Nitrocamptothecin in Treating Patients With Advanced Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have advanced small cell lung cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
|Study Start Date:||May 2000|
|Primary Completion Date:||August 2002 (Final data collection date for primary outcome measure)|
- 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 antitumor treatment.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006082
|CRLCC Nantes - Atlantique|
|Nantes-Saint Herblain, France, 44805|
|Study Chair:||Pierre Fumoleau, MD, PhD||Centre Georges Francois Leclerc|