Nitrocamptothecin in Treating Patients With Advanced Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00006082|
Recruitment Status : Completed
First Posted : May 22, 2003
Last Update Posted : September 24, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: rubitecan||Phase 2|
- 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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|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|
|Actual Primary Completion Date :||August 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006082
|CRLCC Nantes - Atlantique|
|Nantes-Saint Herblain, France, 44805|
|Study Chair:||Pierre Fumoleau, MD, PhD||Centre Georges Francois Leclerc|