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Prevention of Nausea and Vomiting Secondary to FOLFIRINOX Chemotherapy in Gastrointestinal Cancer Patients


N/A
19 Years
N/A
Open (Enrolling)
Both
Gastrointestinal Cancer, Nausea Post Chemotherapy

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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 InstituteDetroit, Michigan  48201