NCT00636805

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Before the patients receive the palonosetron, a physical exam and blood tests are performed to determine eligibility. If eligible and willing, subjects are given Palonosetron intravenously. Subjects are given the Palonosetron and Dexamethasone 30 minutes before the first dose of Irinotecan and Bevacizumab chemotherapy. The total expected duration of participation is 57 days. Subjects are also asked to complete 4 questionnaires about nausea and vomiting, as well as daily functioning and fatigue. Subjects are asked to complete these questionnaires before starting chemotherapy, the day of starting chemotherapy and for the next 4 days after receiving chemotherapy, for a total of 6 times. Subjects are asked to complete this set of questionnaires each of the 3 times that they receive chemotherapy during the 6-week treatment cycle. The other treatments subjects would normally receive for their brain tumor and their routine care are not affected by the study.

Conditions

• Brain Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-05-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2008-03-14
• Last updated: 2014-04-01
• Results posted: 2014-04-01

Locations

1 site across 1 country: United States