A Pilot Study to Evaluate the Efficacy of Fosaprepitant and Granisetron Transdermal System for the Prevention of Acute and Delayed Nausea and Vomiting in Breast Cancer Patients and to Identify Predictors of Response
PRIMARY OBJECTIVES:
I. To evaluate the efficacy and safety of the combination of fosaprepitant (fosaprepitant
dimeglumine) and granisetron transdermal system in the prevention of acute and delayed
chemotherapy induced nausea and vomiting in breast cancer patients undergoing adjuvant
chemotherapy.
SECONDARY OBJECTIVES:
I. To explore the use of single nucleotide polymorphisms (SNPs) in the 5âhydroxytryptamine-3
(5HT3) and neurokinin-1 (NK-1) receptors as potential markers of efficacy.
OUTLINE: Patients receive granisetron transdermal system patch 24-48 hrs before the
initiation of chemotherapy. Patients wear the granisetron transdermal system patch for 7
days. Patients receive fosaprepitant dimeglumine intravenously (IV) over 15 minutes on day 1
of chemotherapy. Treatment repeats every 2 or 3 weeks for up to 4 courses in the absence of
unacceptable toxicity.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Proportion of patients with complete response, defined as no emesis and no use of rescue medication in acute phase (within first 24 hours of treatment)
The complete response rate with the exact 95% confidence intervals (CIs) will be calculated. The associations between the complete response rate and patient characteristics and biomarkers will be examined using Fisherâs exact test or Mann-Whitney U test whenever appropriate.
Within the first 24 hours of treatment
No
Agustin Garcia
Principal Investigator
USC/Norris Comprehensive Cancer Center
United States: Federal Government
1B-11-5
NCT01649258
September 2012
September 2015
Name | Location |
---|---|
USC Norris Comprehensive Cancer Center | Los Angeles, California 90089 |