Metastatic Cancer Clinical Trial
Official title:
Phase I Trial of Intrapleural Docetaxel Administered Via an Implantable Catheter in Subjects With a 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.
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of intrapleural docetaxel in patients with
malignant pleural effusion.
Secondary
- 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.
;
Primary Purpose: Treatment
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