Gemcitabine Hydrochloride and Cisplatin With or Without Bevacizumab in Treating Patients With Advanced Urinary Tract Cancer
Advanced Urothelial Carcinoma, Metastatic Bladder Urothelial Carcinoma, Metastatic Prostate Carcinoma
About this trial
This is an interventional treatment trial for Advanced Urothelial Carcinoma
Eligibility Criteria
Inclusion Criteria:
Patients must have histologically or cytologically documented metastatic or unresectable transitional cell (urothelial) carcinoma of the urinary tract (renal pelvis, ureter, bladder, prostate, or urethra), with metastatic or locally advanced disease (T4b, N2, N3, or M1); patients must not be candidates for potentially curative surgery or radiotherapy
- For patients that have had surgical resection prior to study enrollment, residual or unresected disease (measurable and/or unmeasurable) must be evident on post-surgical scans
Prior treatment for transitional cell carcinoma (TCC)
- Patients may not have received combination systemic chemotherapy for metastatic disease
- For the purposes of this study, radiosensitizing single agent chemotherapy is not considered prior systemic therapy
- Prior neoadjuvant or adjuvant systemic chemotherapy is permissible provided the interval from end of therapy to diagnosis of metastatic disease is at least 1 year
- >= 4 weeks since any prior radiation (including palliative) or major surgery and fully recovered
- >= 7 days since any minor surgery such as port placement
- >= 4 weeks since any intravesical therapy
- No prior treatment with bevacizumab or other angiogenesis inhibitors
- No known history of brain metastases; brain imaging (magnetic resonance imaging [MRI]/computed tomography [CT]) is not required
- No current congestive heart failure; New York Heart Association (NYHA) class II, III or IV
- Patients with history of hypertension must be well controlled (< 150/90) on a regimen of anti-hypertensive therapy
- Patients on full-dose anticoagulants must be on a stable dose of warfarin and have an in-range international normalized ratio (INR) (usually between 2 and 3) or be on a stable dose of low molecular weight (LMW) heparin; patients receiving anti-platelet agents are also eligible; in addition, patients who are on daily prophylactic aspirin or anticoagulation for atrial fibrillation are eligible
No significant history of bleeding events or gastrointestinal (GI) perforation
- Patients with a history of a significant bleeding episode (e.g. hemoptysis, upper or lower GI bleeding, grade 3 or 4 gross hematuria unable to be controlled by trans-urethral resection of the bladder tumor) within 6 months of registration are not eligible
- Patients with a history of GI perforation within 12 months of registration are not eligible
- Patients with a history of peritoneal carcinomatosis are not eligible
- No arterial thrombotic events within 6 months of registration, including transient ischemic attack (TIA), cerebrovascular accident (CVA), peripheral arterial thrombus, unstable angina or angina requiring surgical or medical intervention in the past 6 months, or myocardial infarction (MI); patients with clinically significant peripheral artery disease (i.e., claudication on less than one block) are ineligible
- Patients who have experienced a deep venous thrombosis or pulmonary embolus within the past 6 months must be on stable therapeutic anticoagulation to be enrolled to this study
- No serious or non-healing wound, ulcer, or bone fracture
- No sensory or motor peripheral neuropathy >= grade 2
- Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies are not eligible
Patients that are pregnant or nursing are not eligible; women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours prior to registration
- For women of child-bearing potential with an elevated beta-HCG that is believed to be related to cancer and not pregnancy, a negative trans-vaginal ultrasound and gynecological examination are required
- Women of child-bearing potential include any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea >= 12 consecutive months; or women on hormone replacement therapy [HRT] with documented serum follicle stimulating hormone [FSH] level > 35 mIU/mL); even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (or Karnofsky performance status [KPS] >= 80)
- Absolute neutrophil count (ANC) >= 1,500/uL
- Platelet count >= 100,000/uL
- Calculated or measured creatinine clearance >= 50 mL/minute
