Pilot Study of Fosaprepitant (MK-0517) for Breakthrough Chemotherapy Induced Nausea and Vomiting
- To evaluate the efficacy and safety of fosaprepitant dimeglumine in patients with
breakthrough chemotherapy-induced nausea and vomiting (CINV) after failing prophylactic
- To evaluate toxicity and serious adverse events associated with this regimen in these
- To evaluate the ability of patients to tolerate oral intake.
- To evaluate the health-related quality of life of patients treated with this regimen.
- To evaluate specific side effects associated with this regimen, including pain
sensation and/or soreness at the infusion site, headache, dizziness, and somnolence, in
these patients .
- To refine the study design for future phase II and III studies of rescue therapy for
breakthrough CINV using various secondary endpoints.
OUTLINE: Patients receive chemotherapy in combination with a pre-defined standard 5-HT3
antagonist or corticosteroid regimen with or without a benzodiazepine on day 1. If
breakthrough nausea or vomiting occurs, patients then receive fosaprepitant dimeglumine IV
once per standard administration guidelines. Patients with treatment response may receive
additional doses of oral aprepitant once on days 2 and 3. Patients with persistent
nausea/vomiting after 2 hours and who desire further treatment may receive standard rescue
therapy with prochlorperazine, metoclopramide, or haloperidol with or without additional
lorazepam until relief, at the discretion of the provider.
Patients complete a diary at baseline, and then at 2, 12, and 24 hours that includes a
Visual Analogue Scale (VAS) for nausea; VAS for sedation; and questions about emesis and
retching frequency, headache, dizziness, somnolence, and ability to take food and liquids
orally. Patients also complete the Functional Living Index-Emesis Quality of Life survey at
baseline and at 24 hours.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Improvement in nausea score from baseline to 2 hours as assessed by the numerical Visual Analogue Scale
Baseline to 2 hours after study drug administered.
Joseph Bubalo, PharmD, BCPS, BCOP
OHSU Knight Cancer Institute
United States: Food and Drug Administration
|Knight Cancer Institute at Oregon Health and Science University||Portland, Oregon 97239-3098|