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Aloxi for Prevention of Chemotherapy Induced Nausea and Vomiting in Malignant Glioma Patients Receiving Irinotecan With Bevacizumab

NCT00636805 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2014-04-01

Study results available
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Summary

1. Primary Objective:

* To determine the efficacy and tolerability of palonosetron and dexamethasone in preventing acute CINV in brain tumor patients during the first 24 hours of receiving Irinotecan /Bevacizumab regimens.
2. Secondary Objective

* To determine the safety and tolerability of palonosetron in brain tumor patients.
* To determine the effects of glucocorticoid and anticonvulsants on the efficacy of palonosetron.
* To determine the efficacy of palonosetron and dexamethasone in preventing delayed CINV in brain tumor patients during days 2-5.
* To determine if patients receiving palonosetron have less fatigue than baseline.

Conditions

Interventions

DRUG

Palonosetron (Aloxi) and Dexamethasone

single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy.

Sponsors & Collaborators

  • Eisai Inc.

    collaborator INDUSTRY

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Mary Lou Affronti, RN, MSN, ANP · Duke University

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • United States

Study Locations

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Diseases
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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 NCT00636805 on ClinicalTrials.gov