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Bronchial Artery Infusion of Gemcitabine in Treating Patients With Recurrent or Progressive Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:
A Phase I Study Evaluating Bronchial Artery Infusion (BAI) of Gemcitabine in Recurrent or Progressive Non-Small Cell Lung Cancer

Clinical Trial Summary

RATIONALE: Bronchial artery infusion uses a catheter to deliver antitumor substances directly to the lungs. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving gemcitabine in different ways may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine given by bronchial artery infusion and to see how well it works in treating patients with recurrent or progressive non-small cell lung cancer.

Clinical Trial Description

OBJECTIVES:

Primary

- To establish the maximum tolerated dose of gemcitabine hydrochloride delivered via bronchial artery infusion in patients with recurrent or progressive non-small cell lung cancer.

Secondary

- To evaluate local response in patients treated with this therapy.

- To characterize the pharmacokinetics of gemcitabine hydrochloride in patients treated with this therapy.

OUTLINE: This is a dose-escalation study of gemcitabine hydrochloride delivered via bronchial artery infusion.

Patients receive gemcitabine hydrochloride via bronchial artery infusion over 30-60 minutes on day 1 and via IV infusion over 30 minutes on day 8 of course 1. Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 of all subsequent courses. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.

After completion of study therapy, patients are followed every 8 weeks to 3 months for up to 2 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00619021
Study type Interventional
Source Masonic Cancer Center, University of Minnesota
Contact
Status Terminated
Phase Phase 1
Start date January 2003
Completion date January 2009
View Details
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