Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00310011
Status:
COMPLETED
Last Update Posted:
2018-08-10
First Post:
2006-03-29
Brief Title:
Gemcitabine Paclitaxel and Cisplatin in Treating Patients With Advanced Cancer of the Urothelium
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
A Phase II Trial of Gemzar Gemcitabine Taxol Paclitaxel and Platinol Cisplatin GTP in Treatment of Advanced Transitional Cell Carcinoma of the Urothelium
Status:
COMPLETED
Status Verified Date:
2018-08
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 such as gemcitabine paclitaxel and cisplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving gemcitabine together with paclitaxel and cisplatin works in treating patients with advanced transitional cell cancer of the urothelium
PURPOSE This phase II trial is studying how well giving gemcitabine together with paclitaxel and cisplatin works in treating patients with advanced transitional cell cancer of the urothelium
Detailed Description:
OBJECTIVES
Determine response to gemcitabine hydrochloride paclitaxel and cisplatin GTP among patients with regional or distant metastases of transitional cell carcinoma of the urothelium or localregional recurrence after cystoprostatectomy
Determine response in patients who receive GTP as the initial chemotherapeutic treatment as well as in patients who have received prior chemotherapy
Determine response duration freedom from progression and overall survival
Assess the toxicity of GTP
OUTLINE This is an open-label study Patients are stratified according to prior chemotherapy yes vs no
Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Patients achieving a partial response or complete response undergo surgical restaging and debulking Four to 6 weeks later patients receive 2 additional courses of chemotherapy
After completion of study treatment patients are followed every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A total of 71 patients will be accrued for this study
Determine response to gemcitabine hydrochloride paclitaxel and cisplatin GTP among patients with regional or distant metastases of transitional cell carcinoma of the urothelium or localregional recurrence after cystoprostatectomy
Determine response in patients who receive GTP as the initial chemotherapeutic treatment as well as in patients who have received prior chemotherapy
Determine response duration freedom from progression and overall survival
Assess the toxicity of GTP
OUTLINE This is an open-label study Patients are stratified according to prior chemotherapy yes vs no
Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Patients achieving a partial response or complete response undergo surgical restaging and debulking Four to 6 weeks later patients receive 2 additional courses of chemotherapy
After completion of study treatment patients are followed every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A total of 71 patients 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 |
|---|---|---|---|
| CDR0000466059 | REGISTRY | None | None |
| CCCWFU-BG98-217 | None | None | None |
| AMGEN-CCCWFU-88197 | Registry Identifier | PDQ Physician Data Query | None |