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A Phase II Single Arm Trial of Palonosetron (PALO) for the Prevention of Acute and Delayed Chemotherapy Induced Nausea and Vomiting (CINV) in Malignant Glioma (MG) Patients Receiving Irinotecan in Combination With Bevacizumab
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.
Details
| Lead sponsor | Duke University |
|---|---|
| Phase | Phase 2 |
| Status | TERMINATED |
| Enrolment | 63 |
| Start date | 2008-05 |
| Completion | 2013-01 |
Conditions
- Brain Cancer
Interventions
- Palonosetron (Aloxi) and Dexamethasone
Primary outcomes
- Acute CINV (Chemotherapy Induced Nausea and Vomiting) CR (Complete Response) Rate — first 24 hours of the first week of chemotherapy
Acute Chemotherapy-Induced Nausea and Vomiting (CINV) complete response (CR) rate is defined as the percentage of patients who do not have an emetic episode or use antiemetic rescue medication during the first 24 hours following chemotherapy of the first cycle of treatment.
Countries
United States