CTSU CALGB 90601: Transitional Cell / Bladder
CTSU CALGB 90601: A RANDOMIZED DOUBLE-BLIND PHASE III STUDY COMPARING GEMCITABINE, CISPLATIN, AND BEVACIZUMAB TO GEMCITABINE, CISPLATIN, AND PLACEBO IN PATIENTS WITH ADVANCED TRANSITIONAL CELL CARCINOMA
Approval Date: 12/31/1969
Principal Investigator: Michael Stender, M.D.
The purpose of this study is to compare the effects, both good and bad, of the combination of chemotherapy drugs gemcitabine and cisplatin with the combination of chemotherapy drugs gemcitabine, cisplatin, and the experimental drug bevacizumab on you and your urinary tract cancer (transitional cell cancer) and to find out which is better. Bevacizumab is an antibody that we think can block a protein called VEGF and inhibit the growth of new blood vessels. Bevacizumab has been approved by the FDA for the treatment of metastatic colorectal, lung, and breast cancer, but it is not FDA approved for transitional cell carcinoma and should be considered experimental.
- Metastatic or unresectable transitional cell carcinoma of the urinary tract (renal pelvis, ureter, bladder, prostate, or urethra).
- Patients must not be candidates for potentially curative surgery or radiotherapy.
- No prior combination systemic chemotherapy for metastatic disease.
- At least one year from completion of prior neoadjuvant or adjuvant systemic chemotherapy and diagnosis of metastatic disease.
- No prior treatment with bevacizumab or other angiogenesis inhibitors.
- No arterial thrombotic events within 6 months.
Status of Clinical Trial:
open and enrolling