Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006082
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2000-08-03
Brief Title:
Nitrocamptothecin in Treating Patients With Advanced Small Cell Lung Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
PURPOSE Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have advanced small cell lung cancer
Detailed Description:
OBJECTIVES
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-16996SL | None | None | None |