- Bilirubin =< 1.25 times upper limits of normal; for patients with Gilbert's disease, =< 2.5 x upper limit of normal (ULN) is allowed
- Aspartate aminotransferase (AST) =< 2.0 x upper limits of normal
- Urine protein to creatinine ratio < 1.0 or urine protein =< 1+ or 24-hour urine protein =< 1 gram
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- Providence Hospital
- Fairbanks Memorial Hospital
- University of Arizona Cancer Center-Orange Grove Campus
- Banner University Medical Center - Tucson
- University of Arizona Cancer Center-North Campus
- Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
- John L McClellan Memorial Veterans Hospital
- University of Arkansas for Medical Sciences
- Alta Bates Summit Medical Center-Herrick Campus
- Mills-Peninsula Medical Center
- East Bay Radiation Oncology Center
- Valley Medical Oncology Consultants-Castro Valley
- Community Cancer Institute
- John Muir Medical Center-Concord Campus
- Bay Area Breast Surgeons Inc
- Epic Care Partners in Cancer Care
- Valley Medical Oncology Consultants-Fremont
- Marin Cancer Care Inc
- Marin General Hospital
- UC San Diego Moores Cancer Center
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- Contra Costa Regional Medical Center
- Memorial Medical Center
- El Camino Hospital
- Palo Alto Medical Foundation-Camino Division
- Northridge Hospital Medical Center
- Sutter Cancer Research Consortium
- Highland General Hospital
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Tumor Institute
- Hematology and Oncology Associates-Oakland
- Tom K Lee Inc
- Saint Joseph Hospital - Orange
- UC Irvine Health/Chao Family Comprehensive Cancer Center
- Palo Alto Medical Foundation Health Care
- Stanford Cancer Institute Palo Alto
- Keck Medical Center of USC Pasadena
- Valley Care Health System - Pleasanton
- Valley Medical Oncology Consultants
- Saint Helena Hospital
- Salinas Valley Memorial
- California Pacific Medical Center-Pacific Campus
- UCSF Medical Center-Mount Zion
- Doctors Medical Center- JC Robinson Regional Cancer Center
- Palo Alto Medical Foundation-Santa Cruz
- Sutter Pacific Medical Foundation
- Palo Alto Medical Foundation-Sunnyvale
- Sutter Solano Medical Center/Cancer Center
- John Muir Medical Center-Walnut Creek
- San Luis Valley Regional Medical Center
- Rocky Mountain Cancer Centers-Aurora
- The Medical Center of Aurora
- Rocky Mountain Regional VA Medical Center
- University of Colorado Hospital
- Boulder Community Hospital
- Rocky Mountain Cancer Centers-Boulder
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- Kaiser Permanente-Franklin
- Porter Adventist Hospital
- University of Colorado
- Colorado Blood Cancer Institute
- Presbyterian - Saint Lukes Medical Center - Health One
- Rocky Mountain Cancer Centers-Midtown
- SCL Health Saint Joseph Hospital
- Rocky Mountain Cancer Centers-Rose
- Rose Medical Center
- Western States Cancer Research NCORP
- Mercy Medical Center
- Southwest Oncology PC
- Shaw Cancer Center
- Mountain Blue Cancer Care Center - Swedish
- Swedish Medical Center
- Poudre Valley Hospital
- Valley View Hospital Cancer Center
- Mountain Blue Cancer Care Center
- Saint Mary's Hospital and Regional Medical Center
- North Colorado Medical Center
- Rocky Mountain Cancer Centers-Greenwood Village
- Kaiser Permanente-Rock Creek
- Rocky Mountain Cancer Centers-Lakewood
- Saint Anthony Hospital
- Rocky Mountain Cancer Centers-Littleton
- Littleton Adventist Hospital
- Kaiser Permanente-Lone Tree
- Rocky Mountain Cancer Centers-Sky Ridge
- Sky Ridge Medical Center
- Longmont United Hospital
- Rocky Mountain Cancer Centers-Longmont
- McKee Medical Center
- Montrose Memorial Hospital
- Parker Adventist Hospital
- Rocky Mountain Cancer Centers-Parker
- Saint Mary Corwin Medical Center
- Rocky Mountain Cancer Centers - Pueblo
- North Suburban Medical Center
- Rocky Mountain Cancer Centers-Thornton
- SCL Health Lutheran Medical Center
- Danbury Hospital
- University of Connecticut
- Greenwich Hospital
- Hartford Hospital
- Smilow Cancer Hospital Care Center at Saint Francis
- Manchester Memorial Hospital
- Midstate Medical Center
- Yale University
- Norwalk Hospital
- Eastern Connecticut Hematology and Oncology Associates
- Stamford Hospital/Bennett Cancer Center
- Beebe Medical Center
- Christiana Gynecologic Oncology LLC
- Delaware Clinical and Laboratory Physicians PA
- Helen F Graham Cancer Center
- Medical Oncology Hematology Consultants PA
