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NCT Number: NCT00606515

Pharmacokinetics Study of Liposomal Paclitaxel in Humans

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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Key information

Conditions

Cancer Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cancer Hospital of Fudan University, Shanghai, Shanghai Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liposomal Paclitaxel

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.

paclitaxel

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.

Primary outcomes

  1. Pharmacokinetic parameters

    Time frame: 72 hours after the infusion

Sponsors and collaborators

Lead sponsor

Shandong Luye Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Nanjing Sike Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Acronym: LPS-PK-H

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 4, 2008
Registry last updated
Feb 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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