Pilot Study of Standard Therapy for Prevention of Nausea and Emesis Associated With First Line Post-Operative Intraperitoneal Chemotherapy
- To determine the frequency of chemotherapy-induced nausea and vomiting based on
complete response (no vomiting and no use of rescue therapy) during the 6 days
following intraperitoneal (IP) chemotherapy for the 3-day regimen of aprepitant (both
injection and capsules) in combination with granisetron transdermal system and
dexamethasone in ovarian cancer patients receiving IP cisplatin OR IP carboplatin.
- To evaluate possible endpoints for the chemotherapy-induced nausea and vomiting,
including Functional Living Index-Emesis (FLIE) questionnaire scores.
- To evaluate mean vomiting, nausea, and total FLIE scores and changes from baseline in
- To evaluate the percentage of patients with no impact on daily living (NIDL) (i.e., >
108/126 total FLIE score).
- To describe the timing of nausea and vomiting that may guide modifications to the
OUTLINE: This is a multicenter study.
Patients apply one patch of granisetron transdermal system to the upper outer arm on day 0
(at least 24 hours before intraperitoneal [IP] platinum therapy). Patients then receive
dexamethasone orally (PO) on days 1-4, aprepitant IV over 15 minutes on day 1 (30 minutes
before IP platinum therapy), and aprepitant PO on days 2-3.
Patients complete the Functional Living Index--Emesis (FLIE) and a symptom diary at baseline
and on days 3 and 6.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Supportive Care
Complete control of chemotherapy-induced nausea and vomiting
Steven C. Plaxe, MD
University of California, San Diego
United States: Federal Government