications provided

Responsible Party: Jose Luis Perez Gracia, Main investigator, Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT00450853     History of Changes
Other Study ID Numbers: GRA / SC-IV
Study First Received: March 21, 2007
Last Updated: May 19, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
emesis
granisetron
pharmacokinetics
subcutaneous.
Prophylaxis of emesis in patients receiving platinum-based chemotherapy

Additional relevant MeSH terms:
Granisetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014