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
Bladder Cancer
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring transitional cell carcinoma of the bladder, stage III bladder cancer, stage II bladder cancer, recurrent bladder cancer
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
Sites / Locations
- Hollings Cancer Center at Medical University of South Carolina
- McLeod Regional Medical Center
- Lowcountry Hematology and Oncology, PA
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Arms of the Study
Arm 1
Experimental
study intervention
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.