Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005875
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
2000-06-02
Brief Title:
Nitrocamptothecin in Treating Patients With Metastatic Melanoma
Sponsor:
Astex Pharmaceuticals Inc
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Evaluation of RFS 2000 9-Nitro-Camptothecin 9NC in Metastatic Melanoma
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 metastatic melanoma
PURPOSE Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have metastatic melanoma
Detailed Description:
OBJECTIVES I Assess the efficacy and toxicity of nitrocamptothecin in patients with metastatic melanoma
OUTLINE Patients are stratified according to disease choroidal vs nonchoroidal Patients receive oral nitrocamptothecin daily on days 1-5 Treatment continues weekly for at least 8 weeks 2 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 28-74 patients 14-37 per stratum will be accrued for this study
OUTLINE Patients are stratified according to disease choroidal vs nonchoroidal Patients receive oral nitrocamptothecin daily on days 1-5 Treatment continues weekly for at least 8 weeks 2 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 28-74 patients 14-37 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-98237 | None | None | None |
| SUPERGEN-RFS2000-10 | None | None | None |