Prevention of Nausea and Vomiting Secondary to FOLFIRINOX Chemotherapy in Gastrointestinal Cancer Patients
19 Years
N/A
Both
Gastrointestinal Cancer, Nausea Post Chemotherapy
Trial Information
Prevention of Nausea and Vomiting Secondary to FOLFIRINOX Chemotherapy in Gastrointestinal Cancer Patients
PRIMARY OBJECTIVES:
I. To evaluate efficacy of the addition of fosaprepitant (fosaprepitant dimeglumine) in
controlling acute and delayed vomiting with the standard prophylactic anti-emetic
combination of 5-HT3 receptor antagonist and dexamethasone for gastrointestinal cancer
patients receiving FOLFIRINOX (5-FU [fluorouracil], oxaliplatin and irinotecan [irinotecan
hydrochloride]) chemotherapy.
II. To determine the rate of complete response (no emetic episode and no rescue medication)
in the combined acute and delayed phase from 0-120 hours after chemotherapy.
SECONDARY OBJECTIVES:
I. To determine the incidence of nausea and vomiting in both acute (< 24 hours) and delayed
(24- 120 hours) setting in patients receiving FOLFIRINOX chemotherapy.
TERTIARY OBJECTIVES:
I. Follow overall survival in patients receiving FOLFIRINOX chemotherapy.
OUTLINE:
Patients receive fosaprepitant dimeglumine intravenously (IV) 30 minutes prior to FOLFIRINOX
chemotherapy.
After completion of study treatment, patients are followed up for 2 months.
Inclusion Criteria:
- Patient receiving FOLFIRINOX chemotherapy
- Southwest Oncology Group (SWOG) Performance status 0 or 1
- Ability of patient or guardian to understand and to provide voluntary written
informed consent
Exclusion Criteria:
- Patient with current illness requiring chronic systemic steroids use or requiring
chronic use of anti emetics
- Patients with gastrointestinal (GI) obstruction or active peptic ulcer disease
- Known hypersensitivity to any component of the study regimen
- Patients taking any of the following medications: Oral contraceptives (except for the
administration of stopping menses), tolbutamide, phenytoin, midazolam, ketoconazole,
rifampin, paroxetine, and Diltiazem
- Pregnant or nursing women
- Patients using illegal drugs
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Control of vomiting
Outcome Description:
Achieved if a patient has no episodes of vomiting and requires no rescue medication during the first 120 hours after fosaprepitant dimeglumine administration.
Outcome Time Frame:
From 0-120 hours after first course of chemotherapy
Safety Issue:
No
Principal Investigator
Minsig Choi, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Barbara Ann Karmanos Cancer Institute
Authority:
United States: Institutional Review Board
Study ID:
2011-116
NCT ID:
NCT01504711
Start Date:
June 2012
Completion Date:
December 2014
Related Keywords:
- Gastrointestinal Cancer
- Nausea Post Chemotherapy
- Nausea
- Vomiting
- Gastrointestinal Neoplasms
Name | Location |
|---|---|
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
