Open Label Phase II Study on RFS 2000 (9-Nitro-Camptothecin, 9-NC) Administered as a "5 Days On - 2 Days Off" Oral Treatment in Advanced Small Cell Lung Cancer
- Determine the objective response and duration of objective response in patients with
advanced small cell lung cancer treated with nitrocamptothecin.
- Determine the probability of objective response as expressed by the response rate in
patients treated with this regimen.
- Determine the toxicities of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to disease status
(sensitive vs refractory).
Patients receive oral nitrocamptothecin daily for 5 consecutive days each week for 3 weeks.
Treatment continues every 3 weeks for a minimum of 2 courses in the absence of disease
progression or unacceptable toxicity. Patients who achieve stable disease (SD) receive up to
4 additional courses past SD. Patients who achieve partial response (PR) or complete
response (CR) receive a minimum of 2 additional courses past CR or PR.
Patients are followed every 6 weeks until disease progression or initiation of another
PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for the sensitive disease
stratum and a total of 19-24 patients will be accrued for the refractory disease stratum
Primary Purpose: Treatment
Pierre Fumoleau, MD, PhD
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
United States: Federal Government