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Combination Therapy for Invasive Bladder Cancer
Untitled Document
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.
Principal Investigators
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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 or call the NCI's Cancer Information
Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and confidential.
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