A Phase II Study of Gemcitabine Plus Cisplatin Chemotherapy in Patients With Muscle-invasive Bladder Cancer With Bladder Preservation for Those Patients Whose Tumors Harbor Deleterious DNA Damage Response (DDR) Gene Alterations

Who is this study for? Adult patients with Muscle-Invasive Urothelial Carcinoma of the Bladder with no prior radiation therapy
Status: Recruiting
Location: See all (423) locations...
Intervention Type: Procedure, Drug, Biological, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This phase II trial studies how well gemcitabine hydrochloride and cisplatin work in treating participants with invasive bladder urothelial cancer. 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, by stopping them from dividing, or by stopping them from spreading.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Step 1 Patient Registration Eligibility Criteria

• Histologically confirmed muscle-invasive urothelial carcinoma of the bladder. Urothelial carcinoma invading into the prostatic stroma with no histologic muscle invasion is allowed, provided the extent of disease is confirmed via imaging and/or examination under anesthesia (EUA). The diagnostic TURBT sample must have been obtained within 60 days prior to registration

• 20 unstained slides (10 micron thickness) of formalin-fixed paraffin-embedded (FFPE) pre-treatment diagnostic transurethral resection (TUR) specimen available (for sequencing), with 2 (5 micron) slides at the start and end of the 20 slides, for a total of 22 unstained slides. An FFPE block is also acceptable

• Clinical stage T2-T4aN0/xM0 disease

• Medically appropriate candidate for radical cystectomy as assessed by surgeon

• No concomitant multifocal carcinoma in situ; a single focus is allowed

• A single muscle-invasive bladder tumor measuring ≤5 cm in size as defined by the surgeons at cystoscopic evaluation. When documented, pathologic size at cystoscopy and TURBT will take precedence over radiographic measurements of tumor size.

• No clinical or radiographic evidence for locally advanced or metastatic disease

• No prior anti-PD-1 or anti PD-L1 therapies, or systemic chemotherapy within the past 5 years (prior intravesical induction immunotherapy for non-muscle invasive disease is allowed, defined as BCG x6 doses and maintenance therapy); BCG refractory disease, defined as disease recurrence within 3 months of BCG therapy, is not allowed. Intravesical chemotherapy is allowed.

• No prior radiation therapy to the bladder or prostate

• No major surgery or radiation therapy =\< 4 weeks of registration (TURBT is allowed).

• Not pregnant and not nursing. This study involves an agent that has known genotoxic, mutagenic and teratogenic effects. For women of childbearing potential only, a negative pregnancy test done =\< 14 days prior to registration is required

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1

• Absolute neutrophil count (ANC) \>= 1,000/mm\^3

• Platelet count \>= 100,000/mm\^3

• Calculated creatinine clearance ≥ 55 mL/min using formula per institutional standard or investigator's discretion. The same formula should be used to calculate all subsequent creatinine clearances.

• Total bilirubin =\< 1.5 x upper limit of normal (ULN)

• \* (For patients with documented Gilbert's syndrome Total Bilirubin =\< 3 x ULN)

• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x ULN

• Alkaline phosphatase =\< 2.5 x ULN

• No evidence of New York Heart Association (NYHA) functional class III or IV heart disease

• No ongoing cardiac dysrhythmias of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade \>= 2

• No pre-existing sensory grade \>= 2 neuropathy

• No pre-existing grade \>= 2 hearing loss

• No serious intercurrent medical or psychiatric illness, including serious active infection

• None of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack

• No known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection. HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with the drugs used in this trial. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy, when indicated

• No history of allergic reaction attributed to compounds of similar chemical or biologic composition to the agents used in this study

• No concurrent treatment on another clinical trial; supportive care trials or non-therapeutic trials (e.g., quality of life) are allowed

• No prior malignancy except for: adequately treated basal or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years. Patients with localized prostate cancer who are being followed by an active surveillance program are also eligible

