Phase II Study of Aerosolized Liposomal 9-Nitro-20 (S)- Camptothecin (L9NC)
This is a single-arm, non-randomized Phase II trial of DLPC-9NC administered by aerosol 5
consecutive days per week for 8 weeks every 10 weeks.
Dose: 0.4 mg/ml of 9-NC in aerosol reservoir for 60 minutes (= daily dose of 0.52 mg/m2/day)
per day X5 every week, X8 weeks, then observe for 2 weeks. One course = 10 weeks.
Patients that have a resectable lung cancer will only receive one course of treatment and
will be operated on about two weeks after completing the 8-week course.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the overall response rate to liposomal 9-Nitro-20 (S)-Camptothecin (L9NC) administered by aerosolization in patients with non-small-cell lung cancer (any stage).
disease progression or unacceptable toxicities
Claire F Verschraegen, MD
University of New Mexico
United States: Food and Drug Administration
|University of New Mexico||Albuquerque, New Mexico 87131|