Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002684
Status:
COMPLETED
Last Update Posted:
2013-07-03
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Patients With Advanced Urinary Tract Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Trial of Paclitaxel Cisplatin and Ifosfamide in Patients With Advanced Urothelial Tumors
Status:
COMPLETED
Status Verified Date:
2013-07
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 cisplatin ifosfamide and paclitaxel use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug and giving drugs in different ways may kill more tumor cells
PURPOSE This phase II trial is studying how well combination chemotherapy works in treating patients with metastatic urinary tract cancer that cannot be treated with surgery
PURPOSE This phase II trial is studying how well combination chemotherapy works in treating patients with metastatic urinary tract cancer that cannot be treated with surgery
Detailed Description:
OBJECTIVES
Determine the efficacy of cisplatin ifosfamide and paclitaxel in patients with unresectable or metastatic urothelial cancer nontransitional cell histologies
OUTLINE Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-3 Filgrastim G-CSF is administered subcutaneously daily beginning on day 6 and continuing through day 17 or until blood counts recover Treatment continues every 3 weeks for a maximum of 6 courses in the absence of stable or progressive disease after completion of course 2 or complete response after completion of course 4
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 2 years
Determine the efficacy of cisplatin ifosfamide and paclitaxel in patients with unresectable or metastatic urothelial cancer nontransitional cell histologies
OUTLINE Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-3 Filgrastim G-CSF is administered subcutaneously daily beginning on day 6 and continuing through day 17 or until blood counts recover Treatment continues every 3 weeks for a maximum of 6 courses in the absence of stable or progressive disease after completion of course 2 or complete response after completion of course 4
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 2 years
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 |
|---|---|---|---|
| NCI-V95-0743 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000064373 | REGISTRY | None | None |