Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136175
Status:
COMPLETED
Last Update Posted:
2015-01-21
First Post:
2005-08-25
Brief Title:
Paclitaxel Carboplatin and Gemcitabine in the Treatment of Patients With Advanced Transitional Cell Cancer of the Bladder
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
University of Michigan Rogel Cancer Center
Study Overview
Official Title:
Phase II Trial of Paclitaxel Carboplatin and Gemcitabine in Patients With Locally Advanced Transitional Cell Carcinoma of the Bladder
Status:
COMPLETED
Status Verified Date:
2015-01
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:
This trial will evaluate the efficacy and safety of combination chemotherapy paclitaxel carboplatin and gemcitabine prior to surgery in the treatment of patients with locally advanced transitional cell cancer of the bladder
Detailed Description:
This is a Phase II trial of neoadjuvant chemotherapy with paclitaxel carboplatin and gemcitabine in the treatment of locally advanced transitional cell carcinoma of the bladder Patients will be stratified based on extent of disease Patients with T3 N0 disease will receive 3 cycles of chemotherapy and then proceed to cystectomy Patients with T4 disease or any patient with N1-3 disease will receive 3 cycles of therapy followed by assessment of response Patients with evidence of response will then receive an additional three cycles of therapy with reassessment of resectability after cycles 6 Correlative Studies Tumor specimens obtained at initial biopsy will be assayed for expression of p53 Rb and p21
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