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- TidalHealth Nanticoke / Allen Cancer Center
- Christiana Care Health System-Wilmington Hospital
- MedStar Georgetown University Hospital
- MedStar Washington Hospital Center
- Sibley Memorial Hospital
- AdventHealth Altamonte
- Holy Cross Hospital
- Jupiter Medical Center
- AdventHealth Kissimmee
- Mount Sinai Medical Center
- AdventHealth Medical Group Urology at Orlando
- AdventHealth Orlando
- Orlando Health Cancer Institute
- AdventHealth East Orlando
- Cleveland Clinic-Weston
- AdventHealth Winter Park
- Piedmont Hospital
- Atlanta Regional CCOP
- Emory Saint Joseph's Hospital
- Northside Hospital
- WellStar Cobb Hospital
- John B Amos Cancer Center
- Dekalb Medical Center
- Piedmont Fayette Hospital
- Northeast Georgia Medical Center-Gainesville
- Northside Hospital - Gwinnett
- Medical Center of Central Georgia
- Wellstar Kennestone Hospital
- Southern Regional Medical Center
- Harbin Clinic Medical Oncology and Clinical Research
- Memorial Health University Medical Center
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Pali Momi Medical Center
- Queen's Cancer Center - Pearlridge
- Hawaii Cancer Care Inc - Waterfront Plaza
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- Kuakini Medical Center
- Queen's Cancer Center - Kuakini
- Kapiolani Medical Center for Women and Children
- Castle Medical Center
- Wilcox Memorial Hospital and Kauai Medical Clinic
- Saint Alphonsus Cancer Care Center-Boise
- Saint Luke's Cancer Institute - Boise
- Saint Luke's Cancer Institute - Fruitland
- Saint Joseph Regional Medical Center
- Idaho Urologic Institute-Meridian
- Saint Luke's Cancer Institute - Meridian
- Saint Luke's Cancer Institute - Nampa
- Kootenai Clinic Cancer Services - Post Falls
- Saint Luke's Cancer Institute - Twin Falls
- Saint Anthony's Health
- Rush - Copley Medical Center
- Saint Joseph Medical Center
- Illinois CancerCare-Bloomington
- Graham Hospital Association
- Illinois CancerCare-Canton
- Memorial Hospital of Carbondale
- Illinois CancerCare-Carthage
- Memorial Hospital
- Centralia Oncology Clinic
- Hematology and Oncology Associates
- Northwestern University
- University of Chicago Comprehensive Cancer Center
- Carle on Vermilion
- Cancer Care Specialists of Illinois - Decatur
- Decatur Memorial Hospital
- Heartland Cancer Research NCORP
- Carle Physician Group-Effingham
- Crossroads Cancer Center
- Elmhurst Memorial Hospital
- Eureka Hospital
- Illinois CancerCare-Eureka
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- Northwestern Medicine Cancer Center Delnor
- Illinois CancerCare-Havana
- Mason District Hospital
- Hematology Oncology Associates of Illinois-Highland Park
- Edward Hines Jr VA Hospital
- Midwest Center for Hematology Oncology
- Presence Saint Mary's Hospital
- Illinois CancerCare-Kewanee Clinic
- AMITA Health Adventist Medical Center
- AMG Libertyville - Oncology
- Illinois CancerCare-Macomb
- Mcdonough District Hospital
- Carle Physician Group-Mattoon/Charleston
- Loyola University Medical Center
- Holy Family Medical Center
- Illinois CancerCare-Monmouth
- Good Samaritan Regional Health Center
- UC Comprehensive Cancer Center at Silver Cross
- Illinois Cancer Specialists-Niles
- Bromenn Regional Medical Center
- Carle Cancer Institute Normal
- Illinois CancerCare-Community Cancer Center
- Illinois CancerCare-Ottawa Clinic
- Ottawa Regional Hospital and Healthcare Center
- Radiation Oncology of Northern Illinois
- Illinois CancerCare-Pekin
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Proctor Hospital
- Illinois CancerCare-Peoria
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Illinois Valley Hospital
- Valley Radiation Oncology
- Illinois CancerCare-Princeton
- Perry Memorial Hospital
- Swedish American Hospital
- SwedishAmerican Regional Cancer Center/ACT
- Hematology Oncology Associates of Illinois - Skokie
- Illinois CancerCare-Spring Valley
- Memorial Medical Center
- Carle Cancer Center
- The Carle Foundation Hospital
- Northwestern Medicine Cancer Center Warrenville
- Rush-Copley Healthcare Center
- Franciscan Saint Francis Health-Beech Grove
- IU Health North Hospital
- Elkhart Clinic
- Michiana Hematology Oncology PC-Elkhart
- Elkhart General Hospital
- Fort Wayne Medical Oncology and Hematology Inc-Parkview
- Indiana University/Melvin and Bren Simon Cancer Center
- Richard L. Roudebush Veterans Affairs Medical Center
- Sidney and Lois Eskenazi Hospital
- Community Howard Regional Health
- IU Health La Porte Hospital
