Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082706
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2004-05-14
Brief Title:
Fluorouracil Leucovorin Gemcitabine and Cisplatin in Treating Patients With Metastatic or Unresectable Adenocarcinoma of the Urothelium or Urachal Remnant
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Trial of 5-FU Leucovorin Gemcitabine and Cisplatin for Adenocarcinomas of the Urothelial Tract and Urachal Remnant
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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 such as fluorouracil leucovorin gemcitabine and cisplatin work in different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE This phase II trial is studying how well giving fluorouracil together with leucovorin gemcitabine and cisplatin works in treating patients with metastatic or unresectable adenocarcinoma of the urothelium or urachal remnant part of the bladder
PURPOSE This phase II trial is studying how well giving fluorouracil together with leucovorin gemcitabine and cisplatin works in treating patients with metastatic or unresectable adenocarcinoma of the urothelium or urachal remnant part of the bladder
Detailed Description:
OBJECTIVES
Primary
Determine the response rate and overall survival of patients with metastatic or unresectable adenocarcinoma of the urothelium or urachal remnant treated with fluorouracil leucovorin calcium gemcitabine and cisplatin
Secondary
Determine the toxicity of this regimen in these patients
OUTLINE Patients are stratified according to diagnosis adenocarcinoma of the urothelium vs adenocarcinoma of the urachal remnant
Patients receive fluorouracil by vein IV continuously leucovorin calcium IV once daily and cisplatin IV once daily on days 1-5 and gemcitabine IV on days 1 and 5 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3-6 months
PROJECTED ACCRUAL A total of 23-46 patients 7-18 with adenocarcinoma of the urachal remnant and 16-28 with adenocarcinoma of the urothelium will be accrued for this study
Primary
Determine the response rate and overall survival of patients with metastatic or unresectable adenocarcinoma of the urothelium or urachal remnant treated with fluorouracil leucovorin calcium gemcitabine and cisplatin
Secondary
Determine the toxicity of this regimen in these patients
OUTLINE Patients are stratified according to diagnosis adenocarcinoma of the urothelium vs adenocarcinoma of the urachal remnant
Patients receive fluorouracil by vein IV continuously leucovorin calcium IV once daily and cisplatin IV once daily on days 1-5 and gemcitabine IV on days 1 and 5 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3-6 months
PROJECTED ACCRUAL A total of 23-46 patients 7-18 with adenocarcinoma of the urachal remnant and 16-28 with adenocarcinoma of the urothelium will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| P50CA091846 | NIH | None | None |
| ID-030111 | OTHER | None | None |
| CDR0000355828 | REGISTRY | None | None |
| NCI-2012-01305 | REGISTRY | NCI CTRP | httpsreporternihgovquickSearchP50CA091846 |