Safety and Efficacy of Palonosetron in Preventing Chemotherapy-induced Nausea and Vomiting

Overview

The purpose of this study is to determine whether palonosetron is tolerate and effective in preventing chemotherapy-induced nausea and vomiting in oriental population. The study is comparing the safety and efficacy of palonosetron with granisetron, a frequently used antiemetic in China.

Full Title of Study: “A Phase II,Multicenter,Randomized,Double-blind,Cross-over Study of Palonosetron Compared With Granisetron in Prevention of Chemotherapy-induced Nausea and Vomiting in Asian Population”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Supportive Care
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 2006

Interventions

  • Drug: Palonosetron
  • Drug: Granisetron

Clinical Trial Outcome Measures

Primary Measures

  • Complete Protection from Vomiting (ie.Complete Response in Preventing Vomiting)
    • Time Frame: 0-24h, 24-120h , 0-120h following chemotherapy

Secondary Measures

  • Major Protection from vomiting
    • Time Frame: 0-24h,24-120h,0-120h following chemotherapy
  • Major Protection from nausea
    • Time Frame: 0-24h,24-120h,0-120h following chemotherapy
  • Complete Protection from Both Vomiting and Nausea
    • Time Frame: 0-24h,24-120h,0-120h following chemotherapy
  • Complete Protection from Both Vomiting and Moderate-to-Severe nausea
    • Time Frame: 0-24h,24-120h,0-120h following chemotherapy
  • Time to First Emetic Episode
    • Time Frame: 0-120h following chemotherapy

Participating in This Clinical Trial

Inclusion Criteria

  • Male or female, age ≥ 18 yrs and <70 yrs with histologically or cytologically confirmed – Malignant disease – Naive or nonnaive to chemotherapy, with a Karnofsky score of ≥ 60 – Scheduled to receive two courses of moderately emetogenic chemotherapy or cisplatin 60 ~ 80 mg/m2 on study Day 1 – Use of reliable contraceptive measures (for females of childbearing potential) and negative pregnancy test at baseline visit – Patients with hepatic, renal, or cardiovascular impairment eligible at the investigator's discretion – Patients experiencing, at maximum, mild nausea after previous chemotherapy eligible at the investigator's discretion – Predicted life expectancy of ≥ 3 months – Provision of written informed consent. Exclusion Criteria:

  • Inability to understand or cooperate with study procedures – Receipt of investigational drugs ≤ 30 days before study entry – Receipt of other investigational drugs during the course of this study – Seizure disorder or any condition requiring anticonvulsants, sedatives – CNS malignancy or metastasis – Ongoing emesis due to obstruction of digestive tract – Emesis, retching, or Grade 2 or 3 nausea 24 hrs before chemotherapy – Moderate or severe nausea and vomiting after any previous chemotherapy – Scheduled receipt of any chemotherapeutic agent with an emetogenicity level >3 during study Days 2-5 – Scheduled receipt of radiotherapy of the upper abdomen or cranium on study Days 2-5 – Scheduled to receive any other drug with potential antiemetic efficacy within 24 h of study initiation and throughout day 5 – Contraindications to 5-HT3 receptor antagonists – Contraindications to chemotherapy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
  • Collaborator
    • Sun Yat-sen University
  • Overall Official(s)
    • Tongyu Lin, M.D., Principal Investigator, Sun Yat-sen University

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