- IU Health Arnett Cancer Care
- Premier Oncology Hematology Associates
- Franciscan Saint Anthony Health-Michigan City
- Woodland Cancer Care Center
- Michiana Hematology Oncology PC-Mishawaka
- Saint Joseph Regional Medical Center-Mishawaka
- IU Health Ball Memorial Hospital
- Michiana Hematology Oncology PC-Plymouth
- Reid Health
- Memorial Hospital of South Bend
- Michiana Hematology Oncology PC-South Bend
- South Bend Clinic
- Northern Indiana Cancer Research Consortium
- Michiana Hematology Oncology PC-Westville
- Mary Greeley Medical Center
- McFarland Clinic PC - Ames
- University of Iowa Healthcare Cancer Services Quad Cities
- McFarland Clinic PC-Boone
- Physicians' Clinic of Iowa PC
- Saint Luke's Hospital
- Mercy Hospital
- Oncology Associates at Mercy Medical Center
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Alegent Health Mercy Hospital
- Mercy Capitol
- Iowa Methodist Medical Center
- Iowa-Wide Oncology Research Coalition NCORP
- Medical Oncology and Hematology Associates-Des Moines
- Medical Oncology and Hematology Associates-Laurel
- Mercy Medical Center - Des Moines
- Iowa Lutheran Hospital
- McFarland Clinic PC-Trinity Cancer Center
- University of Iowa/Holden Comprehensive Cancer Center
- Iowa City VA Healthcare System
- McFarland Clinic PC-Jefferson
- McFarland Clinic PC-Marshalltown
- Mercy Medical Center - North Iowa
- Ottumwa Regional Health Center
- Siouxland Regional Cancer Center
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- Methodist West Hospital
- Mercy Medical Center-West Lakes
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Newman Regional Health
- Cancer Center of Kansas - Fort Scott
- Saint Catherine Hospital
- Saint Rose Ambulatory and Surgery Center
- HaysMed University of Kansas Health System
- Hutchinson Regional Medical Center
- Cancer Center of Kansas-Independence
- Providence Medical Center
- University of Kansas Cancer Center-West
- University of Kansas Cancer Center
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas-Liberal
- Cancer Center of Kansas-Manhattan
- Cancer Center of Kansas - McPherson
- Cancer Center of Kansas - Newton
- Menorah Medical Center
- University of Kansas Cancer Center-Overland Park
- Saint Luke's South Hospital
- Cancer Center of Kansas - Parsons
- Ascension Via Christi - Pittsburg
- Kansas City NCI Community Oncology Research Program
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Salina Regional Health Center
- Advent Health - Shawnee Mission Medical Center
- University of Kansas Health System Saint Francis Campus
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Ascension Via Christi Hospitals Wichita
- Cancer Center of Kansas - Wichita
- Wesley Medical Center
- Wichita NCI Community Oncology Research Program
- Cancer Center of Kansas - Winfield
- Flaget Memorial Hospital
- Saint Joseph Radiation Oncology Resource Center
- Saint Joseph Hospital East
- University of Kentucky/Markey Cancer Center
- Jewish Hospital
- Doctors Carrol, Sheth, Raghavan
- Saints Mary and Elizabeth Hospital
- UofL Health Medical Center Northeast
- Owensboro Health Mitchell Memorial Cancer Center
- Jewish Hospital Medical Center South
- Baton Rouge General Medical Center
- Mary Bird Perkins Cancer Center
- Ochsner Health Center-Summa
- Robert Veith MD LLC
- Louisiana State University Health Science Center
- University Medical Center New Orleans
- Ochsner Medical Center Jefferson
- Harold Alfond Center for Cancer Care
- Eastern Maine Medical Center
- Maine Center for Cancer Medicine-Scarborough
- University of Maryland/Greenebaum Cancer Center
- Veterans Administration Medical Center-Baltimore
- Johns Hopkins University/Sidney Kimmel Cancer Center
- Christiana Care - Union Hospital
- Maryland Oncology Hematology PA-Aquilino Cancer Center
- Massachusetts General Hospital Cancer Center
- Brigham and Women's Hospital
- Beth Israel Deaconess Medical Center
- Dana-Farber Cancer Institute
- Steward Saint Elizabeth's Medical Center
- Holy Family Hospital
- Norwood Hospital
- Baystate Medical Center
- UMass Memorial Medical Center - University Campus
- Bixby Medical Center
- Hickman Cancer Center
- Michigan Cancer Research Consortium NCORP
- Saint Joseph Mercy Hospital
- Bronson Battle Creek
- Spectrum Health Big Rapids Hospital
- Beaumont Hospital - Dearborn
- Henry Ford Hospital
- Ascension Saint John Hospital
- Green Bay Oncology - Escanaba
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Genesys Regional Medical Center-West Flint Campus
