Prevention of Nausea and Vomiting Secondary to FOLFIRINOX Chemotherapy in Gastrointestinal Cancer Patients
I. To evaluate efficacy of the addition of fosaprepitant (fosaprepitant dimeglumine) in
controlling acute and delayed vomiting with the standard prophylactic anti-emetic
combination of 5-HT3 receptor antagonist and dexamethasone for gastrointestinal cancer
patients receiving FOLFIRINOX (5-FU [fluorouracil], oxaliplatin and irinotecan [irinotecan
II. To determine the rate of complete response (no emetic episode and no rescue medication)
in the combined acute and delayed phase from 0-120 hours after chemotherapy.
I. To determine the incidence of nausea and vomiting in both acute (< 24 hours) and delayed
(24- 120 hours) setting in patients receiving FOLFIRINOX chemotherapy.
I. Follow overall survival in patients receiving FOLFIRINOX chemotherapy.
Patients receive fosaprepitant dimeglumine intravenously (IV) 30 minutes prior to FOLFIRINOX
After completion of study treatment, patients are followed up for 2 months.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Control of vomiting
Achieved if a patient has no episodes of vomiting and requires no rescue medication during the first 120 hours after fosaprepitant dimeglumine administration.
From 0-120 hours after first course of chemotherapy
Minsig Choi, MD
Barbara Ann Karmanos Cancer Institute
United States: Institutional Review Board
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|