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A Clinical Trial to Compare the Pharmacokinetics of Two Formulations of Taxane, Paclitaxel Injection and Liposomal Paclitaxel, in Humans


Phase 4
18 Years
75 Years
Not Enrolling
Both
Cancer

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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

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