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

Study Overview
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Brief Summary
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This 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.

Detailed Description
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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.

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

Conditions
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Gastrointestinal Cancer, Nausea Post Chemotherapy

Intervention / Treatment
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* Drug: fosaprepitant dimeglumine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (nausea and vomiting prophylaxis)<br>Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy. | Drug: fosaprepitant dimeglumine<br>* Given IV<br>* Other names: EMEND®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Control of Vomiting and Rescue Medication Control | Achieved if a patient has no episodes of vomiting and requires no rescue medication during the first 120 hours after fosaprepitant dimeglumine administration. | From 0-120 hours after first course of chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Control of Both Acute and Delayed Vomiting | Achieved if a patient has no episodes of vomiting at both 24 and 120 hours after fosaprepitant dimeglumine administration. | in approximately 28 months | 
| Percentage of Participants With Control of Both Acute and Delayed Nausea | Achieved if a patient has no episodes of nausea at both 24 and 120 hours after fosaprepitant dimeglumine administration. | in approximately 28 months | 
| Overall Survival |  | Time of initiation of treatment until death or censor assessed up to 26 months |