Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: 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.

PURPOSE: 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.

Further Study Information

OBJECTIVES:

• 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.

• 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.

• Determine the toxicity of celecoxib in these patients.

• 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.

PROJECTED ACCRUAL: A total of 152 patients will be accrued for this study.

Eligibility Criteria

Inclusion Criteria:

1. ³18 yrs.old with histologically documented transitional cell carcinoma (TCC)of the bladder: Ta (G3,multifocal or ³2 tumors w/in 12 months), and/or T1 and/or Tis.

2. Transurethral resection of bladder tumour (TURBT) within 9 months of randomization.

3. 6 weekly doses of induction Bacille Calmette-Guérin (BCG) and 3 doses of maintenance BCG.

4. NED (without evidence of disease) by cystoscopy and cytology at the post-induction cystoscopy.

5. Negative Intravenous Pyelogram (IVP) or other upper tract imaging study within 9 months prior to randomization.

6. Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (PS) = 0 - 2.

7. Adequate bone marrow, hepatic, and renal function within 4 weeks of randomization.

Exclusion Criteria:

1. TCC involves the prostatic urethra or upper urinary tract

2. Use of aspirin (> 100 mg/day) or other Nonsteroidal Antiinflammatory Drugs (NSAIDs) 14 days prior to randomization.

3. Oral or IV corticosteroids for> 2 weeks or inhaled corticosteroids for > 4 weeks 6 months prior to randomization.

4. Active Gastrointestinal (GI) disease, renal, hepatic, or bleeding disorder.

5. Adverse reactions to sulfonamides, COX-2 inhibitors, salicylates, or other NSAIDs.

6. Use of lithium or fluconazole.

7. Specific cardiovascular disease history.

8. Increased cardiovascular risk must be controlled by cardiologist, internist, or primary care physician.

Trial Contact Information

Trial Lead Organizations/Sponsors

M. D. Anderson Cancer Center at University of Texas

Anita L. Sabichi, MD

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00006124
Information obtained from ClinicalTrials.gov on December 14, 2011

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