Clinical trial NCT01640340: Ondansetron Versus Palonosetron Antiemetic Regimen Prior to Highly Emetogenic Chemotherapy(HEC)
Official title: Pilot Study on the Efficacy of an Ondansetron Versus Palonosetron-containing Antiemetic Regimen Prior to Highly Emetogenic Chemotherapy(HEC).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Neoplasm
Keywords: ondansetron
palonosetron
emetogenic chemotherapy
HEC
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2012-07-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: PRIMARY OBJECTIVES:

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Overall CR(Complete Response)After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication
timeFrame: Up to 120 hours after completion of chemotherapy
Secondary outcomes:
measure: Acute CR (Complete Response)
timeFrame: 0-24 hours after chemotherapy
measure: Delayed CR (Complete Response)
timeFrame: 24-120 hours after chemotherapy
measure: Percentage of Patients Who Experienced Grade 1, 2 or 3 Nausea From Time 0 to 120 Hours
timeFrame: Time 0 to 120 hours
measure: Visual Analog Scale (VAS) Scores
timeFrame: Up to 7 days after completion of study treatment
measure: Use of Rescue Medication for Each Treatment Arm
timeFrame: From time 0 to 120 hours
measure: Percentage of Patients Who Experienced Grade 1, 2 or 3 Vomiting From Time 0 to 120 Hours
timeFrame: From time 0 to 120 hours
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Rachel Layman
role: PRINCIPAL_INVESTIGATOR
References: