Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005874
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
2000-06-02
Brief Title:
Nitrocamptothecin in Treating Patients With Soft Tissue Sarcomas
Sponsor:
Astex Pharmaceuticals Inc
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of RFS 2000 9-Nitro-Camptothecin 9-NC in Patients With Soft-Tissue Sarcomas
Status:
COMPLETED
Status Verified Date:
2001-09
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 locally advanced or metastatic soft tissue sarcomas
PURPOSE Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have locally advanced or metastatic soft tissue sarcomas
Detailed Description:
OBJECTIVES I Assess the efficacy and toxicity of nitrocamptothecin in patients with locally advanced or metastatic gastrointestinal leiomyosarcomas or other soft tissue sarcomas
OUTLINE Patients are stratified by disease gastrointestinal leiomyosarcomas vs other soft tissue sarcomas Patients receive oral nitrocamptothecin daily on days 1-5 Treatment continues weekly in the absence of disease progression or unacceptable toxicity Responding patients who undergo surgery then receive an additional 4-6 courses 4 weekscourse
PROJECTED ACCRUAL A total of 34-78 patients 17-39 per stratum will be accrued for this study
OUTLINE Patients are stratified by disease gastrointestinal leiomyosarcomas vs other soft tissue sarcomas Patients receive oral nitrocamptothecin daily on days 1-5 Treatment continues weekly in the absence of disease progression or unacceptable toxicity Responding patients who undergo surgery then receive an additional 4-6 courses 4 weekscourse
PROJECTED ACCRUAL A total of 34-78 patients 17-39 per stratum 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 |
|---|---|---|---|
| MDA-DM-99109 | None | None | None |
| SUPERGEN-RFS2000-24 | None | None | None |