Title
Fosaprepitant Dimeglumine in Preventing Nausea and Vomiting in Patients With Gastrointestinal Cancer Receiving Combination Chemotherapy
Prevention of Nausea and Vomiting Secondary to FOLFIRINOX Chemotherapy in Gastrointestinal Cancer Patients
Phase
N/ALead Sponsor
Barbara Ann Karmanos Cancer InstituteStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Gastrointestinal Cancer Nausea Post ChemotherapyIntervention/Treatment
aprepitant ...Study Participants
30This clinical trial studies fosaprepitant dimeglumine in preventing nausea and vomiting in patients with gastrointestinal cancer receiving combination chemotherapy. Antiemetic drugs, such as fosaprepitant dimeglumine, may help lessen or prevent nausea and vomiting in patients treated with 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.
Given IV
Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy.
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
| Event Type | Organ System | Event Term | All Participants |
|---|
Achieved if a patient has no episodes of vomiting and requires no rescue medication during the first 120 hours after fosaprepitant dimeglumine administration.
Achieved if a patient has no episodes of vomiting at both 24 and 120 hours after fosaprepitant dimeglumine administration.
Achieved if a patient has no episodes of nausea at both 24 and 120 hours after fosaprepitant dimeglumine administration.
