Ondansetron Versus Aprepitant Plus Ondansetron for Emesis

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to compare the effectiveness of receiving a combination of ondansetron and aprepitant to receiving ondansetron alone in helping to prevent nausea and/or vomiting in patients with Acute myeloid leukemia (AML) or high-risk (HR) Myelodysplastic syndromes (MDS) who are receiving cytarabine. The safety of this drug combination will also be studied.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Aprepitant; Fosaprepitant; Ondansetron

Criteria

Inclusion Criteria:

1. Patients greater than or equal to 18 years of age.

2. Patients with a diagnosis of acute myelogenous leukemia, high-risk myelodysplastic syndrome, chronic myelogenous leukemia in blast crisis or acute undifferentiated leukemia who will receive chemotherapy with regimens containing high-dose cytarabine (greater or equal 1g/m^2/d for at least 3 days).

3. 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.

Exclusion Criteria:

1. Patients with emesis or grade 2 or 3 nausea present less than or equal to 24 hours before chemotherapy.

2. Patients with ongoing emesis due to any organic etiology

3. Patients with known hypersensitivity to the study drug or to 5-HT3 receptor antagonists

4. Patients receiving pimozide, terfenadine, astemizole, or cisapride