Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009867
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2001-02-02
Brief Title:
Arsenic Trioxide in Treating Patients With Urothelial Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A PHASE II STUDY OF ARSENIC TRIOXIDE NSC 706363 IND 57974 IN UROTHELIAL CANCER
Status:
COMPLETED
Status Verified Date:
2013-06
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:
Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have recurrent cancer of the bladder or urinary tract Arsenic trioxide may kill tumor cells that have become resistant to standard chemotherapy regimens
Detailed Description:
PRIMARY OBJECTIVES
I To determine the efficacy of arsenic trioxide in patients with measurable urothelial carcinoma of the bladder urethra ureter or renal pelvis
II To determine the toxicity of arsenic trioxide administered to patients with urothelial cancer
OUTLINE
Patients receive arsenic trioxide IV over 1 hour on days 1-5 Treatment repeats every 28 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity Patients who achieve complete response receive 2 additional courses
Patients are followed every 2 months for 1 year after registration and then every 6 months for 1 year or until disease progression or relapse
I To determine the efficacy of arsenic trioxide in patients with measurable urothelial carcinoma of the bladder urethra ureter or renal pelvis
II To determine the toxicity of arsenic trioxide administered to patients with urothelial cancer
OUTLINE
Patients receive arsenic trioxide IV over 1 hour on days 1-5 Treatment repeats every 28 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity Patients who achieve complete response receive 2 additional courses
Patients are followed every 2 months for 1 year after registration and then every 6 months for 1 year or until disease progression or relapse
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 |
|---|---|---|---|
| U10CA031946 | NIH | None | httpsreporternihgovquickSearchU10CA031946 |
| CALGB-99903 | None | None | None |