Palonosetron Versus Ondansetron for the Prevention of Nausea and Vomiting

Completed · Phase 2

Conditions studied: Acute Myelogenous Leukemia, Chemotherapy-induced Nausea and Vomiting

In brief

The goal of this clinical research study is to compare the effectiveness of 3 drug schedules in preventing chemotherapy-related nausea and/or vomiting in patients with acute myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (MDS).

Key facts

Study ID

NCT01031498

Run by

M.D. Anderson Cancer Center

People needed

150

Starts

2005-09-01

Expected to finish

2009-09-01

Last updated by the study team

2012-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients > 18 years with acute myelogenous leukemia or high-risk myelodysplastic syndrome undergoing chemotherapy with high dose cytarabine (1.5 or 2gm/m\^2) containing regimens.
• Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.

You may not qualify if…

• Patients with emesis or grade 2 nausea (oral intake is significantly decreased) or 3 nausea (no significant intake requiring intravenous fluids)</= 24 hours before chemotherapy.
• Patients with ongoing emesis due to any organic etiology.
• Patients with known hypersensitivity to the study drug or to other selective 5-HT3 receptor antagonists.

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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