Fosaprepitant Dimeglumine in Preventing Nausea and Vomiting in Patients With Gastrointestinal Cancer Receiving Combination Chemotherapy
|ClinicalTrials.gov Identifier: NCT01504711|
Recruitment Status : Active, not recruiting
First Posted : January 5, 2012
Last Update Posted : April 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Cancer Nausea Post Chemotherapy||Drug: fosaprepitant dimeglumine||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Prevention of Nausea and Vomiting Secondary to FOLFIRINOX Chemotherapy in Gastrointestinal Cancer Patients|
|Study Start Date :||June 2012|
|Estimated Primary Completion Date :||June 1, 2018|
|Estimated Study Completion Date :||June 1, 2018|
Experimental: Treatment (nausea and vomiting prophylaxis)
Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy.
Drug: fosaprepitant dimeglumine
Other Name: EMEND®
- Control of vomiting [ Time Frame: From 0-120 hours after first course of chemotherapy ]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 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01504711
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|Principal Investigator:||Philip A. Philip, M.D., Ph.D., F.R.C.P||Barbara Ann Karmanos Cancer Institute|