Title
Phase II study of neoadjuvant gemcitabine, paclitaxel and carboplatin followed by observation or immediate cystectomy in patients with stage II or III transitional cell cancer of the urothelium

Principal investigators
Primo N. Lara, associate professor of medicine, hematology and oncology, UC Davis School of Medicine and Medical Center Ralph deVere White, assistant dean for cancer programs and professor and chair of urology, UC Davis School of Medicine and Medical Center; director, UC Davis Cancer Center

What is transitional cell cancer of the urothelium?
Transitional cell cancer of the urothelium, sometimes called TCC, can develop in the lining of the bladder, the renal pelvis, the ureter or the urethra. The urethra is the canal through which urine leaves the body. The ureters are hollow muscular tubes that carry urine from the kidneys to the bladder. The renal pelvis is the lower part of each kidney that connects to each ureter. In stage II and III TCC, the cancer has invaded the bladder’s muscular wall. The standard treatment for these cancers has been surgery to remove the bladder.

Why is this trial important?
This trial builds on findings from an earlier national study in which UC Davis Cancer Center specialists participated. In that study, patients with muscle-invasive cancer received chemotherapy combined with bladder removal. After removal, the bladders were examined by a pathologist. These examinations showed that in 40 percent of cases, no signs of tumor remained. Continued follow-up showed that for this 40 percent of the patients, the five-year, disease-free survival rate was 80 percent. With standard treatment, the overall survival rate had been 50- to 60-percent.

The current trial, originated at UC Davis Cancer Center, is designed to determine whether some patients with muscle-invasive disease can avoid removal of the bladder, yet still have an 80-percent survival rate.

Patients in the trial will receive combination chemotherapy consisting of the drugs carboplatin, gemcitabine and paclitaxel, followed by a repeat resection of the area of the bladder where the tumor originally existed. This excised tissue will be staged by a pathologist. Patients with stage T1 disease or greater will undergo immediate bladder removal.

Patients with no remaining cancer may also choose immediate bladder removal. Or, they may choose to undergo observation instead. Patients who choose observation will receive periodic cystoscopy exams. Cystoscopy is a visual inspection of the bladder using a cystoscope, a slender tube, fitted with a lens and light, that can be introduced through the urethra. A biopsy tool can be inserted through the tube, permitting the surgeon to take tissue samples during the exam. For patients who choose observation, surgery to remove the bladder will be performed only if the cancer recurs.

Who can join this trial?
Researchers seek to enroll 95 patients ages 18 and over who have muscle-invasive (T2-T4a), node-negative transitional cell cancer of the urothelium. For a complete list of eligibility criteria, please visit http://clinicaltrials.gov/show/NCT00045630.

Where is this trial taking place?
This study is under way at UC Davis Cancer Center and 94 other centers in 30 states.

For more information, please contact study coordinator Christine Reed at (916) 734-4913. Or to learn more about this and other clinical trials available at UC Davis Cancer Center, please visit http://www.ucdaviscancerclinicaltrials.org.