Ignite Creation Date:
2025-12-24 @ 1:43 PM
Ignite Modification Date:
2026-01-01 @ 8:07 AM
Study NCT ID:
NCT00080795
Status:
COMPLETED
Last Update Posted:
2012-10-22
First Post:
2004-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Ifosfamide, Doxorubicin, Gemcitabine, and Cisplatin in Treating Patients Who Are Undergoing Radical Cystectomy for Locally Advanced Carcinoma (Cancer) of the Urothelium
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Phase II Trial of Neoadjuvant, Multi-Agent Chemotherapy For Locally Advanced Urothelial Cancer
Status:
COMPLETED
Status Verified Date:
2012-10
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 ifosfamide, doxorubicin, gemcitabine, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them before surgery, may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well neoadjuvant combination chemotherapy works in treating patients undergoing radical cystectomy for locally advanced carcinoma of the urothelium.
PURPOSE: This phase II trial is studying how well neoadjuvant combination chemotherapy works in treating patients undergoing radical cystectomy for locally advanced carcinoma of the urothelium.
Detailed Description:
OBJECTIVES:
Primary
* Determine the response rate and 4-year disease-free survival of patients with locally advanced carcinoma of the urothelium undergoing radical cystectomy treated with neoadjuvant chemotherapy comprising ifosfamide, doxorubicin, and gemcitabine followed by cisplatin, gemcitabine, and ifosfamide.
Secondary
* Compare perioperative morbidity and mortality of patients treated with this regimen vs historical standards.
OUTLINE: Patients receive neoadjuvant chemotherapy comprising ifosfamide IV over 3 hours on days 1-4, doxorubicin IV on day 3, gemcitabine IV over 30 minutes on days 2 and 4, and filgrastim (G-CSF) subcutaneously on days 7-12 or until blood counts recover. Treatment repeats every 3 weeks for a total of 3 courses. Patients then receive cisplatin IV, gemcitabine IV over 90 minutes, and ifosfamide IV over 30 minutes on day 1. Treatment repeats every 2 weeks for a total of 4-6 courses. Four to six weeks after the completion of all neoadjuvant chemotherapy, patients undergo cystectomy.
Patients are followed at 9, 12, 15, 18, 24, and 30 months and then annually thereafter.
PROJECTED ACCRUAL: A total of 31-49 patients will be accrued for this study within 16-25 months.
Primary
* Determine the response rate and 4-year disease-free survival of patients with locally advanced carcinoma of the urothelium undergoing radical cystectomy treated with neoadjuvant chemotherapy comprising ifosfamide, doxorubicin, and gemcitabine followed by cisplatin, gemcitabine, and ifosfamide.
Secondary
* Compare perioperative morbidity and mortality of patients treated with this regimen vs historical standards.
OUTLINE: Patients receive neoadjuvant chemotherapy comprising ifosfamide IV over 3 hours on days 1-4, doxorubicin IV on day 3, gemcitabine IV over 30 minutes on days 2 and 4, and filgrastim (G-CSF) subcutaneously on days 7-12 or until blood counts recover. Treatment repeats every 3 weeks for a total of 3 courses. Patients then receive cisplatin IV, gemcitabine IV over 90 minutes, and ifosfamide IV over 30 minutes on day 1. Treatment repeats every 2 weeks for a total of 4-6 courses. Four to six weeks after the completion of all neoadjuvant chemotherapy, patients undergo cystectomy.
Patients are followed at 9, 12, 15, 18, 24, and 30 months and then annually thereafter.
PROJECTED ACCRUAL: A total of 31-49 patients will be accrued for this study within 16-25 months.
Study Oversight
Has Oversight DMC:
False
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?: