Name of the Trial
Phase IIB/III Randomized Chemoprevention Study of Celecoxib in Patients with Superficial Transitional Cell Carcinoma of the Bladder at High Risk for Recurrence (MDA-ID-99368). See the protocol summary at http://cancer.gov/clinicaltrials/MDA-ID-99368.

Principal Investigator
Dr. Anita L. Sabichi of the University of Texas M.D. Anderson Cancer Center

Why Is This Trial Important?
Most patients with newly diagnosed bladder cancer have superficial bladder tumors (i.e., tumors that have not spread beyond the lining of the bladder). Patients with superficial bladder cancer can often be cured by surgery. However, the risk of the cancer returning following potentially curative surgery is high.

Celecoxib (Celebrex), a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID), has shown promise in animal studies for the prevention of many cancers (e.g., bladder, colorectal, esophageal, skin, breast, and prostate). It has also been proven to reduce colorectal polyps in patients with familial adenomatous polyposis, a condition that leads to the development of colorectal cancer. This trial will study the effectiveness of celecoxib in preventing the recurrence of superficial bladder cancer, which is characterized by high levels of the COX-2 enzyme.

"NSAIDs are arguably the most promising chemopreventive agents for epithelial cancers, such as bladder cancer," said Dr. Jaye Viner of the NCI Division of Cancer Prevention. "With this trial, we are exploring the possible benefits of celecoxib in bladder cancer patients who are at high risk for recurrence.

"Superficial bladder cancer often recurs, even after potentially curative surgery and standard follow-up treatment. There is a strong need to develop safe and effective interventions to reduce this risk," added Dr. Viner.

Who Can Join This Trial?
Researchers seek to enroll 152 patients aged 18 and over with superficial transitional cell carcinoma of the bladder. See the full list of eligibility criteria for this trial at http://cancer.gov/clinicaltrials/MDA-ID-99368.

Where Is This Trial Taking Place?
The University of Texas M.D. Anderson Cancer Center is coordinating this trial. Multiple study sites in the United States are recruiting patients to participate. A complete list of study sites is available from study investigators listed at http://cancer.gov/clinicaltrials/MDA-ID-99368.

Who to Contact
See the list of study contacts at http://cancer.gov/clinicaltrials/MDA-ID-99368 or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and completely confidential.