Status:
COMPLETED
Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Granisetron in Cancer Patients
Lead Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Conditions:
Vomiting
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 intravenou...
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...
Eligibility Criteria
Inclusion
- 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
- Pregnancy
- Serious concomitant diseases, in the invesgator´s criteria
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00450853
Start Date
April 1 2005
End Date
November 1 2005
Last Update
January 27 2015
Active Locations (1)
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1
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain, 31008