Phase II Study of Irinotecan Followed by Gemcitabine in NSCLC Following Failure of Platinum Based Therapy
- Determine the objective response rate (complete and partial response) in patients with
recurrent or progressive stage IIIA-IV non-small cell lung cancer treated with
irinotecan and gemcitabine.
- Determine the median time to progression in patients treated with this regimen.
OUTLINE: This a non-randomized, open-label, multicenter study.
Patients receive irinotecan IV over 90 minutes on days 1 and 8 and gemcitabine IV over 30
minutes on days 2 and 9. Courses repeat every 21 days in the absence of disease progression
or unacceptable toxicity.
After completion of study treatment, patients are followed for 1 month and then every 8
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 16 months.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response (complete, partial, and stable disease)
Nithya Ramnath, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|