Clinical Trials

Sponsor(s): National Cancer Institute (NCI), Cancer and Leukemia Group B

Condition(s):

Bladder Cancer
Cancer of the ureter
Cystocele
Kidney Cancer
Prostate Cancer
Renal Cell Carcinoma
Cancer
Kidney Disease
Bladder Disorders
Metastatic Cancer
Neoplasms
Nephropathy
Pelvic Cancer

Purpose: RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, 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 block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether gemcitabine hydrochloride and cisplatin are more effective when given together with or without bevacizumab in treating patients with urinary tract cancer. PURPOSE: This randomized phase III trial is studying gemcitabine hydrochloride, cisplatin, and bevacizumab to see how well they work compared with gemcitabine hydrochloride, cisplatin, and placebo in treating patients with advanced urinary tract cancer.

Eligibility:

Minimum Age:

18 Years

Accepts Healthy Volunteers:

No

DISEASE CHARACTERISTICS:

- Histologically confirmed transitional cell carcinoma of the urinary tract (renal
pelvis, ureter, bladder, prostate, or urethra)

- Unresectable or progressive metastatic or locally advanced disease (T4b, N2, N3
or M1)

- Not a candidate for potentially curative surgery or radiotherapy

- No history of peritoneal carcinomatosis

- No known brain metastases

PATIENT CHARACTERISTICS:

- ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100%

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Bilirubin ≤ 1.25 times upper limit of normal (ULN) (≤ 2.5 times ULN for patient's
with Gilbert's disease)

- AST ≤ 2.0 times ULN

- Creatinine clearance ≥ 60 mL/min

- Urine protein:creatinine ratio < 1.0 OR urine protein ≤ 1+

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for up to 3 months after
completion of study treatment

- No NYHA class II-IV congestive heart failure

- History of hypertension allowed provided it is well controlled (i.e., BP < 150/90 mm
Hg) on a regimen of anti-hypertensive therapy

- No arterial thrombotic events within the past 6 months, including any of the
following:

- Transient ischemic attack

- Cerebrovascular accident

- Peripheral arterial thrombus

- Unstable angina or angina requiring surgical or medical intervention

- Myocardial infarction

- No clinically significant peripheral artery disease (i.e., claudication on < one
block)

- Deep venous thrombosis or pulmonary embolus within the past 6 months allowed provided
patient is on stable therapeutic anticoagulation

- No significant bleeding events (e.g., hemoptysis, upper or lower gastrointestinal
[GI] bleeding, or grade 3 or 4 gross hematuria uncontrolled by transurethral
resection of the bladder tumor) within the past 6 months

- No GI perforation within the past 12 months

- No serious or non-healing wound, ulcer, or bone fracture

- No sensory or motor peripheral neuropathy ≥ grade 2

- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant
human antibodies

PRIOR CONCURRENT THERAPY:

- At least 4 weeks since prior radiotherapy (including palliative radiotherapy) or
major surgery and recovered

- At least 4 weeks since prior intravesical therapy

- No prior combination systemic chemotherapy for metastatic disease

- Single-agent radiosensitizing chemotherapy is not considered prior systemic
therapy

- Prior neoadjuvant or adjuvant systemic chemotherapy allowed provided it was
completed ≥ 1 year prior to the diagnosis of metastatic disease

- No prior bevacizumab or other angiogenesis inhibitors

- No concurrent radiotherapy (including palliative radiotherapy)

- Concurrent full-dose anticoagulants allowed provided patient is on a stable dose of
warfarin and has an in-range INR (between 2 and 3) OR is on a stable dose of low
molecular weight heparin

- Concurrent anti-platelet agents, daily prophylactic aspirin, or anticoagulation
agents for atrial fibrillation allowed

