N/A
N=40
Ondansetron Versus Palonosetron Antiemetic Regimen Prior to Highly Emetogenic Chemotherapy(HEC)
Malignant Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT01640340 ↗Enrolled (actual)
40
Serious AEs
2.5%
Results posted
Oct 2013
Primary outcome: Primary: Overall CR(Complete Response)After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication — 65; 40 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- aprepitant (Drug); palonosetron hydrochloride (Drug); ondansetron (Drug); dexamethasone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall CR(Complete Response)After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication |
65; 40 | — |
| SECONDARY Acute CR (Complete Response) |
75; 55 | — |
| SECONDARY Delayed CR (Complete Response) |
65; 45 | — |
| SECONDARY Percentage of Patients Who Experienced Grade 1, 2 or 3 Nausea From Time 0 to 120 Hours |
55; 65 | — |
| SECONDARY Visual Analog Scale (VAS) Scores |
— | — |
| SECONDARY Use of Rescue Medication for Each Treatment Arm |
35; 55 | — |
| SECONDARY Percentage of Patients Who Experienced Grade 1, 2 or 3 Vomiting From Time 0 to 120 Hours |
5; 15 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT01640340). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.