Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006026
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2000-07-05
Brief Title:
Nitrocamptothecin in Treating Patients With Metastatic Cancer of the Urinary Tract
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 AdvancedMetastatic Urothelial Tract Tumors
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 metastatic cancer of the urinary tract
PURPOSE Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have metastatic cancer of the urinary tract
Detailed Description:
OBJECTIVES I Determine the objective response to nitrocamptothecin in patients with metastatic urothelial tract tumors II Determine the response rate in these patients when treated with this regimen III Determine the duration of objective response in these patients when treated with this regimen IV Characterize the toxicities of this treatment in this patient population
OUTLINE This is a multicenter study Patients receive oral nitrocamptothecin daily on days 1-5 Treatment continues weekly every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 6 weeks until disease progression
PROJECTED ACCRUAL A total of 14-25 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive oral nitrocamptothecin daily on days 1-5 Treatment continues weekly every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 6 weeks until disease progression
PROJECTED ACCRUAL A total of 14-25 patients will be accrued for this study
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-16996U | None | None | None |