Ovarian Endometrioid Adenocarcinoma Clinical Trial
Official title:
Pilot Study of Standard Therapy for Prevention of Nausea and Emesis Associated With First Line Post-Operative Intraperitoneal Chemotherapy
This clinical trial is studying how well granisetron, aprepitant, and dexamethasone work in preventing nausea and vomiting in patients receiving chemotherapy for stage II, stage III, or stage IV ovarian cancer. Granisetron patch, aprepitant and dexamethasone may help lessen or prevent nausea and vomiting in patients receiving chemotherapy for stage II, stage III, or stage IV ovarian cancer.
PRIMARY OBJECTIVES:
I. 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.
SECONDARY OBJECTIVES:
I. To evaluate possible endpoints for the chemotherapy-induced nausea and vomiting,
including:
- Functional Living Index-Emesis (FLIE) questionnaire scores
- Mean vomiting, nausea and total FLIE scores and changes from baseline in FLIE scores
- Percentages of patients with no impact on daily living (NIDL), i.e. > 108/126 total FLIE
score II. To describe the timing of nausea and vomiting that may guide modifications to
the standard regimen.
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.
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