Fosaprepitant Dimeglumine in Preventing Nausea and Vomiting in Patients With Gastrointestinal Cancer Receiving Combination Chemotherapy
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.
Nausea Post Chemotherapy
Drug: fosaprepitant dimeglumine
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Prevention of Nausea and Vomiting Secondary to FOLFIRINOX Chemotherapy in Gastrointestinal Cancer Patients|
- Control of vomiting [ Time Frame: From 0-120 hours after first course of chemotherapy ] [ Designated as safety issue: No ]Achieved if a patient has no episodes of vomiting and requires no rescue medication during the first 120 hours after fosaprepitant dimeglumine administration.
- Control of acute and delayed vomiting [ Time Frame: in approximately 28 months ] [ Designated as safety issue: No ]
- Control of acute and delayed nausea [ Time Frame: in approximately 28 months ] [ Designated as safety issue: No ]
- Occurrence of any grade 3, 4 or 5 toxicity probably or definitely attributed to treatment [ Time Frame: in approximately 28 months ] [ Designated as safety issue: Yes ]
- Response rate [ Time Frame: 2 months post initiation of treatment ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Time of initiation of treatment until death or censor up to 2 months post treatment ] [ Designated as safety issue: No ]
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (nausea and vomiting prophylaxis)
Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy.
Drug: fosaprepitant dimeglumine
Other Name: EMEND®
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.
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.
I. Follow overall survival in patients receiving FOLFIRINOX chemotherapy.
Patients receive fosaprepitant dimeglumine intravenously (IV) 30 minutes prior to FOLFIRINOX chemotherapy.
After completion of study treatment, patients are followed up for 2 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01504711
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute||Recruiting|
|Detroit, Michigan, United States, 48201|
|Contact: Clinical Trials Office, MD 800-527-6266|
|Principal Investigator: Minsig Choi, MD|
|Sub-Investigator: Anthony F. Shields, MD, PhD|
|Sub-Investigator: Philip A. Philip, MD, PhD, FRCP|
|Sub-Investigator: Hemchandra Mahaseth, M.D.|
|Principal Investigator:||Minsig Choi, MD||Barbara Ann Karmanos Cancer Institute|