NCT01640340

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

Pilot Study on the Efficacy of an Ondansetron Versus Palonosetron-containing Antiemetic Regimen Prior to Highly Emetogenic Chemotherapy(HEC).

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 88 Years
• Healthy volunteers: Not accepted

Summary

Palonosetron is different from ondansetron because it stays in the body longer and may prevent nausea and vomiting for a longer period of time than ondansetron. It is standard practice to use dexamethasone and aprepitant with either ondansetron or palonosetron to prevent nausea and vomiting caused by highly emetogenic chemotherapy. Although these combinations are commonly used, they have never been compared to each other. The purpose of this study is to record the amount of nausea and vomiting, and the amount of "rescue" medication that is used with these two different anti-emetic regimens

Detailed description

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.

Conditions

• Malignant Neoplasm

Interventions

Type	Name	Description
DRUG	aprepitant	Given by mouth
DRUG	palonosetron hydrochloride	Given IV(intervenous infusion)
DRUG	ondansetron	Given PO
DRUG	dexamethasone	Given PO

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2012-07-13
• Last updated: 2013-11-07
• Results posted: 2013-10-07

Locations

1 site across 1 country: United States