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


N/A
18 Years
88 Years
Not Enrolling
Both
Malignant Neoplasm

Thank you

Trial Information

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


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.


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 [NCCN] 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall CR after the first course of HEC, defined as no emesis and no use of rescue medication

Outcome Description:

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

Outcome Time Frame:

Up to 120 hours after completion of chemotherapy

Safety Issue:

No

Principal Investigator

Rachel Layman

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Institutional Review Board

Study ID:

OSU-10118

NCT ID:

NCT01640340

Start Date:

January 2011

Completion Date:

August 2011

Related Keywords:

  • Malignant Neoplasm
  • ondansetron
  • palonosetron
  • emetogenic chemotherapy
  • HEC
  • Neoplasms

Name

Location

Ohio State University Medical CenterColumbus, Ohio  43210