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

Malignant Neoplasm Clinical Trial

Official title:

Pilot Study on the Efficacy of an Ondansetron Versus Palonosetron-containing Antiemetic Regimen Prior to Highly Emetogenic Chemotherapy(HEC).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01640340
• Other study ID #: OSU-10118
• Secondary ID: NCI-2012-01009
• Status: Completed
• Phase: N/A
• First received: July 10, 2012
• Last updated: October 13, 2013
• Start date: January 2011
• Est. completion date: August 2011

Study information

• Verified date: October 2013
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 88 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Intervention

Drug:
• aprepitant
Given by mouth
• palonosetron hydrochloride
Given IV(intervenous infusion)
• ondansetron
Given PO
• dexamethasone
Given PO

Locations

Country	Name	City	State
United States	Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Acute CR (Complete Response)	After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication from time 0 to 24 hours.	0-24 hours after chemotherapy	No
Secondary	Delayed CR (Complete Response)	After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication From Time 24to 120 Hours.	24-120 hours after chemotherapy	No
Secondary	Percentage of Patients Who Experienced Grade 1, 2 or 3 Nausea From Time 0 to 120 Hours	The percentage of patients who experienced grade 1, 2 or 3 nausea from time 0 to 120 hours. Nausea graded using the National Cancer Institute (NCI) CTCAE (Common Toxicity Criteria for Adverse Effects)version 4.0 Nausea Grading Scale. Grade 1=Loss of appetite without alteration in eating habits, Grade 2= Oral intake decreased without significant weight loss, dehydration or malnutrition, Grade 3= Inadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated.	Time 0 to 120 hours	No
Secondary	Visual Analog Scale (VAS) Scores		Up to 7 days after completion of study treatment	No
Secondary	Use of Rescue Medication for Each Treatment Arm		From time 0 to 120 hours	No
Secondary	Percentage of Patients Who Experienced Grade 1, 2 or 3 Vomiting From Time 0 to 120 Hours	The percentage of patients who experienced grade 1, 2 or 3 vomiting from time 0 to 120 hours. Nausea graded using the National Cancer Institute (NCI) CTCAE v 4.0 vomiting Grading Scale. Grade 1=Loss of appetite without alteration in eating habits, Grade 2= Oral intake decreased without significant weight loss, dehydration or malnutrition, Grade 3= Inadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated.	From time 0 to 120 hours	No

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