Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028860
Status:
COMPLETED
Last Update Posted:
2013-07-10
First Post:
2002-01-04
Brief Title:
Combination Chemotherapy Following Surgery in Treating Patients With Urinary Tract Cancer
Sponsor:
Tulane University Health Sciences Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial Of Adjuvant Chemotherapy For High Risk Transitional Cell Carcinoma Of The Urothelium
Status:
COMPLETED
Status Verified Date:
2004-08
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy following surgery in treating patients who have urinary tract cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy following surgery in treating patients who have urinary tract cancer
Detailed Description:
OBJECTIVES
Determine the time to treatment failure and disease-free survival in patients with high-risk transitional cell carcinoma of the urothelium treated with adjuvant paclitaxel ifosfamide carboplatin and gemcitabine
Determine the tolerability and feasibility of this regimen in these patients
OUTLINE Patients are stratified according to disease stage
Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1 hour on day 1 ifosfamide IV over 1 hour on days 1-3 and filgrastim G-CSF subcutaneously SC once daily beginning on day 4 and continuing until blood counts recover Treatment repeats every 21 days for a total of 2 courses
Beginning 3 weeks after the completion of the second course of chemotherapy patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 1 hour on day 1 Patients also receive G-CSF SC once daily on days 2-6 and again beginning on day 9 and continuing until blood counts recover Treatment repeats every 21 days for a total of 2 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 3 months every 6 months for 2 years and then annually for 3 years
PROJECTED ACCRUAL A total of 10-30 patients will be accrued for this study
Determine the time to treatment failure and disease-free survival in patients with high-risk transitional cell carcinoma of the urothelium treated with adjuvant paclitaxel ifosfamide carboplatin and gemcitabine
Determine the tolerability and feasibility of this regimen in these patients
OUTLINE Patients are stratified according to disease stage
Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1 hour on day 1 ifosfamide IV over 1 hour on days 1-3 and filgrastim G-CSF subcutaneously SC once daily beginning on day 4 and continuing until blood counts recover Treatment repeats every 21 days for a total of 2 courses
Beginning 3 weeks after the completion of the second course of chemotherapy patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 1 hour on day 1 Patients also receive G-CSF SC once daily on days 2-6 and again beginning on day 9 and continuing until blood counts recover Treatment repeats every 21 days for a total of 2 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 3 months every 6 months for 2 years and then annually for 3 years
PROJECTED ACCRUAL A total of 10-30 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BMS-TULCC-RM-002 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000069142 | REGISTRY | None | None |
| AMGEN-TULCC-RM-002 | None | None | None |