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

NCT00381862 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2017-06-12

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • OHSU Knight Cancer Institute

    lead OTHER

Principal Investigators

  • Joseph Bubalo, PharmD, BCPS, BCOP · OHSU Knight Cancer Institute

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2008-03-31
Completion
2008-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00381862 on ClinicalTrials.gov