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

This study has been completed.
Sponsor:
Collaborator:
Nanjing Sike Pharmaceutical Co., Ltd.
Information provided by:
Shandong Luye Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00606515
First received: January 21, 2008
Last updated: February 9, 2009
Last verified: February 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
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:


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
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Study First Received: January 21, 2008
Last Updated: February 9, 2009
Health Authority: China: Ministry of Health

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

Additional relevant MeSH terms:
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014