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

This study has been completed.

First Received: March 21, 2007 No Changes Posted

Sponsored by:	Instituto Cientifico y Tecnologico de Navarra, Universidad de Navarra
Information provided by:	Instituto Cientifico y Tecnologico de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:	NCT00450853

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 II

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
Official Title:	Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Granisetron in Cancer Patients Treated With Platinum Based Chemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Nausea and Vomiting

Drug Information available for: Granisetron hydrochloride Granisetron

U.S. FDA Resources

Further study details as provided by Instituto Cientifico y Tecnologico 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

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

Locations

Spain, Navarra
Clinica Universitaria de Navarra
Pamplona, Navarra, Spain, 31008

Sponsors and Collaborators

Instituto Cientifico y Tecnologico de Navarra, Universidad de Navarra

Investigators

Principal Investigator:

Alfonso Gurpide

Oncology Department. Clinica Universitaria de Navarra

More Information

No publications provided

Study ID Numbers:	GRA / SC-IV
Study First Received:	March 21, 2007
Last Updated:	March 21, 2007
ClinicalTrials.gov Identifier:	NCT00450853 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Instituto Cientifico y Tecnologico de Navarra, Universidad de Navarra:

emesis
granisetron
pharmacokinetics
subcutaneous.
Prophylaxis of emesis in patients receiving platinum-based chemotherapy

Study placed in the following topic categories:

Neurotransmitter Agents
Vomiting
Antiemetics

Peripheral Nervous System Agents
Granisetron
Serotonin

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Antiemetics
Pharmacologic Actions
Serotonin Antagonists

Serotonin Agents
Autonomic Agents
Therapeutic Uses
Granisetron
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009