NEWS HIGHLIGHTSMedia Articles Related to Aloxi (Palonosetron)
Nausea and Vomiting
Source: MedicineNet Antiemetics Specialty [2008.04.29]
Title: Nausea and Vomiting
Category: Diseases and Conditions
Created: 1/31/2005 8:21:00 AM
Last Editorial Review: 4/29/2008
Published Studies Related to Aloxi (Palonosetron)
Randomized, placebo-controlled, pilot study evaluating aprepitant single dose plus palonosetron and dexamethasone for the prevention of acute and delayed chemotherapy-induced nausea and vomiting. [2008.05.01]
BACKGROUND: The combination of palonosetron and aprepitant is safe and effective in the prevention of chemotherapy-induced emesis (CIE). The purpose of this pilot study was to ascertain the effectiveness of 1-day versus 3-day aprepitant in the prevention of acute and delayed nausea and vomiting in patients who were receiving highly emetogenic chemotherapy... CONCLUSIONS: From this pilot study of patients who were receiving palonosetron, aprepitant, and dexamethasone for highly emetogenic chemotherapy, a single dose of aprepitant displayed similar effectiveness compared with 3-day aprepitant.
Randomized, placebo-controlled, pilot study evaluating aprepitant single dose plus palonosetron and dexamethasone for the prevention of acute and delayed chemotherapy-induced nausea and vomiting. [2008.03.07]
BACKGROUND.: The combination of palonosetron and aprepitant is safe and effective in the prevention of chemotherapy-induced emesis (CIE). The purpose of this pilot study was to ascertain the effectiveness of 1-day versus 3-day aprepitant in the prevention of acute and delayed nausea and vomiting in patients who were receiving highly emetogenic chemotherapy...
A phase III, double-blind, randomized trial of palonosetron compared with ondansetron in preventing chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy. [2006.09]
BACKGROUND: This pivotal phase III trial evaluated the efficacy and safety of palonosetron in preventing acute and delayed chemotherapy-induced nausea and vomiting (CINV) following highly emetogenic chemotherapy (HEC)... CONCLUSIONS: Single-dose palonosetron was as effective as ondansetron in preventing acute CINV following HEC, and with dexamethasone pre-treatment, its effectiveness was significantly increased over ondansetron throughout the 5-day post-chemotherapy period.
Palonosetron improves prevention of chemotherapy-induced nausea and vomiting in elderly patients. [2005.09]
Although elderly patients have been reported to be less prone to chemotherapy-induced nausea and vomiting (CINV), its management is complicated by a high frequency of comorbidities and polypharmacy and an increased risk of dehydration and impaired cognition.The comparative efficacy and tolerability of palonosetron and ondansetron/dolasetron were assessed in a retrospective post hoc analysis using pooled data from 171 elderly patients (age > or = 65 years) with cancer enrolled in two randomized, double-blind, phase III clinical studies comparing single IV doses of these antiemetic agents given prior to receipt of moderately emetogenic chemotherapy.The complete response rate during the postchemotherapy period was significantly higher in the palonosetron group than in the ondansetron/dolasetron group in the 5 days following chemotherapy.The proportion of patients who were nausea-free on the problematic days 2 and 3 post chemotherapy and the time to treatment failure also significantly favored palonosetron.
Evaluation of safety and pharmacokinetics of consecutive multiple-day dosing of palonosetron in healthy subjects. [2005.05]
This study evaluated the safety and pharmacokinetics of consecutive multiple-day dosing of palonosetron... The 2.1-fold accumulation of palonosetron in plasma following 3 daily doses was predictable based on elimination half-life of approximately 40 hours, and the maximum plasma concentration remained below the maximum plasma concentration previously observed after a single, well-tolerated 0.75 mg intravenous bolus dose of palonosetron.
Clinical Trials Related to Aloxi (Palonosetron)
Palonosetron in Sarcoma Patients Receiving Chemotherapy With Adriamycin and Ifosfamide (AI) [Recruiting]
Efficacy of Intravenous (IV) Palo With IV Dexamethasone Versus IV Palo for Prevention of Immediate and Delayed Post-Operative Nausea/Vomiting [Recruiting]
The purpose of this study is to determine if subjects who receive Palonosetron plus
Dexamethasone have less post-operative nausea and vomiting (PONV) than those who receive
Palonosetron alone.
Aloxi for Prevention of Acute and Delayed Chemotherapy Induced Nausea and Vomiting (CINV) in Malignant Glioma (MG) Patients Receiving Irinotecan With Bevacizumab [Recruiting]
Intravenous Palonosetron With Radiotherapy and Concomitant Temozolomide [Not yet recruiting]
1. Purpose and objective:
1. To determine the safety and tolerability of palonosetron in the prevention of radiation
induced nausea and vomiting (RINV) in primary glioma patients receiving radiation (RT)
and concomitant temozolomide (TMZ).
2. To determine the efficacy of palonosetron in primary glioma patients receiving six
weeks of RT and concomitant TMZ
3. To evaluate the effect s of palonosetron on the quality of life of primary glioma
patients receiving six weeks of RT and Concomitant TMZ.
2. Study activities and Population group: We will conduct a phase II single arm trial of
Palonosetron (PALO) for the prevention of RINV in primary malignant glioma patients
receiving radiation therapy (RT) and concomitant temozolomide (TMZ). All eligible patients
should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily
temozolomide for a total of six weeks of treatment. For each week of radiation patients will
receive a single 0. 25 mg intravenous dose of palonosetron 30 minutes before each week of
radiation fraction. This schedule will be repeated for each week of radiation for a total of
6 weeks. Forty subjects with gliomas will participate.
3. Data analysis and risk/safety issues: The frequency of toxicity will be summarized by
type and the most severe grade experienced. The complete response rate, defined as the
proportion of patients with no emetic episode or use of rescue medication while receiving
radiation and concomitant temozolomide, will be estimated with a 95% confidence interval.
Logistic regression will be used to explore the effect of age, sex, the use of
glucocorticoids and anti convulsants, on the complete response rate.
Palonosetron for the Treatment of Nausea and Vomiting in Terminally Ill Patients [Not yet recruiting]
The primary objective of this study is to determine the complete response (no vomiting and
no need for other medications to treat nausea) in terminally ill patients suffering from
nausea and/or vomiting, who are treated with palonosetron. Another objective is to
determine the partial response (relief of nausea and vomiting to the extent that you wish to
continue treatment with palonosetron) after being treated with palonosetron. Palonosetron is
currently approved by the FDA to prevent nausea and vomiting associated with chemotherapy.
The investigators are testing this medication to see if it can help to relieve nausea and
vomiting not associated with chemotherapy, too.
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