- Cancer Research Consortium of West Michigan NCORP
- Mercy Health Saint Mary's
- Spectrum Health at Butterworth Campus
- Green Bay Oncology - Iron Mountain
- Allegiance Health
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- Sparrow Hospital
- Trinity Health Saint Mary Mercy Livonia Hospital
- UP Health System Marquette
- Mercy Memorial Hospital
- Toledo Clinic Cancer Centers-Monroe
- Mercy Health Mercy Campus
- Lakeland Hospital Niles
- Saint Joseph Mercy Oakland
- Lake Huron Medical Center
- Spectrum Health Reed City Hospital
- William Beaumont Hospital-Royal Oak
- Ascension Saint Mary's Hospital
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer Center
- Munson Medical Center
- Saint John Macomb-Oakland Hospital
- Medini, Eitan MD (UIA Investigator)
- Sanford Joe Lueken Cancer Center
- Fairview Ridges Hospital
- Mercy Hospital
- Essentia Health Cancer Center
- Essentia Health Saint Mary's Medical Center
- Miller-Dwan Hospital
- Fairview Southdale Hospital
- Lake Region Healthcare Corporation-Cancer Care
- Unity Hospital
- Hutchinson Area Health Care
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- Health Partners Inc
- University of Minnesota/Masonic Cancer Center
- New Ulm Medical Center
- North Memorial Medical Health Center
- Mayo Clinic in Rochester
- Coborn Cancer Center at Saint Cloud Hospital
- Saint Cloud Hospital
- Metro Minnesota Community Oncology Research Consortium
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Hattiesburg Clinic - Hematology/Oncology Clinic
- Forrest General Hospital / Cancer Center
- University of Mississippi Medical Center
- Central Care Cancer Center - Bolivar
- Parkland Health Center-Bonne Terre
- Cox Cancer Center Branson
- Saint Francis Medical Center
- Southeast Cancer Center
- Veterans Administration
- University of Missouri - Ellis Fischel
- Centerpoint Medical Center LLC
- Capital Region Southwest Campus
- Freeman Health System
- Mercy Hospital Joplin
- Truman Medical Centers
- Saint Luke's Hospital of Kansas City
- Saint Joseph Health Center
- North Kansas City Hospital
- Heartland Hematology and Oncology Associates Incorporated
- Kansas City Veterans Affairs Medical Center
- The University of Kansas Cancer Center-South
- Research Medical Center
- University of Kansas Cancer Center - North
- University of Kansas Cancer Center - Lee's Summit
- Saint Luke's East - Lee's Summit
- Liberty Radiation Oncology Center
- Delbert Day Cancer Institute at PCRMC
- Mercy Clinic-Rolla-Cancer and Hematology
- Heartland Regional Medical Center
- Saint Joseph Oncology Inc
- SSM Health Saint Louis University Hospital
- Saint Louis Cancer and Breast Institute-South City
- Washington University School of Medicine
- Missouri Baptist Medical Center
- Center for Cancer Care and Research
- Comprehensive Cancer Care PC
- Mercy Hospital Saint Louis
- Saint Louis-Cape Girardeau CCOP
- Sainte Genevieve County Memorial Hospital
- Cancer Research for the Ozarks NCORP
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Missouri Baptist Sullivan Hospital
- Missouri Baptist Outpatient Center-Sunset Hills
- Billings Clinic Cancer Center
- Northern Rockies Radiation Oncology Center
- Saint Vincent Healthcare
- Montana Cancer Consortium NCORP
- Saint Vincent Frontier Cancer Center
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Berdeaux, Donald MD (UIA Investigator)
- Great Falls Clinic
- Northern Montana Hospital
- Saint Peter's Community Hospital
- Glacier Oncology PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Montana Cancer Specialists
- Saint Patrick Hospital - Community Hospital
- Community Medical Hospital
- Guardian Oncology and Center for Wellness
- CHI Health Saint Francis
- Heartland Hematology and Oncology
- CHI Health Good Samaritan
- Nebraska Cancer Research Center
- Saint Elizabeth Regional Medical Center
- Great Plains Health Callahan Cancer Center
- Missouri Valley Cancer Consortium
- Nebraska Methodist Hospital
- Alegent Health Immanuel Medical Center
- Hematology and Oncology Consultants PC
- Alegent Health Bergan Mercy Medical Center
- Alegent Health Lakeside Hospital
- Creighton University Medical Center
- University of Nebraska Medical Center
- Midlands Community Hospital
- Cancer and Blood Specialists-Henderson
- Comprehensive Cancer Centers of Nevada - Henderson
- Las Vegas Cancer Center-Henderson
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
- GenesisCare USA - Henderson