Other Location(s): Mobile, Alabama United States,Norwich, Connecticut United States,Newark, Delaware United States,Lewes, Delaware United States,Orlando, Florida United States,Gainesville, Georgia United States,Decatur, Illinois United States,Mt. Vernon, Illinois United States,Alton, Illinois United States,Rockford, Illinois United States,Chicago, Illinois United States,Fort Wayne, Indiana United States,Des Moines, Iowa United States,Iowa City, Iowa United States,Des Moines, Iowa United States,Des Moines, Iowa United States,Ottumwa, Iowa United States,Ames, Iowa United States,Clive, Iowa United States,Des Moines, Iowa United States,Des Moines, Iowa United States,Des Moines, Iowa United States,Sioux City, Iowa United States,Sioux City, Iowa United States,Sioux City, Iowa United States,Wichita, Kansas United States,Fort Scott, Kansas United States,Kingman, Kansas United States,Wichita, Kansas United States,Chanute, Kansas United States,Dodge City, Kansas United States,El Dorado, Kansas United States,Wichita, Kansas United States,Newton, Kansas United States,Parsons, Kansas United States,Pratt, Kansas United States,Salina, Kansas United States,Wellington, Kansas United States,Winfield, Kansas United States,Independence, Kansas United States,Wichita, Kansas United States,Lawrence, Kansas United States,Overland Park, Kansas United States,Overland Park, Kansas United States,Shawnee Mission, Kansas United States,Liberal, Kansas United States,Wichita, Kansas United States,Elkton Md, Maryland United States,Iron Mountain, Michigan United States,Escanaba, Michigan United States,Bemidji, Minnesota United States,Saint Louis, Missouri United States,Springfield, Missouri United States,Kansas City, Missouri United States,Saint Louis, Missouri United States,Saint Louis, Missouri United States,Saint Joseph, Missouri United States,Springfield, Missouri United States,Liberty, Missouri United States,Saint Louis, Missouri United States,Saint Louis, Missouri United States,Kansas City, Missouri United States,Kansas City, Missouri United States,Kansas City, Missouri United States,Cape Girardeau, Missouri United States,Kansas City, Missouri United States,Lee's Summit, Missouri United States,Saint Louis, Missouri United States,Springfield, Missouri United States,Kansas City, Missouri United States,Kansas City, Missouri United States,Great Falls, Montana United States,Billings, Montana United States,Bozeman, Montana United States,Billings, Montana United States,Missoula, Montana United States,Kalispell, Montana United States,Great Falls, Montana United States,Missoula, Montana United States,Billings, Montana United States,Kalispell, Montana United States,Kalispell, Montana United States,Great Falls, Montana United States,Missoula, Montana United States,Missoula, Montana United States,Havre, Montana United States,Billings, Montana United States,Great Falls, Montana United States,Butte, Montana United States,Helena, Montana United States,Billings, Montana United States,Omaha, Nebraska United States,Omaha, Nebraska United States,Omaha, Nebraska United States,Omaha, Nebraska United States,Omaha, Nebraska United States,Voorhees, New Jersey United States,Voorhees, New Jersey United States,Marlton, New Jersey United States,East Syracuse, New York United States,Glens Falls, New York United States,Middletown, New York United States,Reidsville, North Carolina United States,Kinston, North Carolina United States,Greensboro, North Carolina United States,Hendersonville, North Carolina United States,Asheboro, North Carolina United States,Goldsboro, North Carolina United States,Bismarck, North Dakota United States,Fargo, North Dakota United States,Bismarck, North Dakota United States,Fargo, North Dakota United States,Bismarck, North Dakota United States,Bismarck, North Dakota United States,Chillicothe, Ohio United States,Columbus, Ohio United States,Springfield, Ohio United States,Columbus, Ohio United States,Lancaster, Ohio United States,Zanesville, Ohio United States,Delaware, Ohio United States,Columbus, Ohio United States,Newark, Ohio United States,Bellefontaine, Ohio United States,Canton, Ohio United States,Springfield, Ohio United States,Columbus, Ohio United States,Westerville, Ohio United States,Columbus, Ohio United States,Lima, Ohio United States,Marietta, Ohio United States,Lawton, Oklahoma United States,Wilkes-Barre, Pennsylvania United States,Danville, Pennsylvania United States,Hazleton, Pennsylvania United States,State College, Pennsylvania United States,Sioux Falls, South Dakota United States,Sioux Falls, South Dakota United States,Sioux Falls, South Dakota United States,Kingsport, Tennessee United States,Danville, Virginia United States,Martinsville, Virginia United States,Norton, Virginia United States,Richmond, Virginia United States,Marinette, Wisconsin United States,Appleton, Wisconsin United States,Oconto Falls, Wisconsin United States,Sturgeon Bay, Wisconsin United States,Green Bay, Wisconsin United States,Green Bay, Wisconsin United States,La Crosse, Wisconsin United States,Manitowoc, Wisconsin United States,Green Bay, Wisconsin United States,Green Bay, Wisconsin United States,Casper, Wyoming United States,Sheridan, Wyoming United States

Terms: This is an abstract courtesy of ClinicalTrials.gov, a service of the US National Institute of Health Developed by the National Library of Medicine. ClinicalTrials.gov provides regularly updates information about federally and privately supported clinical research in human volunteers.