This phase II trial studies how well aprepitant or fosaprepitant in combination with dexamethasone and ondansetron work in preventing nausea and vomiting in patients with cancer receiving carboplatin-based chemotherapy. Giving aprepitant or fosaprepitant in addition to standard anti-nausea medications such as dexamethasone and ondansetron may help control nausea and vomiting better compared to in dexamethasone and ondansetron alone in patients receiving carboplatin-based chemotherapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03237611.
PRIMARY OBJECTIVES:
I. To determine in patients receiving their first cycle of carboplatin-based chemotherapy, the complete control rate of emesis (acute and delayed; no vomiting and no use of rescue medications) with the addition of one dose of the oral aprepitant or intravenous fosaprepitant to a combination of oral dexamethasone + an oral 5-HT3RA (ondansetron).
SECONDARY OBJECTIVES:
I. To estimate the control rate on the second cycle of this chemotherapy in those patients agreeing to be assessed in the subsequent chemotherapy cycle.
OUTLINE:
Patients receive aprepitant orally (PO) or fosaprepitant intravenously (IV) over 20 minutes immediately prior to receiving the first cycle of carboplatin-based chemotherapy. In addition, patients also receive dexamethasone PO and ondansetron PO prior to chemotherapy. Patients may optionally receive aprepitant or fosaprepitant, dexamethasone, and ondansetron during the second cycle of carboplatin-based chemotherapy.
After completion of study treatment, patients are followed up at 1 and 5 days after receiving chemotherapy.
Lead OrganizationMontefiore Medical Center-Weiler Hospital
Principal InvestigatorRichard J. Gralla
