Pharmacokinetics Study of Liposomal Paclitaxel in Humans

Overview

The purpose of this study is to determine whether there is any difference of the pharmacokinetics of two taxane formulations, paclitaxel injection and liposomal paclitaxel in Chinese cancer patients with solid tumors.

Full Title of Study: “A Clinical Trial to Compare the Pharmacokinetics of Two Formulations of Taxane, Paclitaxel Injection and Liposomal Paclitaxel, in Humans”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2008

Detailed Description

The pharmacokinetics of a new formulation of taxane (liposomal paclitaxel) has never been studied in Chinese cancer patients. This clinical trial is designed to find out the pharmacokinetics of liposomal paclitaxel at the dose of 175mg/m2 and whether it has a different pharmacokinetic profile to paclitaxel.

Interventions

  • Drug: Liposomal paclitaxel
    • Patients will be given Liposomal paclitaxel intravenously in 3 hours with the dose of 175mg/m2 at the first day of chemotherapy. Cycle duration will be 21 days. Each patient will receive 3 cycles of therapy.
  • Drug: Paclitaxel
    • Patients will be given paclitaxel intravenously in 3 hours with the dose of 175mg/m2 at the first day of chemotherapy. Cycle duration will be 21 days. Each patient will receive 3 cycles of therapy.

Arms, Groups and Cohorts

  • Experimental: A
    • Liposomal paclitaxel
  • Active Comparator: B
    • Paclitaxel

Clinical Trial Outcome Measures

Primary Measures

  • Pharmacokinetic parameters
    • Time Frame: 72 hours after the infusion

Participating in This Clinical Trial

Inclusion Criteria

  • Eligible patients must have histologically confirmed solid tumors of advanced stages – Patients who are suitable for being treated with liposomal paclitaxel only – Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 – Patients who are expected to be alive for at least 3 months – Adequate hematologic, hepatic and renal functions – Adequate other organ functions as defined by the protocol – No prior systemic chemotherapy at least 4 weeks before the recruitment – No previous anaphylactic reaction to hormone. Exclusion Criteria:

  • Allergy to any study medication – Serious complication that would compromise the patient's ability to complete the study – Grade ≥1 neuropathy using NCI CTCAE version 3.0 criteria – Pregnancy or breast feeding

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shandong Luye Pharmaceutical Co., Ltd.
  • Collaborator
    • Nanjing Sike Pharmaceutical Co., Ltd.
  • Provider of Information About this Clinical Study
    • Dr. Li Jin, Cancer Hospital of Fudan University
  • Overall Official(s)
    • Jin Li, Doctor, Principal Investigator, Cancer Hospital of Fudan University

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