CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 54 enrolled
Drug / intervention
aprepitant +7 moredrug
Likely dose
aprepitant 125 mgfrom 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/NCT00381862
NCT00381862Phase 2Completed

A Multi-Center, Trial to Evaluate the Efficacy & Tolerability of Aprepitant and Palonosetron for the Prevention of CINV in Colorectal Cancer (CRC) Patients Receiving FOLFOX

OHSU Knight Cancer Institute·interventional·Posted Sep 28, 2006·Updated Jun 12, 2017

In Brief

A Phase 2 clinical trial evaluating aprepitant, dexamethasone, and 6 other interventions for Colorectal Cancer and Nausea and Vomiting. Completed, enrolled 54 participants across 6 sites.

Detailed Summary

RATIONALE: Aprepitant, palonosetron, and dexamethasone may help lessen or prevent nausea and vomiting in patients receiving chemotherapy. PURPOSE: This phase II trial is studying how well giving aprepitant together with palonosetron and dexamethasone works in preventing nausea and vomiting caused by chemotherapy in patients receiving chemotherapy for metastatic colorectal cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 28, 2006
Enrollment StartJun 1, 2006
Primary CompletionMar 1, 2008
Study CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.8 years ago

Interventions

aprepitantdrug

Aprepitant 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle

dexamethasonedrug

Dexamethasone 12 mg PO on 1st day of study drug and 8 mg PO on days 2-4

fluorouracildrug

as per institutional standard of care

irinotecan hydrochloridedrug

as per institutional standard of care

leucovorin calciumdrug

as per institutional standard of care

oxaliplatindrug

as per institutional standard of care

palonosetron hydrochloridedrug

Palonosetron 0.25 mg IV push on day 1 only.

quality-of-life assessmentprocedure

baseline