Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088946
Status:
COMPLETED
Last Update Posted:
2020-07-31
First Post:
2004-08-04
Brief Title:
Erlotinib and Green Tea Extract Polyphenon E in Preventing Cancer Recurrence in Former Smokers Who Have Undergone Surgery for Bladder Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
Parallel Randomized Double-Blind Placebo Controlled Phase II Adjuvant Studies of Erlotinib and Polyphenon E to Prevent the Recurrence and Progression of Tobacco-Related Superficial Bladder Cancer
Status:
COMPLETED
Status Verified Date:
2012-08
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 Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth Green tea extract Polyphenon E contains certain ingredients that may slow the growth of tumor cells and prevent the recurrence of cancer Giving erlotinib or green tea extract after surgery may kill any remaining tumor cells and may prevent the recurrence of bladder cancer
PURPOSE This randomized phase II trial is studying how well giving erlotinib together with green tea extract works in preventing cancer recurrence in former smokers who have undergone surgery for bladder cancer
PURPOSE This randomized phase II trial is studying how well giving erlotinib together with green tea extract works in preventing cancer recurrence in former smokers who have undergone surgery for bladder cancer
Detailed Description:
OBJECTIVES
Primary
Compare the effects of erlotinib vs green tea extract Polyphenon E vs placebo on the 2-year recurrence rate in former smokers with resected superficial transitional cell carcinoma of the bladder
Develop an effective chemopreventative strategy as an adjunct to standard care for the medical management of superficial bladder cancer in these patients
Secondary
Determine the toxic effects associated with these drugs in these patients
Determine a safe and effective chemopreventative dose of erlotinib in these patients
Correlate the modulation of 1 or more biomarkers with bladder cancer recurrence andor progression in patients treated with these drugs
Determine the risk of clinical bladder cancer progression in patients treated with these drugs
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to disease stage Ta vs T1 vs carcinoma in situ and participating center Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive oral erlotinib and oral green tea extract Polyphenon E placebo once daily
Arm II Patients receive oral green tea extract Polyphenon E and oral erlotinib placebo once daily
Arm III Patients receive oral erlotinib placebo and oral green tea extract placebo once daily
In all arms treatment continues for 12 months in the absence of disease recurrence or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 330 patients 110 per treatment arm will be accrued for this study within 3 years
Primary
Compare the effects of erlotinib vs green tea extract Polyphenon E vs placebo on the 2-year recurrence rate in former smokers with resected superficial transitional cell carcinoma of the bladder
Develop an effective chemopreventative strategy as an adjunct to standard care for the medical management of superficial bladder cancer in these patients
Secondary
Determine the toxic effects associated with these drugs in these patients
Determine a safe and effective chemopreventative dose of erlotinib in these patients
Correlate the modulation of 1 or more biomarkers with bladder cancer recurrence andor progression in patients treated with these drugs
Determine the risk of clinical bladder cancer progression in patients treated with these drugs
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to disease stage Ta vs T1 vs carcinoma in situ and participating center Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive oral erlotinib and oral green tea extract Polyphenon E placebo once daily
Arm II Patients receive oral green tea extract Polyphenon E and oral erlotinib placebo once daily
Arm III Patients receive oral erlotinib placebo and oral green tea extract placebo once daily
In all arms treatment continues for 12 months in the absence of disease recurrence or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 330 patients 110 per treatment arm will be accrued for this study within 3 years
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 |
|---|---|---|---|
| UCLA-0301091-03 | None | None | None |