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

Chemotherapy-Induced Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00666783
• Other study ID #: 2006L01595
• Status: Completed
• Phase: Phase 2
• First received: April 23, 2008
• Last updated: April 24, 2008

Study information

• Verified date: August 2006
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: the State Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chemotherapy-Induced Nausea and Vomiting
• Nausea
• Vomiting

Intervention

Drug:
• palonosetron
receive a single, intravenous dose of palonosetron 0.25 mg, 30 minutes before receiving highly emetogenic chemotherapy.
• Granisetron
receive a single, intravenous dose of granisetron 3 mg, 30 minutes before chemotherapy.

Locations

Country	Name	City	State
China	Xijng Hospital	Xi,an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China,