Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114205
Status:
COMPLETED
Last Update Posted:
2010-03-18
First Post:
2005-06-13
Brief Title:
Surgery and Intrapleural Docetaxel in Treating Patients With Malignant Pleural Effusion
Sponsor:
University of Virginia
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Trial of Intrapleural Docetaxel Administered Via an Implantable Catheter in Subjects With a Malignant Pleural Effusion
Status:
COMPLETED
Status Verified Date:
2006-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UVACC-29303 | None | None | None |
| UVACC-HIC-10722 | None | None | None |