A Phase II Study of Neoadjuvant Cisplatin and Gemcitabine Plus Sorafenib for Patients With Transitional-Cell Carcinoma of the Bladder
- To evaluate the activity (pathological complete response) of neoadjuvant cisplatin and
gemcitabine hydrochloride in combination with sorafenib tosylate in patients with
muscle-invasive, node-negative transitional cell carcinoma of the bladder.
- To evaluate the safety and tolerability of this regimen in these patients.
- To determine the potential biological correlates of disease response and drug activity
in tumor tissue samples before and after treatment.
- To evaluate the correlation between fludeoxyglucose F 18 positron emission tomography
(18FDG-PET) and standard computed tomography (CT) results and the ability of changes of
18FDG-PET (as measured by EORTC criteria for response) to predict subsequent favorable
response to treatment (pathological complete response rate and progression-free
OUTLINE: Patients receive cisplatin IV over 20-30 minutes on day 1 and gemcitabine
hydrochloride IV over 30 minutes on days 1 and 8. Patients also receive sorafenib tosylate
twice daily on days 1-21. starting on day 1and continuing up to Treatment repeats every 21
days for 2 courses. Patients are reassessed after course 2, those who experience disease
progression or deemed unresectable are off study. Other patients continue the treatment for
2 more courses*.
NOTE: *Sorafenib tosylate are stopped 14 days prior to planned cystectomy.
No more than 30 days after completion of neoadjuvant therapy, patients undergo planned
radical cystectomy with pelvic lymph-node dissection off study.
Tumor tissue and serum samples may be collected during study for additional biological
Masking: Open Label, Primary Purpose: Treatment
Pathological complete response
Roberto Salvioni, MD
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano