A Phase I Study of Isolated Lung Perfusion With Paclitaxel and Moderate Hyperthermia in Patients With Unresectable Pulmonary Malignancies
- Determine the maximum tolerated dose and phase II dose of paclitaxel administered via
hyperthermic retrograde isolated lung perfusion in patients with unresectable pulmonary
- 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.
Primary Purpose: Treatment
David S. Schrump, MD
NCI - Surgery Branch
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|
|NCI - Center for Cancer Research||Bethesda, Maryland 20892|