Fox Chase

Principal Investigator:	Seth Cohen, MD
Time frame of study:	Ongoing
Location of Study:	Beth Israel Medical Center St.Luke's-Roosevelt Hospital Center
Contact:	Continuum Cancer Research Program (212) 844-6286

Summary:
While advanced urothelial cancers are incurable, they are responsive to combination chemotherapy, which has been shown to improve median survival times. However, the toxicity of these combination chemotherapy regimens remains a major barrier to progress in the treatment of this cancer. In the search for effective, but more tolerable treatment options, the present study will evaluate the activity of the chemotherapy drug cetuximab as a single agent or in combination with paclitaxel for advanced urothelial cancer. Cetuximab binds to and inhibits epidermal growth factor receptors (EGFR) on normal and tumor cells; EGFRs stimulate cell growth when activated by growth factors and are involved in the development and progression of many tumors and cancers. Strong expression of EGFR is found in approximately 50% of bladder cancers. With the early success of EGFR inhibitors such as cetuximab in lung and colorectal cancers, it is logical to consider this agent for urothelial cancer. The cetuximab/paclitaxel combination combines antitumor and antiangiogenic (inhibits formation of new blood vessels) effects, and a favorable interaction of this combination has been reproduced in in vivo cancer models.

Eligibility and Treatment Plan:
Patients, 18 years and older, with histologically confirmed carcinoma of the urothelium (bladder, renal pelvis, ureter) who have received one prior regimen for advanced or metastatic disease.

This study has two treatment arms: Arm A is cetuximab therapy only, and Arm B is cetuximab and paclitaxel combination therapy. For both arms, treatment is administered intravenously every week. A cycle of treatment is defined as 4 weeks, regardless of the number of doses received. Please call for more information.

Benefits and/or Compensation:
Participants receive study-related medication at no charge under the supervision and care of a team of medical professionals. The information gathered from this study may be beneficial to future patients, and cetuximab may improve overall survival time for advanced urothelial cancer patients.