CTSU C90601: A Randomized Doubled-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients with Advanced Transitional Cell Carcinoma
- Type of Study
- Cancer (Oncology) - Renal
- Swedish Cancer Institute
- Short Description
Purpose: This randomized phase III trial is studying 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.
- Open to Enrollment
- Principal Investigator
- Gary Goodman, M.D.
- Eligibility Notes
- Histologically confirmed transitional cell carcinoma of the urinary tract (renal pelvis, ureter, bladder, prostate or urethra)
- Unresectable or progressive metastatic or locally advanced disease (T4b, N2, N3 or M1)
- Not a candidate for potentially curative surgery or radiotherapy
- No history of peritoneal carcinomatosis
- At least 4 weeks since prior radiotherapy (including palliative radiotherapy) or major surgery and recovered
- At least 4 weeeks since prior intravesical therapy
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
- More Info Link
- Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
- (206) 215-3086