Trial Information

CTSU-CALGB 90601 Phase III Randomized Study of Gemcitabine Hydrochloride and Cisplatin With Versus Without Bevacizumab in Patients With Advanced Transitional Cell Carcinoma of the Urinary Tract

Compare the overall survival of patients with advanced transitional cell carcinoma of the urinary tract treated with gemcitabine hydrochloride, cisplatin, and bevacizumab vs gemcitabine hydrochloride, cisplatin, and placebo.

Patient Inclusion Criteria:

Histologically or cytologically confirmed transitional (urothelial) cell carcinoma of the urinary tract (renal pelvis, ureter, bladder, prostate, or urethra)
Unresectable metastatic or locally advanced disease (T4b, N2, N3, or M1)
Not a candidate for potentially curative surgery or radiotherapy
No history of peritoneal carcinomatosis
No known brain metastases

Patient Exclusion Criteria:

At least 4 weeks since prior intravesical therapy
At least 7 days since any minor surgery such as port placement
No prior combination systemic chemotherapy for metastatic disease
Single-agent radiosensitizing chemotherapy is not considered prior systemic therapy
Prior neoadjuvant or adjuvant systemic chemotherapy allowed provided it was completed = 1 year prior to the diagnosis of metastatic disease
No prior bevacizumab or other angiogenesis inhibitors

Janeen V. Bazan, RN OCN BSN CCRP, Oncology Research Nurse Program Coordinator
Sherman Health
1425 North Randall Road
Elgin, IL 60123
Phone: 224-783-2907
Fax: 224-783-3071
Email: janeen.bazan@shermanhospital.org

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Research Center Information: Sherman Health

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