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

Philip Philip30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Gastrointestinal Cancer Nausea Post Chemotherapy

Interventions

fosaprepitant dimeglumineDRUG

Given IV

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Outcomes

Primary Outcomes

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.

Time frame: From 0-120 hours after first course of chemotherapy

Secondary Outcomes

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.

Time frame: 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.

Time frame: in approximately 28 months

Overall Survival

Time frame: Time of initiation of treatment until death or censor assessed up to 26 months

Data from ClinicalTrials.gov

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