Palonosetron in Moderately and Highly Emetogenic Chemotherapy Induced Nausea and Vomiting (Study P04935)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of single IV doses of Onicit® (Palonosetron) 0.25 mg in the prevention of acute and delayed nausea and vomiting associated with moderate and highly emetogenic chemotherapy.

Official Title
-----------------
Study to Evaluate the Efficacy and Safety of Single IV Doses of Onicit® (Palonosetron) 0.25 mg in the Prevention of Acute and Delayed Nausea and Vomiting Associated With Moderate and Highly Emetogenic Chemotherapy in Colombia

Conditions
-----------------
Neoplasms, Nausea, Vomiting

Intervention / Treatment
-----------------
* Drug: Palonosetron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be 18 years of age or older. Histological or cytological confirmation of malignant disease. Karnofsky index >= 50% Naïve to chemotherapy (First Cycle of chemotherapy IV with moderate or high emetic risk administered during Day 1 of the study, according to modification of the classification of Paul Hesketh's schema published on Annals of Oncology 17: 20-28, 2006 (Appendix 3). Patients that voluntarily sign the consent form. Exclusion Criteria: Pregnancy or suspected. Patients during breast feeding. Inability to understand or cooperate with the study procedures. Received any investigational drugs within 30 days before study entry. Received any drug with potential anti-emetic efficacy within 24 hours prior to the beginning of the treatment Seizure disorders requiring anticonvulsant medication. Persistent vomiting due to any organic etiology. Experienced any vomiting, nausea or retching, in the 24 hours prior to chemotherapy. Any systemic disease different to base disease Known current or history of drug or alcohol abuse Gastric outlet or intestinal obstruction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Palonosetron<br>0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent | Drug: Palonosetron<br>* 0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent.<br>* Other names: SCH 734291 - Onicit®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients having achieved complete response (CR), defined as no emetic episodes and no rescue medication. |  | During 24 hours after administration of chemotherapy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who achieved a CR and of those who achieved complete control |  | Days 1 to 5 at different time intervals for each secondary outcome. | 
| Number of emetic episodes |  | Days 1 to 5 at different time intervals for each secondary outcome. | 
| Time to first emetic episode; time to administration and need for rescue therapy; and to treatment failure time to first emetic episode or administration of rescue medication |  | Days 1 to 5 at different time intervals for each secondary outcome. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antiemetic