- University Medical Center of Southern Nevada
- Cancer and Blood Specialists-Shadow
- Radiation Oncology Centers of Nevada Central
- GenesisCare USA - Las Vegas
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
- Radiation Oncology Centers of Nevada Southeast
- Cancer Therapy and Integrative Medicine
- Cancer and Blood Specialists-Tenaya
- Comprehensive Cancer Centers of Nevada - Northwest
- GenesisCare USA - Vegas Tenaya
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
- Nevada Cancer Institute-Summerlin Campus
- Comprehensive Cancer Centers of Nevada-Summerlin
- Summerlin Hospital Medical Center
- Las Vegas Cancer Center-Medical Center
- Comprehensive Cancer Centers of Nevada
- GenesisCare USA - Fort Apache
- OptumCare Cancer Care at Fort Apache
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
- Comprehensive Cancer Centers of Nevada - Central Valley
- Nevada Cancer Research Foundation NCORP
- New Hampshire Oncology Hematology PA-Concord
- LRGHealthcare-Lakes Region General Hospital
- Dartmouth Hitchcock Medical Center
- The Dana-Farber Cancer Institute at Londonderry
- Solinsky Center for Cancer Care
- Memorial Sloan Kettering Basking Ridge
- Cooper Hospital University Medical Center
- Veterans Adminstration New Jersey Health Care System
- Hackensack University Medical Center
- Morristown Medical Center
- Virtua Memorial
- Rutgers New Jersey Medical School
- Capital Health Medical Center-Hopewell
- Robert Wood Johnson University Hospital Somerset
- Overlook Hospital
- Inspira Medical Center Vineland
- MD Anderson Cancer Center at Cooper-Voorhees
- Virtua Voorhees
- University of New Mexico Cancer Center
- Hematology Oncology Associates of Central New York-Auburn
- Veteran Affairs New York Harbor Healthcare System-Brooklyn Campus
- Veterans Affairs Western New York Health Care System-Buffalo
- Roswell Park Cancer Institute
- Memorial Sloan Kettering Commack
- Hematology Oncology Associates of Central New York-East Syracuse
- Glens Falls Hospital
- Garnet Health Medical Center
- Mount Sinai Union Square
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
- Mount Sinai West
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
- Memorial Sloan Kettering Cancer Center
- NYP/Weill Cornell Medical Center
- Interlakes Foundation Inc-Rochester
- University of Rochester
- Memorial Sloan Kettering Sleepy Hollow
- Staten Island University Hospital
- State University of New York Upstate Medical University
- Hematology Oncology Associates of Central New York-Onondaga Hill
- Memorial Sloan Kettering Nassau
- Randolph Hospital
- UNC Lineberger Comprehensive Cancer Center
- Carolinas Medical Center/Levine Cancer Institute
- Novant Health Presbyterian Medical Center
- Southeastern Medical Oncology Center-Clinton
- Atrium Health Cabarrus/LCI-Concord
- Duke University Medical Center
- Southeastern Medical Oncology Center-Goldsboro
- Wayne Memorial Hospital
- Cone Health Cancer Center
- East Carolina University
- Hendersonville Hematology and Oncology at Pardee
- Margaret R Pardee Memorial Hospital
- AdventHealth Hendersonville
- High Point Regional Hospital
- Southeastern Medical Oncology Center-Jacksonville
- Vidant Oncology-Kinston
- Southeastern Regional Medical Center
- Atrium Health Union/LCI-Union
- Granville Medical Center
- FirstHealth of the Carolinas-Moore Regional Hospital
- Duke Raleigh Hospital
- Annie Penn Memorial Hospital
- Person Memorial Hospital
- Rutherford Hospital
- Atrium Health Cleveland/LCI-Cleveland
- Iredell Memorial Hospital
- Southeast Clinical Oncology Research Consortium NCORP
- Wake Forest University Health Sciences
- Mid Dakota Clinic
- Saint Alexius Medical Center
- Sanford Bismarck Medical Center
- Sanford Broadway Medical Center
- Sanford Clinic North-Fargo
- Sanford Roger Maris Cancer Center
- Cleveland Clinic Akron General
- Cleveland Clinic Cancer Center Beachwood
- UHHS-Chagrin Highlands Medical Center
- Mary Rutan Hospital
- Strecker Cancer Center-Belpre
- Toledo Clinic Cancer Centers-Bowling Green
- Cleveland Clinic Mercy Hospital
- Aultman Health Foundation
- Geauga Hospital
- Adena Regional Medical Center
- University of Cincinnati Cancer Center-UC Medical Center
- Good Samaritan Hospital - Cincinnati
- Bethesda North Hospital
- TriHealth Cancer Institute-Westside
- TriHealth Cancer Institute-Anderson
- Case Western Reserve University
- MetroHealth Medical Center
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- North Coast Cancer Care-Clyde
