Ondansetron Versus Aprepitant Plus Ondansetron for Emesis

Condition(s) targeted: Hematologic Diseases; Acute Myelogenous Leukemia; Myelodysplastic Syndrome; Chronic Myelogenous Leukemia

Intervention: Ondansetron (Drug); Aprepitant (Drug)

Phase: Phase 2

Status: Not yet recruiting

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

Overall contact:
Jorge Cortes, MD, Phone: 713-794-5783

Objectives

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.

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: Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

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).

Detailed description: 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.

Screening Tests:

Signing this consent form does not mean that you will be able to take part in this study. You will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed:

- Your medical history will be recorded.

- You will have a complete physical exam.

- Blood (about 1 teaspoon) will be drawn for routine tests.

The study doctor will discuss the screening test results with you. If the screening tests show that you are not eligible to take part in the study, you will not be enrolled. Other treatment options will be discussed with you.

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 12 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.

Additional Information:

If you take part in this study, you will need to stop taking any drugs that you are currently taking for nausea and vomiting until you receive your first dose of the study drug. You may receive other drugs for nausea and/or vomiting if the study doctor thinks it is necessary.

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 M. D. Anderson.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Jorge Cortes, MD, Phone: 713-794-5783

UT MD Anderson Cancer Center, Houston, Texas 77030, United States

UT MD Anderson Cancer Center website

Starting date: September 2009
Last updated: August 25, 2009