Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002914
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
1999-11-01
Brief Title:
Piritrexim in Treating Patients With Advanced Cancer of the Urinary Tract
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
PHASE II STUDY OF PIRITREXIM IN ADVANCED CARCINOMA OF THE UROTHELIUM
Status:
COMPLETED
Status Verified Date:
2023-06
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:
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 piritrexim in treating patients with advanced cancer of the urinary tract that has not responded to previous treatment
PURPOSE Phase II trial to study the effectiveness of piritrexim in treating patients with advanced cancer of the urinary tract that has not responded to previous treatment
Detailed Description:
OBJECTIVES I Evaluate the antineoplastic activity of piritrexim and its effect on the survival of patients with advanced urothelial carcinoma previously treated with systemic cytotoxic chemotherapy II Evaluate the toxicity of piritrexim in these patients
OUTLINE Patients receive piritrexim by mouth 3 times daily 5 days a week for 3 weeks followed by 1 week of rest Patients with responding or stable disease continue treatment every 4 weeks until unacceptable toxicity or progression intervenes
PROJECTED ACCRUAL A maximum of 40 patients will be entered over 5-6 months if at least 1 response is observed in the first 14 evaluable patients
OUTLINE Patients receive piritrexim by mouth 3 times daily 5 days a week for 3 weeks followed by 1 week of rest Patients with responding or stable disease continue treatment every 4 weeks until unacceptable toxicity or progression intervenes
PROJECTED ACCRUAL A maximum of 40 patients will be entered over 5-6 months if at least 1 response is observed in the first 14 evaluable patients
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 |
|---|---|---|---|
| E-3896 | None | None | None |