- Ohio State University Comprehensive Cancer Center
- Mount Carmel East Hospital
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist Hospital
- Columbus NCI Community Oncology Research Program
- Grant Medical Center
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Doctors Hospital
- Grandview Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Miami Valley Hospital North
- Dayton Veterans Affairs Medical Center
- Delaware Health Center-Grady Cancer Center
- Delaware Radiation Oncology
- Grady Memorial Hospital
- Hematology Oncology Center Incorporated
- Mercy Cancer Center-Elyria
- Blanchard Valley Hospital
- Atrium Medical Center-Middletown Regional Hospital
- Wayne Hospital
- Cleveland Clinic Cancer Center Independence
- Kettering Medical Center
- Fairfield Medical Center
- Lancaster Radiation Oncology
- Saint Rita's Medical Center
- Lima Memorial Hospital
- Marietta Memorial Hospital
- Saint Luke's Hospital
- Toledo Clinic Cancer Centers-Maumee
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
- Hillcrest Hospital Cancer Center
- UH Seidman Cancer Center at Landerbrook Health Center
- UH Seidman Cancer Center at Lake Health Mentor Campus
- UH Seidman Cancer Center at Southwest General Hospital
- Knox Community Hospital
- Licking Memorial Hospital
- Newark Radiation Oncology
- Fisher-Titus Medical Center
- Saint Charles Hospital
- Toledo Clinic Cancer Centers-Oregon
- University Hospitals Parma Medical Center
- Southern Ohio Medical Center
- North Coast Cancer Care
- UH Seidman Cancer Center at Firelands Regional Medical Center
- Springfield Regional Medical Center
- Cleveland Clinic Cancer Center Strongsville
- ProMedica Flower Hospital
- Mercy Hospital of Tiffin
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
- Saint Vincent Mercy Medical Center
- University of Toledo
- Toledo Community Hospital Oncology Program CCOP
- Mercy Health - Saint Anne Hospital
- Toledo Clinic Cancer Centers-Toledo
- Upper Valley Medical Center
- Fulton County Health Center
- Saint Ann's Hospital
- UH Seidman Cancer Center at Saint John Medical Center
- UHHS-Westlake Medical Center
- Clinton Memorial Hospital
- Cleveland Clinic Wooster Family Health and Surgery Center
- Greene Memorial Hospital
- Genesis Healthcare System Cancer Care Center
- Cancer Centers of Southwest Oklahoma Research
- Cancer Care Associates-Norman
- University of Oklahoma Health Sciences Center
- Mercy Physicians of Oklahoma-Lakeside
- Natalie Warren Bryant Cancer Center at Saint Francis
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Warren Clinic Oncology-Tulsa
- Good Samaritan Hospital
- Jefferson Abington Hospital
- Lehigh Valley Hospital-Cedar Crest
- Lehigh Valley Hospital - Muhlenberg
- Butler Memorial Hospital
- Geisinger Medical Center
- Doylestown Hospital
- Geisinger Medical Center-Cancer Center Hazleton
- Geisinger Medical Oncology-Lewisburg
- Lewistown Hospital
- Pennsylvania Hospital
- Fox Chase Cancer Center
- Jefferson Torresdale Hospital
- Pottstown Hospital
- Geisinger Cancer Services-Pottsville
- Guthrie Medical Group PC-Robert Packer Hospital
- Geisinger Medical Group
- Reading Hospital
- Geisinger Wyoming Valley/Henry Cancer Center
- UPMC Susquehanna
- AnMed Health Cancer Center
- AnMed Health Hospital
- Prisma Health Cancer Institute - Spartanburg
- Roper Hospital
- Charleston Oncology - Roper
- Lowcountry Hematology Oncology PA-North Charleston
- Charleston Oncology - Saint Francis
- Lowcountry Hematology Oncology PA-West Ashley
- Medical University of South Carolina
- Prisma Health Cancer Institute - Easley
- Greenville Health System Cancer Institute-Andrews
- Saint Francis Hospital
- Prisma Health Cancer Institute - Butternut
- Prisma Health Cancer Institute - Faris
- Prisma Health Greenville Memorial Hospital
- Prisma Health Cancer Institute - Eastside
- Self Regional Healthcare
- Prisma Health Cancer Institute - Greer
- Gibbs Cancer Center-Pelham
- Carolina Blood and Cancer Care Associates PA-Lancaster
- Lowcountry Hematology Oncology PA-Mount Pleasant
- Carolina Blood and Cancer Care Associates PA
- Prisma Health Cancer Institute - Seneca
- Spartanburg Medical Center
- Sanford Cancer Center Oncology Clinic
- Avera Cancer Institute
- Medical X-Ray Center
- Sanford USD Medical Center - Sioux Falls
- Wellmont Medical Associates Oncology and Hematology-Bristol
- Erlanger Medical Center
- Memorial Hospital
- Pulmonary Medicine Center of Chattanooga-Hixson
- Ballad Health Cancer Care - Kingsport
