Surgery and Intrapleural Docetaxel in Treating Patients With Malignant Pleural Effusion
RATIONALE: Giving drugs, such as docetaxel, directly into the pleura after surgery to drain the pleural effusion may help keep fluid from building up again.
PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of intrapleural docetaxel given after surgery in patients with malignant pleural effusion.
Procedure: therapeutic thoracoscopy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Trial of Intrapleural Docetaxel Administered Via an Implantable Catheter in Subjects With a Malignant Pleural Effusion|
- Maximum tolerated dose by adverse event evaluation 1 month after treatment [ Designated as safety issue: Yes ]
- Pharmacokinetics by serum and pleural fluid analyses through 1 month [ Designated as safety issue: No ]
- Clinical response by chest x-ray response and survival [ Designated as safety issue: No ]
|Study Start Date:||July 2003|
- 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 patients.
- 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 thereafter.
PROJECTED ACCRUAL: Approximately 8-24 patients will be accrued for this study.
|United States, Virginia|
|University of Virginia Cancer Center|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||David R. Jones, MD||University of Virginia|