Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Granisetron in Cancer Patients
This study has been completed.
Information provided by (Responsible Party):
Jose Luis Perez Gracia, Clinica Universidad de Navarra, Universidad de Navarra
First received: March 21, 2007
Last updated: May 19, 2014
Last verified: May 2014
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.
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
||Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Granisetron in Cancer Patients Treated With Platinum Based Chemotherapy
Primary Outcome Measures:
Secondary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- Serious concomitant diseases, in the invesgator´s criteria
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00450853
|Clinica Universitaria de Navarra
|Pamplona, Navarra, Spain, 31008 |
Clinica Universidad de Navarra, Universidad de Navarra
||Oncology Department. Clinica Universitaria de Navarra
No publications provided
||Jose Luis Perez Gracia, Main investigator, Clinica Universidad de Navarra, Universidad de Navarra
History of Changes
|Other Study ID Numbers:
||GRA / SC-IV
|Study First Received:
||March 21, 2007
||May 19, 2014
||Spain: Spanish Agency of Medicines
Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
Prophylaxis of emesis in patients receiving platinum-based chemotherapy
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 25, 2014
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs