Celecoxib in Treating Patients With Bladder Cancer
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Phase IIb/III Chemoprevention Trial of Celecoxib to Prevent Recurrence of Superficial Bladder Cancer|
- Time to recurrence [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Modulation of biomarkers [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Correlation of biomarkers with tumor recurrence [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Adverse events as measured by NCI CTC v2.0 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Quality of life as measured by EORTC QLQ-C30 v3.0 [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2000|
|Study Completion Date:||April 2008|
|Primary Completion Date:||March 2006 (Final data collection date for primary outcome measure)|
Experimental: Arm I (celecoxib)
Patients receive oral celecoxib twice daily.
Placebo Comparator: Arm II (placebo)
Patients receive oral placebo twice daily.
Other Name: PLCB
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 marker(s) 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006124
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Anita Sabichi||M.D. Anderson Cancer Center|