A Phase I Study Evaluating Bronchial Artery Infusion (BAI) of Gemcitabine in Recurrent or Progressive Non-Small Cell Lung Cancer
- To establish the maximum tolerated dose of gemcitabine hydrochloride delivered via
bronchial artery infusion in patients with recurrent or progressive non-small cell lung
- 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
After completion of study therapy, patients are followed every 8 weeks to 3 months for up to
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose and dose-limiting toxicity of gemcitabine hydrochloride when administered via bronchial artery infusion
At time of dose-limiting toxicity
Jonathan D'Cunha, MD, PhD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|Masonic Cancer Center at University of Minnesota||Minneapolis, Minnesota 55455|