Celecoxib in Treating Patients With Bladder Cancer
- Registration Number
- NCT00006124
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
This randomized phase IIb/III 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 152
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm II (placebo) placebo Patients receive oral placebo twice daily. Arm I (celecoxib) celecoxib Patients receive oral celecoxib twice daily.
- Primary Outcome Measures
Name Time Method Time to recurrence 3 years
- Secondary Outcome Measures
Name Time Method Adverse events as measured by NCI CTC v2.0 3 years Correlation of biomarkers with tumor recurrence 3 years Modulation of biomarkers 3 years Quality of life as measured by EORTC QLQ-C30 v3.0 Up to 24 months
Trial Locations
- Locations (1)
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States