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

Luye Pharma Group

Status and phase

Completed

Phase 4

Conditions

Cancer

Treatments

Drug: Paclitaxel

Drug: Liposomal paclitaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00606515

LPS-PK-01-2008

Details and patient eligibility

About

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 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.

Enrollment

16 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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