Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006124
Status:
COMPLETED
Last Update Posted:
2013-02-13
First Post:
2000-08-03
Brief Title:
Celecoxib in Treating Patients With Bladder Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase IIbIII Chemoprevention Trial of Celecoxib to Prevent Recurrence of Superficial Bladder Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
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 randomized phase IIbIII trial is studying celecoxib to see how well it works in preventing disease recurrence in patients who have bladder cancer Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer The use of celecoxib may be an effective way to prevent the recurrence of bladder cancer
Detailed Description:
OBJECTIVES
I Compare the time to recurrence after treatment with celecoxib vs placebo in patients with superficial transitional cell carcinoma of the bladder at high risk for recurrence
II Correlate the modulation of one or more biomarkers with recurrence of bladder cancer and confirm the value of the markers as a surrogate endpoint biomarker for bladder cancer and celecoxib
III Determine the toxicity of celecoxib in these patients IV Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to center and presence of Tis disease yes vs no Patients are randomized to one of two arms
Arm I Patients receive oral celecoxib twice daily
Arm II Patients receive oral placebo twice daily
Treatment continues in both arms for 1-2 years in the absence of unacceptable toxicity development of recurrent or invasive bladder carcinoma or development of a second malignancy requiring radiotherapy or systemic therapy
Quality of life is assessed at baseline and at week 54
Patients are followed at 6 weeks and then every 12 weeks until the last randomized patient has been on the study for 1 year or until disease recurrence
I Compare the time to recurrence after treatment with celecoxib vs placebo in patients with superficial transitional cell carcinoma of the bladder at high risk for recurrence
II Correlate the modulation of one or more biomarkers with recurrence of bladder cancer and confirm the value of the markers as a surrogate endpoint biomarker for bladder cancer and celecoxib
III Determine the toxicity of celecoxib in these patients IV Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to center and presence of Tis disease yes vs no Patients are randomized to one of two arms
Arm I Patients receive oral celecoxib twice daily
Arm II Patients receive oral placebo twice daily
Treatment continues in both arms for 1-2 years in the absence of unacceptable toxicity development of recurrent or invasive bladder carcinoma or development of a second malignancy requiring radiotherapy or systemic therapy
Quality of life is assessed at baseline and at week 54
Patients are followed at 6 weeks and then every 12 weeks until the last randomized patient has been on the study for 1 year or until disease recurrence
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 |
|---|---|---|---|
| ID99-368 | None | None | None |
| N01CN85186 | OTHER_GRANT | US NIH GrantContract Award Number | None |