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

Tracking Information

First Received Date ^ICMJE

March 21, 2007

Last Updated Date

March 21, 2007

Start Date ^ICMJE

April 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Bioavailability

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Safety

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Granisetron in Cancer Patients Treated With Platinum Based Chemotherapy

Brief Summary

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.

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study

Condition ^ICMJE

Vomiting

Intervention ^ICMJE

Drug: granisetron

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Spain

Administrative Information

NCT ID ^ICMJE

NCT00450853

Responsible Party

Study ID Numbers ^ICMJE

GRA / SC-IV

Study Sponsor ^ICMJE

Instituto Cientifico y Tecnologico de Navarra, Universidad de Navarra

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Alfonso Gurpide

Oncology Department. Clinica Universitaria de Navarra

Information Provided By

Instituto Cientifico y Tecnologico de Navarra, Universidad de Navarra

Verification Date

March 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP