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

Primary Purpose

Vomiting

Status

Completed

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

granisetron

About this trial

This is an interventional supportive care trial for Vomiting focused on measuring emesis, granisetron, pharmacokinetics, subcutaneous.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Clinica Universitaria de Navarra

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Granisetron SC-Granisetron IV

Arm Description

Granisetron SC followed by Granisetron IV

Outcomes

Primary Outcome Measures

Bioavailability

Secondary Outcome Measures

Safety

Full Information

NCT ID

NCT00450853

First Posted

March 21, 2007

Last Updated

January 26, 2015

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

1. Study Identification

Unique Protocol Identification Number

NCT00450853

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

April 2005 (undefined)

Primary Completion Date

November 2005 (Actual)

Study Completion Date

November 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vomiting

Keywords

emesis, granisetron, pharmacokinetics, subcutaneous.

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Granisetron SC-Granisetron IV

Arm Type

Experimental

Arm Description

Granisetron SC followed by Granisetron IV

Intervention Type

Drug

Intervention Name(s)

granisetron

Other Intervention Name(s)

Granisetron SC followed by granisetron IV

Intervention Description

Granisetron SC followed by granisetron IV

Primary Outcome Measure Information:

Title

Bioavailability

Time Frame

Approximately 6 weeks

Secondary Outcome Measure Information:

Title

Safety

Time Frame

Approximately 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alfonso Gurpide

Organizational Affiliation

Oncology Department. Clinica Universitaria de Navarra

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinica Universitaria de Navarra

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

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

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