Bladder Cancer Clinical Trial
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
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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed transitional cell cancer (TCC) of the bladder
Staged as follows:
Muscle invasive (T2-T4a)
Node negative (N0)
No histologically or cytologically proven lymph node metastases
Nonmetastatic (M0)
No evidence of distant metastases
Resectable disease
Able to begin protocol treatment within 6 weeks after transurethral resection and cystoscopic evaluation
No central nervous system or brain metastases
PATIENT CHARACTERISTICS:
ECOG performance status of 0-2
Karnofsky 60-100%
White blood cell count ≥ 3,000/mm^3
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
AST(SGOT) and ALT(SGPT) ≤ 2 times upper limit of normal
Bilirubin ≤1.5 mg/dL
Creatinine clearance ≥ 60 mL/min
Urine protein/creatinine ratio < 1.0
Blood pressure ≤150/100 mm Hg
No prohibitive medical risks for chemotherapy
No history of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin, gemcitabine hydrochloride, or paclitaxel
No unstable angina
No history of myocardial infarction within the past 6 months
No cardiac arrhythmias
No New York Heart Association (NYHA) congestive heart failure ≥ grade 2
No history of stroke within the past 6 months
No clinically significant peripheral vascular disease
No evidence of bleeding diathesis or coagulopathy
No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
No serious nonhealing wound, ulcer, or bone fracture
No psychiatric illness or other psychosocial situation that would limit ability to comply with study and/or follow-up procedures
Not pregnant or nursing
Negative pregnancy test
Fertile patients must agree to use adequate contraception prior to study entry and for the duration of study participation
No significant traumatic injury with in the past 28 days
PRIOR CONCURRENT THERAPY:
No prior systemic chemotherapy
No prior pelvic radiation therapy
More than 4 weeks since prior participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
No concurrent participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
No major surgical procedure or open biopsy within the past 28 days
No anticipation of need for major surgical procedure during the course of the study
No minor surgical procedures, fine-needle aspirations, or core biopsies within the past 7 days
No concurrent treatment with hormones or other chemotherapeutic agents except the following:
Steroids given for adrenal failure
Hormones administered for nondisease-related conditions (e.g., insulin for diabetes)
Intermittent use of dexamethasone as an antiemetic in solid tumor protocols
No other concurrent investigational or commercial agents or therapies
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There are 4 Locations for this study
Charleston South Carolina, 29425, United States
Florence South Carolina, 29501, United States
Mount Pleasant South Carolina, 29464, United States
Spartanburg South Carolina, 29303, United States
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