Ondansetron Versus Palonosetron Antiemetic Regimen Prior to Highly Emetogenic Chemotherapy(HEC)
NCT ID: NCT01640340
Last Updated: 2013-11-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
40 participants
INTERVENTIONAL
2011-01-31
2011-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. The goal of this study is to evaluate the overall complete response rate (CR, no emesis and no use of rescue medication from 0 to 120 hours after chemotherapy) of two different antiemetic regimens (palonosetron + aprepitant + dexamethasone and ondansetron + aprepitant + dexamethasone) for patients undergoing the first cycle of highly emetogenic chemotherapy (HEC).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive palonosetron hydrochloride intravenously (IV) 30 minutes prior to chemotherapy on day 1, aprepitant orally (PO) 60 minutes prior to chemotherapy on days 1-3, and dexamethasone PO 30 minutes prior to chemotherapy on days 1-4.
ARM II: Patients receive ondansetron PO 30 minutes prior to chemotherapy on day 1 and aprepitant and dexamethasone as in Arm I.
After completion of study treatment, patients are followed up for 7 days.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm I (palonosetron hydrochloride)
Patients receive palonosetron hydrochloride IV 30 minutes prior to chemotherapy on day 1, aprepitant PO (by mouth) 60 minutes prior to chemotherapy on days 1-3, and dexamethasone PO 30 minutes prior to chemotherapy on days 1-4.
aprepitant
Given by mouth
palonosetron hydrochloride
Given IV(intervenous infusion)
dexamethasone
Given PO
Arm II (ondansetron)
Patients receive ondansetron PO 30 minutes prior to chemotherapy on day 1 and aprepitant and dexamethasone as in Arm I.
aprepitant
Given by mouth
ondansetron
Given PO
dexamethasone
Given PO
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
aprepitant
Given by mouth
palonosetron hydrochloride
Given IV(intervenous infusion)
ondansetron
Given PO
dexamethasone
Given PO
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Chemotherapy naive or treated with only low or minimally emetogenic chemotherapy in the past (as defined by the National Comprehensive Cancer Network version \[v\].2.201 Antiemetic Guidelines)
* Scheduled to receive the first dose of their first cycle of HEC
* Patients receiving multi-day chemotherapy, the HEC portion must be on day 1 and the remaining days of chemotherapy must be minimally emetogenic (i.e. fluorouracil)
* Performance status of Eastern Cooperative Oncology Group (ECOG) grade 0-2
* Able to provide informed consent
* Able to read and write in English or have someone that can that can translate to them and record their diary entries
* Able to take oral medications
* Patients are allowed to participate in a concurrent clinical trial, if the other trial:
* Does not mandate an antiemetic regimen that interferes with this study
* Allows antiemetic administration at the physician's discretion
* Does not prohibit the patient from participating in this study
* Patients must be willing to participate with daily diary entries for 5 days following chemotherapy, and agree to have a 5 minute follow-up call on day 2 or 3 and day 5, 6 or 7
Exclusion Criteria
* Known hypersensitivity to ondansetron, palonosetron, aprepitant, or dexamethasone
* Have received or will receive agents that are strong cytochrome P450 3A4 (CYP450 3A4) inducers and/or inhibitors and known to cause clinically relevant drug interactions within one week prior to study treatment and continuing through day 5; any vomiting or retching within 24 hours before administration of chemotherapy
* Grade 2 nausea or greater, according to the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v 4.0) within 24 hours before administration of chemotherapy
* Received an antiemetic within 24 hours before study drug administration, excluding the use of benzodiazepines
* Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 2.5 times upper limit of normal
* Total bilirubin \> 1.5 times upper limit of normal
18 Years
88 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rachel Layman
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rachel Layman
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ohio State University Medical Center
Columbus, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Jamesline
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2012-01009
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-10118
Identifier Type: -
Identifier Source: org_study_id