Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Granisetron in Cancer Patients
Information source: University of Navarre
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vomiting
Intervention: granisetron (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of Navarre Official(s) and/or principal investigator(s):
Alfonso Gurpide, Principal Investigator, Affiliation: Oncology Department. Clinica Universitaria de Navarra
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.
Clinical Details
Official title: Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Granisetron in Cancer Patients Treated With Platinum Based Chemotherapy
Study design: Supportive Care, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
Primary outcome: Bioavailability
Secondary outcome: Safety
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Clinica Universitaria de Navarra, Pamplona, Navarra 31008, Spain
Additional Information
Starting date: April 2005
Ending date: March 2007
Last updated: March 21, 2007
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