Aloxi for Prevention of Acute and Delayed Chemotherapy Induced Nausea and Vomiting (CINV) in Malignant Glioma (MG) Patients Receiving Irinotecan With Bevacizumab
- 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.
- 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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Phase II Single Arm Trial of Palonesetron (PALO) for the Prevention of Acute and Delayed Chemotherapy Induced Nausea and Vomiting (CINV) in Malignant Glioma Patients Receiving Irinotecan in Combination With Bevacizumab|
- Response for Chemotherapy Induced nausea and vomiting [ Time Frame: two days prior and the first four days of chemo treatment and daily for 57 days ] [ Designated as safety issue: No ]
- Tolerability [ Time Frame: daily for 57 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2008|
|Estimated Study Completion Date:||January 2014|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Patient receives IV Aloxi
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.
Other Name: Aloxi
Before you receive the drug, you will have a physical exam and blood tests to determine you are able to take part. If you choose to participate in this study, you will sign a consent form. You will then get a medication called Palonosetron. Palonosetron will be given into a vein. This will take fifteen minutes. You will be given the Palonosetron and Dexamethasone 30 minutes before your first dose of Irinotecan and Bevacizumab chemotherapy. The total expected duration of your participation is 57 days. You will also be asked to complete 4 questionnaires asking questions about nausea and vomiting, your daily functioning and fatigue. You will be asked to complete these questionnaires before to starting your chemotherapy, the day you start your chemotherapy and for the next 4 days after receiving chemotherapy, for a total of 6 times. You will be asked to complete this set of questionnaires each of the 3 times that you receive chemotherapy during your 6-week treatment cycle.
The other treatments you would normally receive for your brain tumor and your routine care will not be affected by the study.
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Mary Lou Affronti, RN, MSN, ANP||Duke University|