Surgery and Intrapleural Docetaxel in Treating Patients With Malignant Pleural Effusion

Phase 1

Completed

• Conditions: Metastatic Cancer

• Registration Number: NCT00114205
• Lead Sponsor: University of Virginia

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2005-06-13
• Study First Submitted QC: 2005-06-13
• Study First Posted: 2005-06-14
• Status Verified: 2006-08
• Last Update Submitted: 2010-03-17
• Last Update Posted: 2010-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose by adverse event evaluation 1 month after treatment

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics by serum and pleural fluid analyses through 1 month
Clinical response by chest x-ray response and survival

Trial Locations

Locations (1)

University of Virginia Cancer Center; 🇺🇸 Charlottesville, Virginia, United States