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

Gastrointestinal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01504711
• Other study ID #: 2011-116
• Secondary ID: NCI-2011-03735P3
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: September 3, 2020

Study information

• Verified date: September 2020
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 3, 2020
• Est. primary completion date: December 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

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

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Nausea
• Nausea Post Chemotherapy
• Vomiting

Intervention

Drug:
• fosaprepitant dimeglumine
Given IV

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Philip Philip	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Overall Survival		Time of initiation of treatment until death or censor assessed up to 26 months