Preventing Bladder Cancer Recurrence and Progression
Name of the Trial
Phase 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.
Dr. Arie Belldegrun of the Jonsson Comprehensive Cancer Center, UCLA
Why This Trial Is 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.
This trial is no longer accepting new patients. To locate other clinical trials for bladder cancer, search the NCI's database of clinical trials 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.