Trial Information
A Clinical Trial to Compare the Pharmacokinetics of Two Formulations of Taxane, Paclitaxel Injection and Liposomal Paclitaxel, in Humans
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label
Outcome Measure:
Pharmacokinetic parameters
Outcome Time Frame:
72 hours after the infusion
Safety Issue:
No
Principal Investigator
Jin Li, Doctor
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cancer Hospital of Fudan University
Authority:
China: Ministry of Health
Study ID:
LPS-PK-01-2008
NCT ID:
NCT00606515
Start Date:
February 2008
Completion Date:
October 2008
Related Keywords:
- Cancer
- Pharmacokinetics
- Liposomal paclitaxel