Ondansetron Versus Aprepitant Plus Ondansetron for Emesis
Information source: M.D. Anderson Cancer Center
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hematologic Diseases; Acute Myelogenous Leukemia; Myelodysplastic Syndrome; Chronic Myelogenous Leukemia
Intervention: Ondansetron (Drug); Aprepitant (Drug)
Phase: Phase 2
Sponsored by: M.D. Anderson Cancer Center
Official(s) and/or principal investigator(s):
Jorge Cortes, MD, Study Chair, Affiliation: UT MD Anderson Cancer Center
Jorge Cortes, MD, Phone: 713-794-5783
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.
Official title: Comparative Trial Ondansetron Alone Versus Combination of Ondansetron Plus Aprepitant for Prevention of Nausea and Vomiting With Hematologic Malignancies Receiving Regimens Containing High-dose Cytarabine
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Success versus Failure Rate (where success is defined no nausea, no vomiting and no need for rescue medication within the first 6 treatment days).
Cytarabine is a drug that is used to treat AML and HR-MDS. It is known to cause nausea
and/or vomiting. All patients that receive cytarabine also receive drugs to help prevent
these side effects.
The Study Drugs:
Ondansetron is designed to block the action of serotonin, a substance in the brain that
causes chemotherapy-related nausea and vomiting.
Aprepitant is designed to block a different natural substance in the brain that causes
chemotherapy-related nausea and vomiting.
If you are found eligible to take part in this study, you will be randomly assigned (as in
the flip of a coin) to 1 of 2 groups. You will have an equal chance of being in either
If you are in Group 1, you will receive ondansetron.
If you are in Group 2, you will receive ondansetron and aprepitant.
Study Drug Administration:
Both groups will receive ondansetron by vein from 30 minutes before receiving chemotherapy
until 6 to12 hours after chemotherapy. The length of the chemotherapy infusion will be
different for all patients.
If you are in Group 2, in addition to ondansetron, you will take 1 capsule of aprepitant
every morning while receiving chemotherapy. You will take your last dose of aprepitant the
day after your chemotherapy infusion is completed. If you miss a dose of aprepitant, you can
take it as soon as you remember.
You will fill out a study diary every day for the 7 days after the chemotherapy. You will
record how often you experience nausea and/or vomiting and any time you need other
medications during this study. It should take about 5 minutes to complete each time.
Length of Study:
You will be on study for up to 7 days. You will be taken off study if intolerable side
Blood (about 1 teaspoon) will be drawn for routine tests after your last dose (+/- 3 days)
of study drug.
This is an investigational study. Ondansetron and aprepitant are both FDA approved and
commercially available for the prevention of chemotherapy-related nausea and vomiting. Using
the drugs in combination is investigational.
Up to 100 participants will take part in this study. All will be enrolled at MD Anderson.
Minimum age: 18 Years.
Maximum age: 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
2. Patients with ongoing emesis due to any organic etiology
3. Patients with known hypersensitivity to the study drug or to 5-HT3 receptor
4. Patients receiving pimozide, terfenadine, astemizole, or cisapride
Locations and Contacts
Jorge Cortes, MD, Phone: 713-794-5783
UT MD Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting
Jorge Cortes, MD, Principal Investigator
UT MD Anderson Cancer Center website
Starting date: November 2009
Last updated: December 19, 2012