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


Phase 2
18 Years
N/A
Not Enrolling
Both
Vomiting

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Trial Information

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


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.


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 invesgatorĀ“s criteria

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Bioavailability

Principal Investigator

Alfonso Gurpide

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oncology Department. Clinica Universitaria de Navarra

Authority:

Spain: Spanish Agency of Medicines

Study ID:

GRA / SC-IV

NCT ID:

NCT00450853

Start Date:

April 2005

Completion Date:

March 2007

Related Keywords:

  • Vomiting
  • emesis
  • granisetron
  • pharmacokinetics
  • subcutaneous.
  • Prophylaxis of emesis in patients receiving platinum-based chemotherapy
  • Vomiting

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