Overview

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

Status:
Terminated

Trial end date:
2013-01-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 2

Details

Lead Sponsor:

Duke University

Collaborators:

Eisai Inc.
National Institute of Neurological Disorders and Stroke (NINDS)

Treatments:

BB 1101
Bevacizumab
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Irinotecan
Palonosetron