A Phase II Study of Neo-Adjuvant Cisplatin, Gemcitabine & Bevacizumab, Followed by Radical Cystectomy for Patients With Muscle Invasive, Resectable, Non-Metastatic Transitional Cell Carcinoma (TCC) of the Bladder

Inclusion 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