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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00954941 |
Purpose
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.
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:
| Condition | Intervention | Phase |
|---|---|---|
|
Hematologic Diseases Acute Myelogenous Leukemia Myelodysplastic Syndrome Chronic Myelogenous Leukemia |
Drug: Ondansetron Drug: Aprepitant |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Estimated Enrollment: | 100 |
| Study Start Date: | November 2009 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Group 1: Ondansetron |
Drug: Ondansetron
8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
Other Name: Zofran
|
| Active Comparator: Group 2: Ondansetron + Aprepitant |
Drug: Ondansetron
8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
Other Name: Zofran
Drug: Aprepitant
125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.
Other Names:
|
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.
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jorge Cortes, MD | 713-794-5783 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Jorge Cortes, MD | |
| Study Chair: | Jorge Cortes, MD | UT MD Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00954941 History of Changes |
| Other Study ID Numbers: | 2008-0615 |
| Study First Received: | August 6, 2009 |
| Last Updated: | January 25, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
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 |
|
Hematologic Diseases Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Myelodysplastic Syndromes Preleukemia Neoplasms by Histologic Type Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Precancerous Conditions Ondansetron Aprepitant Antiemetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents Antipruritics Dermatologic Agents Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antipsychotic Agents Tranquilizing Agents |
