Ondansetron Versus Aprepitant Plus Ondansetron for Emesis - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by:	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:

To evaluate the safety of the combination of ondansetron and aprepitant.
To compare the frequency and severity of vomiting and nausea between the combination of ondansetron and aprepitant and the ondansetron alone.

Condition	Intervention	Phase
Hematologic Diseases Acute Myelogenous Leukemia Myelodysplastic Syndrome Chronic Myelogenous Leukemia	Drug: Ondansetron Drug: Aprepitant	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Nausea and Vomiting

Drug Information available for: Ondansetron hydrochloride Ondansetron Aprepitant

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Success versus Failure Rate (where success is defined no nausea, no vomiting and no need for rescue medication within the first 6 treatment days). [ Time Frame: Continuous monitoring within first 6 treatment days ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	November 2009
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Ondansetron: Experimental	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.
Group 2: Ondansetron + Aprepitant: Active Comparator	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. 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.

Arms

Assigned Interventions

Group 1: Ondansetron: Experimental

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.

Group 2: Ondansetron + Aprepitant: Active Comparator

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.

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.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients greater than or equal to 18 years of age.
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).
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:

Patients with emesis or grade 2 or 3 nausea present less than or equal to 24 hours before chemotherapy.
Patients with ongoing emesis due to any organic etiology
Patients with known hypersensitivity to the study drug or to 5-HT3 receptor antagonists
Patients receiving pimozide, terfenadine, astemizole, or cisapride

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954941

Contacts

Contact: Jorge Cortes, MD

713-794-5783

Locations

United States, Texas
UT MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Jorge Cortes, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Study Chair:

Jorge Cortes, MD

UT MD Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UT MD Anderson Cancer Center ( Jorge Cortes, MD / Professor )
Study ID Numbers:	2008-0615
Study First Received:	August 6, 2009
Last Updated:	November 11, 2009
ClinicalTrials.gov Identifier:	NCT00954941 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

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

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Precancerous Conditions
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Leukemia, Myeloid, Acute
Leukemia
Serotonin Antagonists
Preleukemia
Pathologic Processes
Syndrome
Therapeutic Uses
Antipruritics
Ondansetron

Dermatologic Agents
Aprepitant
Tranquilizing Agents
Neoplasms by Histologic Type
Disease
Hematologic Diseases
Myelodysplastic Syndromes
Myeloproliferative Disorders
Gastrointestinal Agents
Central Nervous System Depressants
Leukemia, Myeloid
Antipsychotic Agents
Pharmacologic Actions
Neoplasms
Serotonin Agents

ClinicalTrials.gov processed this record on February 09, 2010