Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084578
Status:
WITHDRAWN
Last Update Posted:
2013-07-15
First Post:
2004-06-10
Brief Title:
Celecoxib and Rosiglitazone in Treating Patients Who Are Undergoing Cystoscopic Surveillance for Early-Stage Noninvasive Carcinoma of the Bladder or Radical Cystectomy for Muscle-Invasive Carcinoma of the Bladder
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
A Randomized Trial of Celecoxib and Rosiglitazone Alone and in Combination in Patients With Early Stage Non-Invasive Bladder Carcinoma Undergoing Cystoscopic Surveillance and in Patients With Muscle-Invasive Bladder Cancer Undergoing Radical Cystectomy
Status:
WITHDRAWN
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn due to drug toxicity
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor Rosiglitazone may help tumor cells develop into normal bladder cells
PURPOSE This randomized clinical trial is studying how well giving celecoxib together with rosiglitazone works in treating patients who are undergoing cystoscopic surveillance screening for early-stage noninvasive carcinoma in situ carcinoma cancer of the bladder or radical cystectomy for muscle-invasive carcinoma cancer has spread into the muscle layer of bladder tissue of the bladder
PURPOSE This randomized clinical trial is studying how well giving celecoxib together with rosiglitazone works in treating patients who are undergoing cystoscopic surveillance screening for early-stage noninvasive carcinoma in situ carcinoma cancer of the bladder or radical cystectomy for muscle-invasive carcinoma cancer has spread into the muscle layer of bladder tissue of the bladder
Detailed Description:
OBJECTIVES
Primary
Determine whether rosiglitazone and celecoxib administered alone or in combination cause changes in the expression of effector molecules peroxisome proliferator-activated receptor-γ PPAR-γ and cyclo-oxygenase-1 COX-1 in patients with early-stage non-invasive carcinoma of the bladder undergoing cystoscopic surveillance or in patients with muscle-invasive carcinoma of the bladder undergoing radical cystectomy
Secondary
Determine whether these regimens result in changes in the expression of downstream effector molecules that mediate cellular proliferation and apoptosis in these patients
Determine the relationship between tissue levels of biomarkers of drug effect proliferation and apoptosis and the systemic biomarkers of response to treatment in terms of COX-2 activity and the levels of the endogenous PPAR-γ ligand in patients treated with these regimens
Determine the toxicity of these regimens in these patients
Determine the frequency of recurrence and the time to progression in patients undergoing cystoscopic surveillance
OUTLINE This is a randomized pilot cohort study Patients are assigned to 1 of 2 cohorts according to disease stage Ta Tis T1 N0 M0 vs T2-4 NX M0
Stage 1
Cohort 1 Patients receive oral celecoxib twice daily and oral rosiglitazone once daily for 1 year in the absence of disease progression or unacceptable toxicity
Cohort 2 Patients receive oral celecoxib twice daily and oral rosiglitazone once daily for 14 days Patients then undergo cystectomy
Stage 2 Patients are randomized into 1 of 2 treatment arms
Arm I
Cohort 1 Patients receive oral celecoxib twice daily for 1 year in the absence of disease progression or unacceptable toxicity
Cohort 2 Patients receive oral celecoxib twice daily for 14 days Patients then undergo cystectomy
Arm II
Cohort 1 Patients receive oral rosiglitazone once daily for 1 year in the absence of disease progression or unacceptable toxicity
Cohort 2 Patients receive oral rosiglitazone once daily for 14 days Patients then undergo cystectomy
Patients in cohort 1 in both stages undergo cystoscopic surveillance every 3 months
PROJECTED ACCRUAL A total of 120 patients 20 per cohort in study stage 1 40 per treatment arm 20 per cohort in each arm in study stage 2 will be accrued for this study within 12-18 months
Primary
Determine whether rosiglitazone and celecoxib administered alone or in combination cause changes in the expression of effector molecules peroxisome proliferator-activated receptor-γ PPAR-γ and cyclo-oxygenase-1 COX-1 in patients with early-stage non-invasive carcinoma of the bladder undergoing cystoscopic surveillance or in patients with muscle-invasive carcinoma of the bladder undergoing radical cystectomy
Secondary
Determine whether these regimens result in changes in the expression of downstream effector molecules that mediate cellular proliferation and apoptosis in these patients
Determine the relationship between tissue levels of biomarkers of drug effect proliferation and apoptosis and the systemic biomarkers of response to treatment in terms of COX-2 activity and the levels of the endogenous PPAR-γ ligand in patients treated with these regimens
Determine the toxicity of these regimens in these patients
Determine the frequency of recurrence and the time to progression in patients undergoing cystoscopic surveillance
OUTLINE This is a randomized pilot cohort study Patients are assigned to 1 of 2 cohorts according to disease stage Ta Tis T1 N0 M0 vs T2-4 NX M0
Stage 1
Cohort 1 Patients receive oral celecoxib twice daily and oral rosiglitazone once daily for 1 year in the absence of disease progression or unacceptable toxicity
Cohort 2 Patients receive oral celecoxib twice daily and oral rosiglitazone once daily for 14 days Patients then undergo cystectomy
Stage 2 Patients are randomized into 1 of 2 treatment arms
Arm I
Cohort 1 Patients receive oral celecoxib twice daily for 1 year in the absence of disease progression or unacceptable toxicity
Cohort 2 Patients receive oral celecoxib twice daily for 14 days Patients then undergo cystectomy
Arm II
Cohort 1 Patients receive oral rosiglitazone once daily for 1 year in the absence of disease progression or unacceptable toxicity
Cohort 2 Patients receive oral rosiglitazone once daily for 14 days Patients then undergo cystectomy
Patients in cohort 1 in both stages undergo cystoscopic surveillance every 3 months
PROJECTED ACCRUAL A total of 120 patients 20 per cohort in study stage 1 40 per treatment arm 20 per cohort in each arm in study stage 2 will be accrued for this study within 12-18 months
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 |
|---|---|---|---|
| CDR0000365460 | REGISTRY | PDQ Physician Data Query | None |