Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080795
Status:
COMPLETED
Last Update Posted:
2012-10-22
First Post:
2004-04-07
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:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
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:
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 |
|---|---|---|---|
| ID01-317 | OTHER | UT MD Anderson Cancer Center | None |
| MDA-ID-01317 | None | None | None |