Pharmacokinetics Study of Liposomal Paclitaxel in Humans
LPS-PK-H
A Clinical Trial to Compare the Pharmacokinetics of Two Formulations of Taxane, Paclitaxel Injection and Liposomal Paclitaxel, in Humans
1 other identifier
interventional
16
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 cancer
Started Feb 2008
Shorter than P25 for phase_4 cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2008
CompletedStudy Start
First participant enrolled
February 1, 2008
CompletedFirst Posted
Study publicly available on registry
February 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedFebruary 10, 2009
February 1, 2009
8 months
January 21, 2008
February 9, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetic parameters
72 hours after the infusion
Study Arms (2)
A
EXPERIMENTALLiposomal paclitaxel
B
ACTIVE COMPARATORPaclitaxel
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Cancer Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032, China
Cancer Hospital of Fudan University
Shanghai, 200032, China
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jin Li, Doctor
Cancer Hospital of Fudan University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 21, 2008
First Posted
February 4, 2008
Study Start
February 1, 2008
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
February 10, 2009
Record last verified: 2009-02