Phase II, open label, randomized comparative trial of ondansetron alone versus the combination of ondansetron plus aprepitant for the prevention of nausea and vomiting in patients with hematologic malignancies receiving regimens containing high-dose cytarabine
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 AML or HR-MDS who are receiving cytarabine. The safety of this drug combination will also be studied.
Disease Group: Hematologic Disorder
Treatment Agent: Aprepitant
Treatment Location: Only at MD Anderson
Estimatated Length of Stay in Houston: n/a
Return Visit: none
Home Care: n/a
Primary: To compare the efficacy and safety of ondansetron continuous infusion alone versus ondansetron continuous infusion plus aprepitant in the prevention of nausea and vomiting in patients with acute myelogenous leukemia (AML), high-risk myelodysplastic syndrome (HR-MDS), chronic myelogenous leukemia (CML) in blast crisis or acute undifferentiated leukemia receiving continuous multi-day chemotherapy with a high-dose cytarabine containing regimen. Secondary: 1. To evaluate the safety of the combination of ondansetron and aprepitant. 2. To compare the frequency and severity of vomiting and nausea between the combination of ondansetron and aprepitant and the ondansetron alone.
IRB Review and Approval Date: 11/11/2009
Recruitment Status: Not Accepting
Projected Accrual: N/A
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.
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