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

Shandong Luye Pharmaceutical Co., Ltd.1 site in 1 country16 target enrollmentFebruary 2008

ConditionsCancer

InterventionsLiposomal paclitaxel Paclitaxel

DrugsLiposomal paclitaxel Paclitaxel

Overview

Phase: Phase 4
Intervention: Liposomal paclitaxel
Conditions: Cancer
Sponsor: Shandong Luye Pharmaceutical Co., Ltd.
Enrollment: 16
Locations: 1
Primary Endpoint: Pharmacokinetic parameters
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2008

End Date

October 2008

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shandong Luye Pharmaceutical Co., Ltd.

Eligibility Criteria

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