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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 ³.

Principal Investigators

Dr. M. Dror Michaelson Principal Investigator

Dr. M. Dror Michaelson, Dr. Alan Pollack, and Dr. 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 clinical trial, patients with invasive bladder cancer who are not suitable for cystectomy will be treated with the drug paclitaxel and daily radiation therapy. Additionally, patients whose tumors test positive for a protein called 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 (cell-killing) 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.

"In addition to trying to establish a safe and well-tolerated regimen that can be tested in larger clinical trials, we hope to clarify the role of HER2 in bladder cancer and determine if trastuzumab can help improve outcomes for patients whose tumors overexpress that protein," Dr. Michaelson added.

For More Information

See the list of entry criteria and trial contact information ³ or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and confidential.

Glossary Terms

Treatment with drugs that kill cancer cells.

A protein involved in normal cell growth. It is found on some types of cancer cells, including breast and ovarian. Cancer cells removed from the body may be tested for the presence of HER2/neu to help decide the best type of treatment. HER2/neu is a type of receptor tyrosine kinase. Also called c-erbB-2, human EGF receptor 2, and human epidermal growth factor receptor 2.

A drug used to treat breast cancer, ovarian cancer, and AIDS-related Kaposi sarcoma. It is also used together with another drug to treat non-small cell lung cancer. Paclitaxel is also being studied in the treatment of other types of cancer. It blocks cell growth by stopping cell division and may kill cancer cells. It is a type of antimitotic agent. Also called Taxol.

The use of high-energy radiation from x-rays, gamma rays, neutrons, protons, and other sources to kill cancer cells and shrink tumors. Radiation may come from a machine outside the body (external-beam radiation therapy), or it may come from radioactive material placed in the body near cancer cells (internal radiation therapy). Systemic radiation therapy uses a radioactive substance, such as a radiolabeled monoclonal antibody, that travels in the blood to tissues throughout the body. Also called irradiation and radiotherapy.

A monoclonal antibody that binds to HER2 (human epidermal growth factor receptor 2), and can kill HER2-positive cancer cells. Monoclonal antibodies are made in the laboratory and can locate and bind to substances in the body, including cancer cells. Trastuzumab is used to treat breast cancer that is HER2-positive and has spread after treatment with other drugs. It is also used with other anticancer drugs to treat HER2-positive breast cancer after surgery. Trastuzumab is also being studied in the treatment of other types of cancer. Also called Herceptin.