RATIONALE: Drugs used in chemotherapy, such as cisplatin, gemcitabine, and paclitaxel, 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 find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving cisplatin, bevacizumab, and gemcitabine followed by surgery, bevacizumab, and paclitaxel works in treating patients with locally advanced nonmetastatic bladder cancer that can be removed by surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Before surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 4 cycles After surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 3 cycles
Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles
Before surgery: given as a 1000mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle for 4 cycles
After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
McLeod Regional Medical Center
Florence, South Carolina, United States
Lowcountry Hematology and Oncology, PA
Mt. Pleasant, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Complete Remission Rate
Time frame: From day of first treatment until after cycle 3
Urinary Survivin Levels
Time frame: Baseline, week 6 and week 12
Urinary Cytogenitics
Time frame: baseline and week 12
Progression Free Survival
Time frame: from first treatment until time of progression or death, whichever comes first
Median Overall Surivial
Time frame: from first treatment until death
Percentage of Planned Dose Received
Time frame: from first treatment until end of week 12
Rate of Post-operative Complications
Time frame: from first treatment until up to 48 hours after surgery.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.