Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00380029
Status:
COMPLETED
Last Update Posted:
2017-07-19
First Post:
2006-09-22
Brief Title:
Erlotinib Before and After Surgery in Treating Patients With Muscle-Invasive Bladder Cancer
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
A Phase II Study of Erlotinib Tarceva in Patients With Muscle-Invasive Bladder Cancer Undergoing Radical Cystectomy
Status:
COMPLETED
Status Verified Date:
2017-06
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 Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Giving erlotinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed Giving erlotinib after surgery may kill any tumor cells that remain after surgery
PURPOSE This phase II trial is studying how well erlotinib works when given before and after surgery in treating patients with muscle-invasive bladder cancer
PURPOSE This phase II trial is studying how well erlotinib works when given before and after surgery in treating patients with muscle-invasive bladder cancer
Detailed Description:
OBJECTIVES
Primary
Determine the effect of neoadjuvant erlotinib hydrochloride on histopathological molecular and genetic correlates in patients undergoing radical cystectomy for muscle-invasive bladder cancer
Secondary
Determine the pathological complete response rate in surgical specimens from patients treated with this drug
Determine recurrence and progression rates after cystectomy up to 2 years after surgery in patients treated with neoadjuvant and adjuvant erlotinib hydrochloride
Determine 2- and 5-year disease-free disease-specific and overall survival rates in patients treated with this drug
Determine the safety of this drug in these patients
OUTLINE This is an open-label study
Patients receive oral erlotinib hydrochloride once daily for 4 weeks Patients then undergo radical cystectomy with curative intent Within 12 weeks after surgery patients resume oral erlotinib hydrochloride once daily for up to 2 years in the absence of disease progression or unacceptable toxicity
Note Patients who are candidates for adjuvant chemotherapy eg found to have pathologic stage T3 pT3 Node positive N disease do not receive erlotinib hydrochloride after surgery
Tumor tissue is obtained at baseline at the original or confirmatory transurethral resection of the bladder tumor and at the time of cystectomy for analysis of drug-specific and tissue-based biomarkers by western blot immunohistochemistry and gene array techniques Histopathological molecular and genetic correlates are analyzed to better understand the potential effects of the epidermal growth factor receptor EGFR inhibition in transitional cell carcinoma and to determine the effect of neoadjuvant erlotinib on gene expression Tumor tissue is also evaluated by real-time polymerase chain reaction to confirm drug effects on expected targets and on EGFR expression activity and affected signaling pathways in the disease state and by microarray analysis to define expression phenotypes correlating with outcome distinguish responders from nonresponders and determine effects of drug treatment on gene expression in disease
Patients are followed periodically for up to 5 years after surgery
Primary
Determine the effect of neoadjuvant erlotinib hydrochloride on histopathological molecular and genetic correlates in patients undergoing radical cystectomy for muscle-invasive bladder cancer
Secondary
Determine the pathological complete response rate in surgical specimens from patients treated with this drug
Determine recurrence and progression rates after cystectomy up to 2 years after surgery in patients treated with neoadjuvant and adjuvant erlotinib hydrochloride
Determine 2- and 5-year disease-free disease-specific and overall survival rates in patients treated with this drug
Determine the safety of this drug in these patients
OUTLINE This is an open-label study
Patients receive oral erlotinib hydrochloride once daily for 4 weeks Patients then undergo radical cystectomy with curative intent Within 12 weeks after surgery patients resume oral erlotinib hydrochloride once daily for up to 2 years in the absence of disease progression or unacceptable toxicity
Note Patients who are candidates for adjuvant chemotherapy eg found to have pathologic stage T3 pT3 Node positive N disease do not receive erlotinib hydrochloride after surgery
Tumor tissue is obtained at baseline at the original or confirmatory transurethral resection of the bladder tumor and at the time of cystectomy for analysis of drug-specific and tissue-based biomarkers by western blot immunohistochemistry and gene array techniques Histopathological molecular and genetic correlates are analyzed to better understand the potential effects of the epidermal growth factor receptor EGFR inhibition in transitional cell carcinoma and to determine the effect of neoadjuvant erlotinib on gene expression Tumor tissue is also evaluated by real-time polymerase chain reaction to confirm drug effects on expected targets and on EGFR expression activity and affected signaling pathways in the disease state and by microarray analysis to define expression phenotypes correlating with outcome distinguish responders from nonresponders and determine effects of drug treatment on gene expression in disease
Patients are followed periodically for up to 5 years after surgery
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 |
|---|---|---|---|
| P30CA016086 | NIH | None | httpsreporternihgovquickSearchP30CA016086 |