Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006230
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2000-09-11
Brief Title:
Nitrocamptothecin in Treating Patients With Advanced Ovarian 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 Ovarian 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 ovarian cancer
PURPOSE Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have advanced ovarian cancer
Detailed Description:
OBJECTIVES
Determine the objective response rate and duration of response in patients with advanced ovarian cancer treated with nitrocamptothecin
Determine the probability of objective response as expressed by the response rate in patients treated with this regimen
Determine the toxicity 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 PR or CR
Patients are followed every 6 weeks until disease progression or the initiation of another antitumor therapy
PROJECTED ACCRUAL A total of 28-50 patients 14-25 per stratum will be accrued for this study
Determine the objective response rate and duration of response in patients with advanced ovarian cancer treated with nitrocamptothecin
Determine the probability of objective response as expressed by the response rate in patients treated with this regimen
Determine the toxicity 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 PR or CR
Patients are followed every 6 weeks until disease progression or the initiation of another antitumor therapy
PROJECTED ACCRUAL A total of 28-50 patients 14-25 per stratum will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-16996O | None | None | None |