Pharmacokinetics Study of Liposomal Paclitaxel in Humans (LPS-PK-H)

February 9, 2009 updated by: Shandong Luye Pharmaceutical Co., Ltd.

A Clinical Trial to Compare the Pharmacokinetics of Two Formulations of Taxane, Paclitaxel Injection and Liposomal Paclitaxel, in Humans

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200032
        • Cancer Hospital of Fudan University
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Cancer Hospital of Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Liposomal paclitaxel
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.
Active Comparator: B
Paclitaxel
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic parameters
Time Frame: 72 hours after the infusion
72 hours after the infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Luye Pharmaceutical Co., Ltd.

Collaborators

Nanjing Sike Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Jin Li, Doctor, Cancer Hospital of Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

January 21, 2008

First Submitted That Met QC Criteria

January 31, 2008

First Posted (Estimate)

February 4, 2008

Study Record Updates

Last Update Posted (Estimate)

February 10, 2009

Last Update Submitted That Met QC Criteria

February 9, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LPS-PK-01-2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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