Ondansetron Versus Palonosetron Antiemetic Regimen Prior to Highly Emetogenic Chemotherapy(HEC)

NCT01640340 | Completed Results DMC

• 2 other identifiers: OSU-10118NCI-2012-01009
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Palonosetron is different from ondansetron because it stays in the body longer and may prevent nausea and vomiting for a longer period of time than ondansetron. It is standard practice to use dexamethasone and aprepitant with either ondansetron or palonosetron to prevent nausea and vomiting caused by highly emetogenic chemotherapy. Although these combinations are commonly used, they have never been compared to each other. The purpose of this study is to record the amount of nausea and vomiting, and the amount of "rescue" medication that is used with these two different anti-emetic regimens

Conditions

Malignant Neoplasm

Keywords

ondansetron; palonosetron; emetogenic chemotherapy; HEC

Outcome Measures

Primary Outcomes (1)

• Overall CR(Complete Response)After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication

  We will use exact binomial methods to estimate proportions and their associated 95% confidence intervals.

  Up to 120 hours after completion of chemotherapy

Secondary Outcomes (6)

• Acute CR (Complete Response)

  0-24 hours after chemotherapy

• Delayed CR (Complete Response)

  24-120 hours after chemotherapy

• Percentage of Patients Who Experienced Grade 1, 2 or 3 Nausea From Time 0 to 120 Hours

  Time 0 to 120 hours

• Visual Analog Scale (VAS) Scores

  Up to 7 days after completion of study treatment

• Use of Rescue Medication for Each Treatment Arm

  From time 0 to 120 hours

Study Arms (2)

Arm I (palonosetron hydrochloride)

EXPERIMENTAL

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.

Drug: aprepitant; Drug: palonosetron hydrochloride; Drug: dexamethasone

Arm II (ondansetron)

EXPERIMENTAL

Patients receive ondansetron PO 30 minutes prior to chemotherapy on day 1 and aprepitant and dexamethasone as in Arm I.

Drug: aprepitant; Drug: ondansetron; Drug: dexamethasone

Interventions

aprepitant DRUG

Given by mouth

Also known as: Emend, L-754030, MK-0869, ONO-7436

Arm I (palonosetron hydrochloride); Arm II (ondansetron)

palonosetron hydrochloride DRUG

Given IV(intervenous infusion)

Also known as: Aloxi, RS 25259-197

Arm I (palonosetron hydrochloride)

ondansetron DRUG

Given PO

Also known as: GR 38032F, GR-C507/75, Zofran

Arm II (ondansetron)

dexamethasone DRUG

Given PO

Also known as: Aeroseb-Dex, Decaderm, Decadron, DM, DXM

Arm I (palonosetron hydrochloride); Arm II (ondansetron)

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed malignancy
• 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

You may not qualify if:

• Has stage IV (metastatic) disease
• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Links

• Jamesline

MeSH Terms

Conditions

Neoplasms

Interventions

Aprepitant; Palonosetron; Ondansetron; Dexamethasone; Calcium Dobesilate

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Imidazoles; Azoles; Carbazoles; Indoles; Heterocyclic Compounds, 3-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Rachel Layman, MD
• Organization: Ohio State University Medical Center

Rachel.Layman@osumc.edu

614-293-0066

Study Officials

• Rachel Layman

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2012
• First Posted: July 13, 2012
• Study Start: January 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: November 7, 2013
• Results First Posted: October 7, 2013

Record last verified: 2013-10

Locations

US (1)