Ondansetron Versus Palonosetron Antiemetic Regimen Prior to Highly Emetogenic Chemotherapy(HEC)

PRIMARY OBJECTIVES:

I. The goal of this study is to evaluate the overall complete response rate (CR, no emesis and no use of rescue medication from 0 to 120 hours after chemotherapy) of two different antiemetic regimens (palonosetron + aprepitant + dexamethasone and ondansetron + aprepitant + dexamethasone) for patients undergoing the first cycle of highly emetogenic chemotherapy (HEC).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive palonosetron hydrochloride intravenously (IV) 30 minutes prior to chemotherapy on day 1, aprepitant orally (PO) 60 minutes prior to chemotherapy on days 1-3, and dexamethasone PO 30 minutes prior to chemotherapy on days 1-4.

ARM II: Patients receive ondansetron PO 30 minutes prior to chemotherapy on day 1 and aprepitant and dexamethasone as in Arm I.

After completion of study treatment, patients are followed up for 7 days.

Inclusion criteria

• Confirmed malignancy
• Chemotherapy naive or treated with only low or minimally emetogenic chemotherapy in the past (as defined by the National Comprehensive Cancer Network version [v].2.201 Antiemetic Guidelines)
• Scheduled to receive the first dose of their first cycle of HEC
• Patients receiving multi-day chemotherapy, the HEC portion must be on day 1 and the remaining days of chemotherapy must be minimally emetogenic (i.e. fluorouracil)
• Performance status of Eastern Cooperative Oncology Group (ECOG) grade 0-2
• Able to provide informed consent
• Able to read and write in English or have someone that can that can translate to them and record their diary entries
• Able to take oral medications
• Patients are allowed to participate in a concurrent clinical trial, if the other trial:

• Does not mandate an antiemetic regimen that interferes with this study
• Allows antiemetic administration at the physician's discretion
• Does not prohibit the patient from participating in this study
• Patients must be willing to participate with daily diary entries for 5 days following chemotherapy, and agree to have a 5 minute follow-up call on day 2 or 3 and day 5, 6 or 7

Exclusion criteria

• Has stage IV (metastatic) disease
• Known hypersensitivity to ondansetron, palonosetron, aprepitant, or dexamethasone
• Have received or will receive agents that are strong cytochrome P450 3A4 (CYP450 3A4) inducers and/or inhibitors and known to cause clinically relevant drug interactions within one week prior to study treatment and continuing through day 5; any vomiting or retching within 24 hours before administration of chemotherapy
• Grade 2 nausea or greater, according to the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v 4.0) within 24 hours before administration of chemotherapy
• Received an antiemetic within 24 hours before study drug administration, excluding the use of benzodiazepines
• Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2.5 times upper limit of normal
• Total bilirubin > 1.5 times upper limit of normal