drugset / Trial / NCT00636805
Aloxi for Prevention of Chemotherapy Induced Nausea and Vomiting in Malignant Glioma Patients Receiving Irinotecan With Bevacizumab
Phase 2
Terminated
63 enrolled
Duke University
Eisai Inc. · collabNational Institute of Neurological Disorders and Stroke (NINDS) · collab
NaSingle-groupOpen-labelSupportive care
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.
Timeline
- Start
- 2008-05
- Primary completion
- 2013-01
- Completion
- 2013-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 10 mg | Intravenous |
| Subject | Palonosetron | Other / unclassified | 0.25 mg | — |