Pharmacokinetics Study of Liposomal Paclitaxel in Humans

Cancer Clinical Trial

— LPS-PK-H  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00606515
• Other study ID #: LPS-PK-01-2008
• Status: Completed
• Phase: Phase 4
• First received: January 21, 2008
• Last updated: February 9, 2009
• Start date: February 2008
• Est. completion date: October 2008

Study information

• Verified date: February 2009
• Source: Shandong Luye Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Cancer Hospital of Fudan University	Shanghai	Shanghai
China	Cancer Hospital of Fudan University	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shandong Luye Pharmaceutical Co., Ltd.	Nanjing Sike Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameters		72 hours after the infusion