Pharmacokinetics Study of Liposomal Paclitaxel in Humans

Study Overview
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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.

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.

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

Conditions
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Cancer

Intervention / Treatment
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* Drug: Liposomal paclitaxel
* Drug: Paclitaxel


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Liposomal paclitaxel | Drug: Liposomal paclitaxel<br>* 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.<br>|
| Active Comparator: B<br>Paclitaxel | Drug: Paclitaxel<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters |  | 72 hours after the infusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Liposomal paclitaxel