|
|
|
|
|
|
Sponsored by: |
National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00020007 |
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.
Condition | Intervention | Phase |
Lung Cancer Metastatic Cancer |
Drug: paclitaxel Procedure: hyperthermia treatment Procedure: isolated perfusion |
Phase I |
MedlinePlus related topics: | Cancer Fever Lung Cancer |
ChemIDplus related topics: | Paclitaxel |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Isolated Lung Perfusion With Paclitaxel and Moderate Hyperthermia in Patients With Unresectable Pulmonary Malignancies |
Study Start Date: | December 1999 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed unresectable primary lung cancer or pulmonary metastases that are unresectable on the basis of technical considerations or are sufficiently numerous that recurrent, potentially inoperable disease is highly probable
No active intracranial or leptomeningeal metastases
Prior resection or radiotherapy for intracranial metastases allowed if the following criteria are met:
Adequate pulmonary reserve to tolerate pneumonectomy:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Maryland | |||||
NCI - Center for Cancer Research | |||||
Bethesda, Maryland, United States, 20892 | |||||
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |||||
Bethesda, Maryland, United States, 20892-1182 |
Study Chair: | David S. Schrump, MD | NCI - Surgery Branch |
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
Study ID Numbers: | CDR0000067490, NCI-00-C-0019 |
First Received: | July 11, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00020007 |
Health Authority: | United States: Federal Government |
|
|
|
|
|
|