Safety and Efficacy of Palonosetron in Preventing Chemotherapy-induced Nausea and Vomiting

Study Overview
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Brief Summary
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The purpose of this study is to determine whether palonosetron is tolerate and effective in preventing chemotherapy-induced nausea and vomiting in oriental population. The study is comparing the safety and efficacy of palonosetron with granisetron, a frequently used antiemetic in China.

Official Title
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A Phase II,Multicenter,Randomized,Double-blind,Cross-over Study of Palonosetron Compared With Granisetron in Prevention of Chemotherapy-induced Nausea and Vomiting in Asian Population

Conditions
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Nausea, Vomiting, Chemotherapy

Intervention / Treatment
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* Drug: Palonosetron
* Drug: Granisetron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, age ≥ 18 yrs and <70 yrs with histologically or cytologically confirmed Malignant disease Naive or nonnaive to chemotherapy, with a Karnofsky score of ≥ 60 Scheduled to receive two courses of moderately emetogenic chemotherapy or cisplatin 60   80 mg/m2 on study Day 1 Use of reliable contraceptive measures (for females of childbearing potential) and negative pregnancy test at baseline visit Patients with hepatic, renal, or cardiovascular impairment eligible at the investigator's discretion Patients experiencing, at maximum, mild nausea after previous chemotherapy eligible at the investigator's discretion Predicted life expectancy of ≥ 3 months Provision of written informed consent. Exclusion Criteria: Inability to understand or cooperate with study procedures Receipt of investigational drugs ≤ 30 days before study entry Receipt of other investigational drugs during the course of this study Seizure disorder or any condition requiring anticonvulsants, sedatives CNS malignancy or metastasis Ongoing emesis due to obstruction of digestive tract Emesis, retching, or Grade 2 or 3 nausea 24 hrs before chemotherapy Moderate or severe nausea and vomiting after any previous chemotherapy Scheduled receipt of any chemotherapeutic agent with an emetogenicity level >3 during study Days 2-5 Scheduled receipt of radiotherapy of the upper abdomen or cranium on study Days 2-5 Scheduled to receive any other drug with potential antiemetic efficacy within 24 h of study initiation and throughout day 5 Contraindications to 5-HT3 receptor antagonists Contraindications to chemotherapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Palonosetron|nan|
|Drug: Granisetron|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Protection from Vomiting (ie.Complete Response in Preventing Vomiting) |  | 0-24h, 24-120h , 0-120h following chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Protection from vomiting |  | 0-24h,24-120h,0-120h following chemotherapy | 
| Major Protection from nausea |  | 0-24h,24-120h,0-120h following chemotherapy | 
| Complete Protection from Both Vomiting and Nausea |  | 0-24h,24-120h,0-120h following chemotherapy | 
| Complete Protection from Both Vomiting and Moderate-to-Severe nausea |  | 0-24h,24-120h,0-120h following chemotherapy | 
| Time to First Emetic Episode |  | 0-120h following chemotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemotherapy-induced nausea and vomiting, acute, delayed, emesis, antiemetics, 5-HT3 receptor antagonist, granisetron, palonosetron