Pharmacokinetics Study of Liposomal Paclitaxel in Humans - Full Text View

Sponsors and Collaborators:	Shandong Luye Pharmaceutical Co., Ltd. Nanjing Sike Pharmaceutical Co., Ltd.
Information provided by:	Shandong Luye Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00606515

Purpose

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.

Condition	Intervention	Phase
Cancer	Drug: Liposomal paclitaxel Drug: Paclitaxel	Phase IV

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study
Official Title:	A Clinical Trial to Compare the Pharmacokinetics of Two Formulations of Taxane, Paclitaxel Injection and Liposomal Paclitaxel, in Humans

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Paclitaxel

U.S. FDA Resources

Further study details as provided by Shandong Luye Pharmaceutical Co., Ltd.:

Primary Outcome Measures:

Pharmacokinetic parameters [ Time Frame: 72 hours after the infusion ] [ Designated as safety issue: No ]

Estimated Enrollment:	16
Study Start Date:	February 2008
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Liposomal paclitaxel	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.
B: Active Comparator Paclitaxel	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.

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606515

Locations

China
Cancer Hospital of Fudan University
Shanghai, China, 200032
Cancer Hospital of Fudan University
Shanghai, China, 200032

Sponsors and Collaborators

Shandong Luye Pharmaceutical Co., Ltd.

Nanjing Sike Pharmaceutical Co., Ltd.

Investigators

Principal Investigator:

Jin Li, Doctor

Cancer Hospital of Fudan University

More Information

No publications provided

Responsible Party:	Cancer Hospital of Fudan University ( Dr. Li Jin )
Study ID Numbers:	LPS-PK-01-2008
Study First Received:	January 21, 2008
Last Updated:	February 9, 2009
ClinicalTrials.gov Identifier:	NCT00606515 History of Changes
Health Authority:	China: Ministry of Health

Keywords provided by Shandong Luye Pharmaceutical Co., Ltd.:

Pharmacokinetics
Liposomal paclitaxel

Study placed in the following topic categories:

Paclitaxel
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Taxane

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Paclitaxel
Therapeutic Uses
Mitosis Modulators

Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 03, 2009