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

This study has been completed.
Sponsor:
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT00666783
First received: April 23, 2008
Last updated: April 24, 2008
Last verified: August 2006
History of Changes
  Purpose

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.


Condition Intervention Phase
Chemotherapy-Induced Nausea and Vomiting
 Drug: palonosetron
Drug: Granisetron
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Xijing Hospital:

Enrollment: 208
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00666783

Locations
China, Shaanxi
Xijng Hospital
Xi,an, Shaanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital
  More Information

No publications provided

Responsible Party: Xijing Hospital, Clinical trial center of Xijing Hospital
ClinicalTrials.gov Identifier: NCT00666783     History of Changes
Other Study ID Numbers: 2006L01595
Study First Received: April 23, 2008
Last Updated: April 24, 2008
Health Authority: China: the State Food and Drug Administration

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Granisetron
Palonosetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013