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

April 24, 2008 updated by: Xijing Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi,an, Shaanxi, China, 710032
        • Xijng Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 23, 2008

First Submitted That Met QC Criteria

April 24, 2008

First Posted (Estimate)

April 25, 2008

Study Record Updates

Last Update Posted (Estimate)

April 25, 2008

Last Update Submitted That Met QC Criteria

April 24, 2008

Last Verified

August 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006L01595

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe