Overview

This trial is active, not recruiting.

Conditions gastrointestinal cancer, nausea post chemotherapy
Treatment fosaprepitant dimeglumine
Sponsor Philip Philip
Collaborator National Cancer Institute (NCI)
Start date June 2012
End date September 2016
Trial size 42 participants
Trial identifier NCT01504711, 2011-116, NCI-2011-03735, P30 CA022453I

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy.
fosaprepitant dimeglumine EMEND®
Given IV

Primary Outcomes

Measure
Control of vomiting
time frame: From 0-120 hours after first course of chemotherapy

Secondary Outcomes

Measure
Control of acute and delayed vomiting
time frame: in approximately 28 months
Control of acute and delayed nausea
time frame: in approximately 28 months
Occurrence of any grade 3, 4 or 5 toxicity probably or definitely attributed to treatment
time frame: in approximately 28 months
Response rate
time frame: 2 months post initiation of treatment
Overall survival
time frame: Time of initiation of treatment until death or censor up to 2 months post treatment

Eligibility Criteria

Male or female participants at least 19 years old.

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

Additional Information

Official title Prevention of Nausea and Vomiting Secondary to FOLFIRINOX Chemotherapy in Gastrointestinal Cancer Patients
Principal investigator Philip A. Philip, M.D., Ph.D., F.R.C.P
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Barbara Ann Karmanos Cancer Institute.