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

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Treatment (nausea and vomiting prophylaxis)	fosaprepitant dimeglumine	Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy.

Primary Outcome Measures

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

Secondary Outcome Measures

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