CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
aprepitant +8 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01534637
NCT01534637Phase 2Completed
CompareCT.gov

A Feasibility Study to Discern the Tolerability of 5-FU/Gemcitabine Based Chemotherapy Concurrent With Upper Abdominal Radiation and the Utility of Aprepitant/5HT-3 Antagonist (EMEND) for the Prevention of ChemoRadiation-Induced Nausea and Vomiting (CRINV)

Wake Forest University Health Sciences·interventional·Posted Feb 17, 2012·Updated Aug 15, 2018

In Brief

A Phase 2 clinical trial evaluating aprepitant, gemcitabine hydrochloride, and 7 other interventions for Extrahepatic Bile Duct Cancer and 5 related conditions. Completed, enrolled 22 participants across 1 site.

Detailed Summary

This pilot clinical trial is studying how well aprepitant works in preventing nausea and vomiting in patients undergoing chemotherapy and radiation therapy for pancreatic cancer. Antiemetic drugs, such as aprepitant may help lessen or prevent nausea and vomiting in patients receiving chemotherapy and radiation therapy

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsExtrahepatic Bile Duct Cancer, Nausea, Vomiting, Stage II Pancreatic Cancer, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), Merck Sharp & Dohme LLC

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 17, 2012
Enrollment StartAug 1, 2006
Primary CompletionDec 1, 2009
Study CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 14.4 years ago

Interventions

aprepitantdrug

Given PO

gemcitabine hydrochloridedrug

Given IV

capecitabinedrug

Given PO

fluorouracildrug

Given IV

radiation therapyprocedure

Undergo radiation therapy

questionnaire administrationother

Ancillary studies

quality-of-life assessmentprocedure

Ancillary studies

nausea and vomiting therapyprocedure

Receive aprepitant

management of therapy complicationsprocedure

Receive aprepitant