Fosaprepitant Dimeglumine in Preventing Nausea and Vomiting in Patients With Gastrointestinal Cancer Receiving Combination Chemotherapy

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 who
cannot take oral medication

- 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