An Efficacy and Safety Study of Palonosetron in Preventing Chemotherapy-Induced Nausea and Vomiting (CINV) in the Chinese Cancer Patients

Study Overview
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Brief Summary
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This clinical study was designed to demonstrate that a single, intravenous dose of palonosetron 0.25 mg was not inferior to granisetron 3 mg in preventing acute and delayed CINV and was also well tolerated in the Chinese cancer patients.

Official Title
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A Phase II, Multicenter,Double-Blind, Randomized Trial of Palonosetron Compared With Granisetron in Preventing Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting in the Chinese Cancer Patients

Conditions
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Chemotherapy-Induced Nausea and Vomiting

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 ranging from 18 yrs to 70 yrs, with histologically or cytologically confirmed malignant disease naive to chemotherapy or nonnaive with an interval of at least 14 days to the last one Karnofsky index more than 70% and anticipated survival time more than 90 days Scheduled to receive any of the following cytotoxic agents based combination chemotherapy (epirubicin 60 mg/m2, or cisplatin 75 mg/m2) on study Day 1 and the chemotherapy should be accomplished on study Day 1 No emetic episodes and antiemetic medication during the 24 hours preceding chemotherapy administration Adequate organ functions(No impairment to renal, hepatic, cardiac or bone marrow function ) Use of reliable contraceptive measures (for females of childbearing potential) and negative pregnancy test at baseline visit Provision of written informed consent Exclusion Criteria: Inability to understand or cooperate with study procedures Receipt of investigational drugs 30 days before study entry Scheduled to receive any drug with antiemetic efficacy from 24 hrs before to 5 days after treatment Contraindications to 5-HT3 receptor antagonists Woman Patient with Pregnancy or lactation Diagnosed with hypertension or severe infectious diseases Obstructive symptom of gastrointestinal tract Symptomatic brain metastasis or mental dysfunction Baseline QTc > 500 ms

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAL<br>receive any of the following cytotoxic agents based combination chemotherapy (epirubicin 60 mg/m2, or cisplatin 75 mg/m2) | Drug: palonosetron<br>* receive a single, intravenous dose of palonosetron 0.25 mg, 30 minutes before receiving highly emetogenic chemotherapy.<br>|
| Active Comparator: GRA<br>receive any of the following cytotoxic agents based combination chemotherapy (epirubicin 60 mg/m2, or cisplatin 75 mg/m2) | Drug: Granisetron<br>* receive a single, intravenous dose of granisetron 3 mg, 30 minutes before chemotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |