A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients With Advanced Transitional Cell Carcinoma
Study Status
Open to Enrollment
Study Description
The purpose of this trial is to study gemcitabine hydrochloride, cisplatin, and bevacizumab to see how well they work compared with gemcitabine hydrochloride, cisplatin, and placebo in treating patients with advanced urinary tract cancer.
Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether gemcitabine hydrochloride and cisplatin are more effective when given together with or without bevacizumab in treating patients with urinary tract cancer.
Disease Status and/or Stage
Advanced Transitional Cell Carcinoma
Sponsor
Cancer and Leukemia Group B (CALGB); National Cancer Institute (NCI)
Key Eligibility
- Men and women, age 18 and older
- Confirmed transitional cell carcinoma of the urinary tract (renal pelvis, ureter, bladder, prostate, or urethra)
- Not a candidate for potentially curative surgery or radiotherapy
- No history of periotoneal carcinomatosis (a type of secondary cancer that affects the lining of the abdominal cavity)
- No known brain metastases
- Additional entry criteria to be discussed when you contact the study team
Principal Investigator
Contact
- Gina Mileo, RN
- 212-746-5430
- [email protected]
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Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Erica Bersin
Tel: (646) 962-8232
[email protected]