Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Granisetron in Cancer Patients - Full Text View

Sponsor:	University of 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:	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:

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
Clinica Universitaria de Navarra
Pamplona, Navarra, Spain, 31008

Sponsors and Collaborators

University of Navarra

Investigators

Principal Investigator:

Alfonso Gurpide

Oncology Department. Clinica Universitaria de Navarra

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00450853 History of Changes
Other Study ID Numbers:	GRA / SC-IV
Study First Received:	March 21, 2007
Last Updated:	March 21, 2007
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

Additional relevant MeSH terms:

Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
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 February 12, 2012