Name of the Trial
Phase I/II Study of Paclitaxel and Radiotherapy with or without Trastuzumab (Herceptin) in Patients Who Have Undergone Prior Transurethral Bladder Resection for Muscle-Invasive Transitional Cell Carcinoma of the Bladder (RTOG-0524).  See the protocol summary at http://www.cancer.gov/clinicaltrials/RTOG-0524.

Principal Investigators
Drs. M. Dror Michaelson, Alan Pollack, and Douglas Dahl, Radiation Therapy Oncology Group

Why This Trial Is Important
Complete removal of the bladder, or cystectomy, is the most common treatment for bladder cancer that has invaded the organ’s muscle wall. However, to preserve the bladder and improve the quality of life for patients, doctors have developed a method for treating bladder cancer that uses a combination of chemotherapy and daily radiation therapy.

Previous clinical trials of this method have included only patients who were eligible for cystectomy, in the event that the bladder-preserving therapy failed. For patients who are not suitable for cystectomy, no standard treatment options currently exist.

In this trial, patients with invasive bladder cancer who are not suitable for cystectomy will be treated with the drug paclitaxel and daily radiation therapy. Also, patients whose tumors test positive for the protein HER2 will be treated with the monoclonal antibody trastuzumab (Herceptin).

Some studies have suggested that 40–80 percent of bladder cancer tumors produce increased amounts of HER2 and that patients with such tumors tend to fare poorly compared to patients whose tumors do not overexpress this protein. Trastuzumab binds to HER2 on the surface of tumor cells and initiates a cytotoxic process.

“Patients with muscle-invasive bladder cancer who are not suitable for surgery have few options for treatment,” said Dr. Michaelson. “With this trial we’re testing what we hope to be a fairly gentle means of treatment using combination therapy developed for bladder preservation.

For More Information
See the list of entry criteria and trial contact information at http://cancer.gov/clinicaltrials/RTOG-0524 or call NCI’s Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and confidential.