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Pharmacokinetics Study of Liposomal Paclitaxel in Humans (LPS-PK-H)

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ClinicalTrials.gov Identifier: NCT00606515
Recruitment Status : Completed
First Posted : February 4, 2008
Last Update Posted : February 10, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Cancer Drug: Liposomal paclitaxel Drug: Paclitaxel Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Clinical Trial to Compare the Pharmacokinetics of Two Formulations of Taxane, Paclitaxel Injection and Liposomal Paclitaxel, in Humans
Study Start Date : February 2008
Primary Completion Date : October 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A
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.
Active Comparator: B
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.


Outcome Measures

Primary Outcome Measures :
  1. Pharmacokinetic parameters [ Time Frame: 72 hours after the infusion ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606515


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

Responsible Party: Dr. Li Jin, Cancer Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT00606515     History of Changes
Other Study ID Numbers: LPS-PK-01-2008
First Posted: February 4, 2008    Key Record Dates
Last Update Posted: February 10, 2009
Last Verified: February 2009

Keywords provided by Shandong Luye Pharmaceutical Co., Ltd.:
Pharmacokinetics
Liposomal paclitaxel

Additional relevant MeSH terms:
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action