Ignite Creation Date:
2024-05-05 @ 9:44 PM
Last Modification Date:
2024-10-26 @ 10:09 AM
Study NCT ID:
NCT00954941
Status:
COMPLETED
Last Update Posted:
2015-06-25
First Post:
2009-08-06
Brief Title:
Ondansetron Versus Aprepitant Plus Ondansetron for Emesis
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 andor 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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2009-01517 | REGISTRY | NCI CTRP | None |