Cisplatin, Gemcitabine Hydrochloride, and Sorafenib Tosylate in Treating Patients With Transitional Cell Cancer of the Bladder
Recruitment status was: Recruiting
RATIONALE: Drugs used in chemotherapy, such as cisplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Giving cisplatin and gemcitabine hydrochloride together with sorafenib tosylate may kill more tumor cells. Giving them before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving cisplatin and gemcitabine hydrochloride together with sorafenib tosylate works in treating patients with node-negative transitional cell cancer of the bladder.
Drug: gemcitabine hydrochloride
Drug: sorafenib tosylate
Other: imaging biomarker analysis
Other: laboratory biomarker analysis
Procedure: computed tomography
Procedure: neoadjuvant therapy
Radiation: fludeoxyglucose F 18
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Neoadjuvant Cisplatin and Gemcitabine Plus Sorafenib for Patients With Transitional-Cell Carcinoma of the Bladder|
- Pathological complete response [ Designated as safety issue: No ]
- Safety and tolerability [ Designated as safety issue: Yes ]
- Potential biological correlates of disease response and drug activity in tumor tissue samples before and after therapy [ Designated as safety issue: No ]
- Correlation between 18FDG-PET and standard CT results [ Designated as safety issue: No ]
|Study Start Date:||October 2010|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
- 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 survival).
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 studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01222676
|Fondazione Istituto Nazionale dei Tumori|
|Milan, Italy, 20133|
|Principal Investigator:||Roberto Salvioni, MD||Fondazione IRCCS Istituto Nazionale dei Tumori, Milano|