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



Status:Terminated
Conditions:Cancer, Cancer, Bladder Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 120
Updated:7/14/2018
Start Date:September 21, 2005
End Date:April 2012

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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

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.


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
We found this trial at
4
sites
101 E Wood St
Spartanburg, South Carolina 29303
(864) 560-6000
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Gibbs Cancer Center is a nationally...
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Spartanburg, SC
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86 Jonathan Lucas Street
Charleston, South Carolina 29425
(843) 792-0700
Hollings Cancer Center at Medical University of South Carolina Located at the Medical University of...
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Charleston, SC
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555 East Cheves Street
Florence, South Carolina 29506
843-777-2000
McLeod Regional Medical Center McLeod Health, a regional presence and predominant healthcare organization, is dedicated...
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Florence, SC
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Mount Pleasant, South Carolina 29464
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Mount Pleasant, SC
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