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NCT Number: NCT00666783

An Efficacy and Safety Study of Palonosetron in Preventing Chemotherapy-Induced Nausea and Vomiting (CINV) 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.

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Key information

Conditions

Chemotherapy-induced Nausea and Vomiting Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Xijng Hospital

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Palonosetron

Drug

receive a single, intravenous dose of palonosetron 0.25 mg, 30 minutes before receiving highly emetogenic chemotherapy.

Granisetron

Drug

receive a single, intravenous dose of granisetron 3 mg, 30 minutes before chemotherapy.

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study 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

Important dates

First posted
Apr 25, 2008
Registry last updated
Apr 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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