NCT00381862

Phase II Trial of Aprepitant & Palonosetron for CINV Prevention w FOLFOX

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: Primary * Evaluate the efficacy, in terms of nausea and vomiting control, of aprepitant, palonosetron hydrochloride, and dexamethasone, in preventing chemotherapy-induced nausea and vomiting in patients receiving FOLFOX or FOLFIRI chemotherapy for metastatic colorectal cancer. Secondary * Assess the percentage of patients with no emesis and no rescue therapy when treated with aprepitant, palonosetron hydrochloride, and dexamethasone during repeated courses of FOLFOX or FOLFIRI chemotherapy. * Assess the effects of aprepitant on nausea, appetite, taste changes (via visual analogue scale), nutritional intake, and mucositis in these patients. * Assess the safety of this regimen in these patients. OUTLINE: This is an open-label, multicenter study. Beginning 1 hour prior to the initiation of chemotherapy on day 1, patients receive oral aprepitant on days 1-3, oral dexamethasone on days 1-4, and palonosetron hydrochloride IV on day 1. Nausea is assessed daily for up to 4 courses of chemotherapy. Quality of life is assessed at baseline. PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Conditions

• Colorectal Cancer
• Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	aprepitant	Aprepitant 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle
DRUG	dexamethasone	Dexamethasone 12 mg PO on 1st day of study drug and 8 mg PO on days 2-4
DRUG	fluorouracil	as per institutional standard of care
DRUG	irinotecan hydrochloride	as per institutional standard of care
DRUG	leucovorin calcium	as per institutional standard of care
DRUG	oxaliplatin	as per institutional standard of care
DRUG	palonosetron hydrochloride	Palonosetron 0.25 mg IV push on day 1 only.
PROCEDURE	quality-of-life assessment	baseline

Timeline

• Start date: 2006-06-01
• Primary completion: 2008-03-01
• Completion: 2008-07-01
• First posted: 2006-09-28
• Last updated: 2017-06-12
• Results posted: 2011-08-10

Locations

6 sites across 1 country: United States