Pharmacokinetics Study of Liposomal Paclitaxel in Humans

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00606515

Acronym

LPS-PK-H

Enrollment

Registered

2008-02-04

Start date

2008-02-29

Completion date

2008-10-31

Last updated

2009-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Pharmacokinetics, Liposomal paclitaxel

Brief summary

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.

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

DRUGLiposomal 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.

DRUGPaclitaxel

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic parameters	72 hours after the infusion

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026