Trial | NCT00606515  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    paclitaxel ...

  • Study Participants

    16
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.
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.
Study Started
Feb 29
2008
Primary Completion
Oct 31
2008
Study Completion
Oct 31
2008
Last Update
Feb 10
2009
Estimate

Drug 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.

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.

A Experimental

Liposomal paclitaxel

B Active Comparator

Paclitaxel

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
No Results Posted