Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020007
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2001-07-11
Brief Title:
Paclitaxel and Hyperthermic Perfusion in Treating Patients With Lung Cancer or Lung Metastases That Cannot Be Removed By Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Isolated Lung Perfusion With Paclitaxel and Moderate Hyperthermia in Patients With Unresectable Pulmonary Malignancies
Status:
COMPLETED
Status Verified Date:
2006-01
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Heating paclitaxel to several degrees above body temperature and infusing it to the affected area around the tumor may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of paclitaxel given by hyperthermic perfusion in treating patients with lung cancer or lung metastases that cannot be removed by surgery
PURPOSE This phase I trial is studying the side effects and best dose of paclitaxel given by hyperthermic perfusion in treating patients with lung cancer or lung metastases that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and phase II dose of paclitaxel administered via hyperthermic retrograde isolated lung perfusion in patients with unresectable pulmonary malignancies
Determine the nature of the toxic effects of this regimen in this patient population
Evaluate the pharmacokinetic profile of this regimen in these patients
Determine the relationship between pharmacodynamic parameters and toxic effects of this regimen in these patients
OUTLINE This is a dose-escalation study of paclitaxel
Patients undergo posterolateral thoracotomy or median sternotomy Patients receive paclitaxel over 90 minutes administered via hyperthermic retrograde isolated lung perfusion The entire surgery lasts approximately 4 hours
Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 1 and 2 months Patients with responding disease continue to be followed every 3 months
PROJECTED ACCRUAL A maximum of 31 patients will be accrued for this study
Determine the maximum tolerated dose and phase II dose of paclitaxel administered via hyperthermic retrograde isolated lung perfusion in patients with unresectable pulmonary malignancies
Determine the nature of the toxic effects of this regimen in this patient population
Evaluate the pharmacokinetic profile of this regimen in these patients
Determine the relationship between pharmacodynamic parameters and toxic effects of this regimen in these patients
OUTLINE This is a dose-escalation study of paclitaxel
Patients undergo posterolateral thoracotomy or median sternotomy Patients receive paclitaxel over 90 minutes administered via hyperthermic retrograde isolated lung perfusion The entire surgery lasts approximately 4 hours
Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 1 and 2 months Patients with responding disease continue to be followed every 3 months
PROJECTED ACCRUAL A maximum of 31 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 |
|---|---|---|---|
| NCI-00-C-0019 | None | None | None |