- Wellmont Holston Valley Hospital and Medical Center
- Memorial GYN Plus
- UT Southwestern/Simmons Cancer Center-Dallas
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
- Baylor Saint Luke's Medical Center
- Ben Taub General Hospital
- Houston Methodist Hospital
- Michael E DeBakey VA Medical Center
- Southwestern Vermont Medical Center
- Central Vermont Medical Center/National Life Cancer Treatment
- University of Vermont and State Agricultural College
- Danville Regional Medical Center
- Fredericksburg Oncology Inc
- Hematology Oncology Associates of Fredericksburg Inc
- Centra Lynchburg Hematology-Oncology Clinic Inc
- Sovah Health Martinsville
- Southwest VA Regional Cancer Center
- Virginia Commonwealth University/Massey Cancer Center
- Cancer Care Center at Island Hospital
- MultiCare Auburn Medical Center
- Overlake Medical Center
- PeaceHealth Saint Joseph Medical Center
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Highline Medical Center-Main Campus
- Providence Regional Cancer System-Centralia
- Swedish Cancer Institute-Edmonds
- Saint Elizabeth Hospital
- Providence Regional Cancer Partnership
- Saint Francis Hospital
- Swedish Cancer Institute-Issaquah
- Kadlec Clinic Hematology and Oncology
- EvergreenHealth Medical Center
- Seattle Cancer Care Alliance at EvergreenHealth
- Providence Regional Cancer System-Lacey
- Saint Clare Hospital
- Skagit Valley Hospital
- Providence - Saint Peter Hospital
- Capital Medical Center
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- MultiCare Good Samaritan Hospital
- Virginia Mason Medical Center
- Harborview Medical Center
- Minor and James Medical PLLC
- Pacific Medical Center-First Hill
- Swedish Medical Center-Ballard Campus
- Fred Hutchinson Cancer Research Center
- Kaiser Permanente Washington
- Swedish Medical Center-First Hill
- University of Washington Medical Center - Montlake
- PeaceHealth United General Medical Center
- Cancer Care Northwest - Spokane South
- Evergreen Hematology and Oncology PS
- Rockwood Clinic
- Franciscan Research Center-Northwest Medical Plaza
- MultiCare Allenmore Hospital
- MultiCare Tacoma General Hospital
- Northwest Medical Specialties PLLC
- Northwest NCI Community Oncology Research Program
- Saint Joseph Medical Center
- Madigan Army Medical Center
- Wenatchee Valley Hospital and Clinics
- West Virginia University Charleston Division
- Edwards Comprehensive Cancer Center
- West Virginia University Healthcare
- Langlade Hospital and Cancer Center
- Aurora Cancer Care-Southern Lakes VLCC
- Marshfield Clinic-Chippewa Center
- Marshfield Clinic Cancer Center at Sacred Heart
- Aurora Health Care Germantown Health Center
- Aurora Cancer Care-Grafton
- Green Bay Oncology at Saint Vincent Hospital
- Saint Vincent Hospital Cancer Center Green Bay
- Green Bay Oncology Limited at Saint Mary's Hospital
- Saint Vincent Hospital Cancer Center at Saint Mary's
- Aurora BayCare Medical Center
- UW Cancer Center Johnson Creek
- Aurora Cancer Care-Kenosha South
- Gundersen Lutheran Medical Center
- University of Wisconsin Carbone Cancer Center
- Holy Family Memorial Hospital
- Aurora Bay Area Medical Group-Marinette
- Bay Area Medical Center
- Marshfield Medical Center-Marshfield
- Aurora Cancer Care-Milwaukee
- Aurora Saint Luke's Medical Center
- Medical College of Wisconsin
- Aurora Sinai Medical Center
- Marshfield Clinic-Minocqua Center
- Cancer Center of Western Wisconsin
- Saint Vincent Hospital Cancer Center at Oconto Falls
- Vince Lombardi Cancer Clinic - Oshkosh
- Aurora Cancer Care-Racine
- Ascension Saint Mary's Hospital
- Marshfield Medical Center-Rice Lake
- HSHS Saint Nicholas Hospital
- Vince Lombardi Cancer Clinic-Sheboygan
- Ascension Saint Michael's Hospital
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
- Green Bay Oncology - Sturgeon Bay
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic-Two Rivers
- Aurora Cancer Care-Waukesha
- Aspirus Regional Cancer Center
- Marshfield Clinic-Wausau Center
- Aurora Cancer Care-Milwaukee West
- Aurora West Allis Medical Center
- Marshfield Medical Center - Weston
- Marshfield Clinic - Wisconsin Rapids Center
- Rocky Mountain Oncology
- Cheyenne Regional Medical Center-West
- Welch Cancer Center
- San Juan City Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm I (gemcitabine hydrochloride, cisplatin, placebo)
Arm II (gemcitabine hydrochloride, cisplatin, bevacizumab)
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.