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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
4
Ancillary studies
Given IV and PO
Given IP
Given IP
Given PO
Apply one patch to upper arm
Ancillary studies
Ancillary studies
Sudarshan K Sharma MD Limted-Gynecologic Oncology
Hinsdale, Illinois, United States
Women and Infants Hospital
Providence, Rhode Island, United States
Number of Participants With Complete Control Defined as no Vomiting and no Use of Rescue Medications (for Nausea or Emesis)
Number of participants who had complete control defined by no vomiting
Time frame: During the 6 days following chemotherapy
Change in Vomiting, Nausea and Total FLIE Scores
Time frame: Baseline to day 6
Frequency of Adverse Effects as Assessed by the NCI CTCAE v 4.0
Adverse events at least possibly related to treatment
Time frame: Up to day 6
Mean and Standard Deviation of Vomiting, Nausea, and Total FLIE Scores
Time frame: Baseline
Percentages of Patients With NIDL Based on FLIE
Time frame: Up to day 6
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