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

Philip Philip

Status

Completed

Conditions

Nausea Post Chemotherapy

Gastrointestinal Cancer

Treatments

Drug: fosaprepitant dimeglumine

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01504711

2011-116

NCI-2011-03735 (Registry Identifier)

P30 CA022453I (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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