Conditions: Bladder Cancer
Keywords: transitional cell carcinoma of the bladder stage III bladder cancer stage II bladder cancer recurrent bladder cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 21
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Neo-adjuvant cisplatin, gemcitabine and bevacizumab followed by radical cystectomy. Patients without residual disease will enter follow up after surgery. Patients with residual disease will receive adjuvant therapy with bevacizumab and ciaplatin.

Interventions: intervention 1: bevacizumab intervention 2: cisplatin intervention 3: gemcitabine hydrochloride intervention 4: paclitaxel intervention 5: cysectomy
Intervention descriptions: intervention 1: 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 intervention 2: Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles intervention 3: Before surgery: given as a 1000mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle for 4 cycles intervention 4: After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles intervention 5: None

Protocol document: