Clinical trial NCT00954941: Ondansetron Versus Aprepitant Plus Ondansetron for Emesis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hematologic Diseases
Acute Myelogenous Leukemia
Myelodysplastic Syndrome
Chronic Myelogenous Leukemia
Keywords: Hematologic Disorder
Acute myelogenous leukemia
AML
High-risk myelodysplastic syndrome
HR-MDS
Chronic Myelogenous Leukemia
CML
Ondansetron
Zofran
Aprepitant
Emend
L 754030
MK 869
Emesis
Nausea
Vomiting
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2009-08-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Cytarabine is a drug that is used to treat AML and high-risk 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.

Study Groups:

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 group.

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.

Study Diary:

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 effects occur.

Blood Draws:

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.

Eligibility 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

Primary outcomes:
measure: Participant Responses
timeFrame: First 6 treatment days
measure: Treatment Success Rate
timeFrame: First 6 treatment days
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jorge Cortes, MD
role: STUDY_CHAIR
References: