Phase I Trial of Intrapleural Docetaxel Administered Via an Implantable Catheter in Subjects With a Malignant Pleural Effusion
- Determine the maximum tolerated dose of intrapleural docetaxel in patients with
malignant pleural effusion.
- Determine the toxicity profile of this drug in these patients.
- Determine the pharmacokinetics of this drug in plasma and pleural fluid from these
- Determine the response in patients treated with this drug.
OUTLINE: This is a dose-escalation study.
Patients undergo thorascopic surgery to drain the malignant pleural effusion. An
intrapleural catheter (Pleurx catheter) is then inserted for subsequent docetaxel
instillation. Approximately 24 hours after surgery, patients receive docetaxel
intrapleurally over 3 minutes via the Pleurx catheter. The Pleurx catheter is then clamped
for 4 hours and the patient is placed in several different positions to ensure uniform
distribution of docetaxel throughout the pleural cavity.
Cohorts of 3-6 patients receive escalating doses of intrapleural docetaxel until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed at weeks 1 and 3 and then monthly
PROJECTED ACCRUAL: Approximately 8-24 patients will be accrued for this study.
Primary Purpose: Treatment
Maximum tolerated dose by adverse event evaluation 1 month after treatment
David R. Jones, MD
University of Virginia
United States: Federal Government
|University of Virginia Cancer Center||Charlottesville, Virginia 22908|