Pharmacokinetics Study of Liposomal Paclitaxel in Humans

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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A

Liposomal paclitaxel

Group Type EXPERIMENTAL

Liposomal paclitaxel

Intervention Type DRUG

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.

B

Paclitaxel

Group Type ACTIVE_COMPARATOR

Paclitaxel

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No