Cisplatin, Bevacizumab, and Gemcitabine Followed by Surgery, Bevacizumab, and Paclitaxel in Treating Patients With Locally Advanced Nonmetastatic Bladder Cancer That Can Be Removed By Surgery

Phase 2

Terminated

Interventions: Biological: bevacizumab
Drug: cisplatin
Drug: gemcitabine hydrochloride
Drug: paclitaxel
Procedure: cysectomy

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
study intervention	gemcitabine hydrochloride	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.
study intervention	bevacizumab	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.
study intervention	cysectomy	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.
study intervention	cisplatin	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.
study intervention	paclitaxel	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.

Primary Outcome Measures

Name	Time	Method
Complete Remission Rate	From day of first treatment until after cycle 3

Secondary Outcome Measures

Name	Time	Method
Urinary Cytogenitics	baseline and week 12
Progression Free Survival	from first treatment until time of progression or death, whichever comes first
Rate of Post-operative Complications	from first treatment until up to 48 hours after surgery.
Median Overall Surivial	from first treatment until death
Percentage of Planned Dose Received	from first treatment until end of week 12
Urinary Survivin Levels	Baseline, week 6 and week 12

Locations (4): Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
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Spartanburg, South Carolina, United States
Hollings Cancer Center at Medical University of South Carolina
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Charleston, South Carolina, United States
McLeod Regional Medical Center
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Florence, South Carolina, United States
Lowcountry Hematology and Oncology, PA
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Mount Pleasant, South Carolina, United States