NCT00619021

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	gemcitabine hydrochloride	4 dose levels designated by cohort; 600 mg/m\^2, 800 mg/m\^2, 1000 mg/m\^2, 1200 mg/m\^2

Timeline

• Start date: 2003-01-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2008-02-20
• Last updated: 2017-11-29

Locations

1 site across 1 country: United States