Name of the Trial
Name of the TrialPhase II Randomized Study of Adjuvant Erlotinib and Green Tea Extract (Polyphenon E) in Preventing Recurrence and Progression in Former Smokers with Resected High-Grade Superficial Transitional Cell Carcinoma of the Bladder (UCLA-0301091-02). See the protocol summary at http://cancer.gov/clinicaltrials/ UCLA-0301091-02.

Principal Investigator
Dr. Arie Belldegrun of the Jonsson Comprehensive Cancer Center, UCLA

Why Is This Trial Important?
Most patients diagnosed with bladder cancer have tumors that have not penetrated the muscle of the bladder wall (superficial bladder cancer). Even with successful surgery, however, recurrence is common.

Researchers are interested in developing effective drug therapies to prevent bladder cancer recurrence after surgery. The use of drugs to prevent cancer or cancer recurrence is called chemoprevention. In this study, two types of drugs are being evaluated to see whether they are effective in preventing bladder cancer recurrence and progression after surgery in patients with a history of smoking.

One of the drugs, Polyphenon E (Mitsui Norin Co. Ltd.), is made from green tea. "Preclinical studies have shown that substances called catechins in green tea extracts are very good at preventing bladder cancer cells from multiplying," said Dr. Belldegrun.

The other drug, erlotinib (Tarceva, OSI Pharmaceuticals), which was recently approved to treat lung cancer, inhibits a protein called epidermal growth factor receptor (EGFR). Approximately 50 percent of bladder tumors show high levels of EGFR, and EGFR expression has been associated with bladder tumor aggressiveness.

"With this study, we hope to find a way to prevent recurrence and, more importantly, to prevent progression of bladder cancer in patients with a history of smoking," Dr. Belldegrun added.

Who Can Join This Trial?
Researchers seek to enroll 330 former smokers aged 19 and over with a confirmed diagnosis of transitional cell carcinoma (TCC) of the bladder. See the full list of eligibility criteria for this trial at http://cancer.gov/clinicaltrials/UCLA-0301091-02.

Where Is This Trial Taking Place?
Study sites in the United States are enrolling patients in this trial. See the list of study sites at http://cancer.gov/clinicaltrials/UCLA-0301091-02.

Contact Information
See the list of study contacts at http://cancer.gov/clinicaltrials/UCLA-0301091-02 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.