• Step 2 Patient Registration Eligibility Criteria

• Patients must have completed 4 or more cycles of protocol-directed chemotherapy and DDR gene results must be available

• Step 3 Patient Registration Eligibility Criteria (only patients with a DDR gene alteration)

• Deleterious alteration within 1 or more of 9 pre-defined DDR genes within the pre-treatment TURBT deoxyribonucleic acid (DNA)

• Cystoscopy and imaging performed to determine stage/treatment assignment

Locations
United States
Alaska
Fairbanks Memorial Hospital
RECRUITING
Fairbanks
Arkansas
Mercy Hospital Fort Smith
RECRUITING
Fort Smith
CHI Saint Vincent Cancer Center Hot Springs
SUSPENDED
Hot Springs
University of Arkansas for Medical Sciences
RECRUITING
Little Rock
Arizona
CTCA at Western Regional Medical Center
ACTIVE_NOT_RECRUITING
Goodyear
Cancer Center at Saint Joseph's
RECRUITING
Phoenix
California
Mission Hope Medical Oncology - Arroyo Grande
RECRUITING
Arroyo Grande
Mercy Cancer Center - Carmichael
RECRUITING
Carmichael
Mercy San Juan Medical Center
RECRUITING
Carmichael
Mercy Cancer Center - Elk Grove
RECRUITING
Elk Grove
Cedars Sinai Medical Center
ACTIVE_NOT_RECRUITING
Los Angeles
Contra Costa Regional Medical Center
RECRUITING
Martinez
Fremont - Rideout Cancer Center
RECRUITING
Marysville
Mercy Cancer Center
SUSPENDED
Merced
Mercy Cancer Center - Rocklin
RECRUITING
Rocklin
Mercy Cancer Center - Sacramento
RECRUITING
Sacramento
University of California Davis Comprehensive Cancer Center
RECRUITING
Sacramento
Pacific Central Coast Health Center-San Luis Obispo
RECRUITING
San Luis Obispo
Mission Hope Medical Oncology - Santa Maria
RECRUITING
Santa Maria
Saint Joseph's Medical Center
RECRUITING
Stockton
BASS Medical Group - Lennon
RECRUITING
Walnut Creek
Woodland Memorial Hospital
RECRUITING
Woodland
Colorado
Rocky Mountain Cancer Centers-Aurora
RECRUITING
Aurora
The Medical Center of Aurora
SUSPENDED
Aurora
Rocky Mountain Cancer Centers-Boulder
RECRUITING
Boulder
Penrose-Saint Francis Healthcare
RECRUITING
Colorado Springs
Rocky Mountain Cancer Centers-Penrose
RECRUITING
Colorado Springs
Saint Francis Cancer Center
RECRUITING
Colorado Springs
AdventHealth Porter
SUSPENDED
Denver
Presbyterian - Saint Lukes Medical Center - Health One
RECRUITING
Denver
CommonSpirit Cancer Center Mercy
SUSPENDED
Durango
Mercy Medical Center
SUSPENDED
Durango
Mountain Blue Cancer Care Center - Swedish
SUSPENDED
Englewood
Swedish Medical Center
SUSPENDED
Englewood
The Melanoma and Skin Cancer Institute
RECRUITING
Englewood
Mountain Blue Cancer Care Center
SUSPENDED
Golden
Banner North Colorado Medical Center
SUSPENDED
Greeley
Rocky Mountain Cancer Centers-Lakewood
SUSPENDED
Lakewood
Saint Anthony Hospital
RECRUITING
Lakewood
AdventHealth Littleton
SUSPENDED
Littleton
Rocky Mountain Cancer Centers-Littleton
RECRUITING
Littleton
Sky Ridge Medical Center
SUSPENDED
Lone Tree
Longmont United Hospital
RECRUITING
Longmont
Rocky Mountain Cancer Centers-Longmont
SUSPENDED
Longmont
Banner McKee Medical Center
SUSPENDED
Loveland
AdventHealth Parker
SUSPENDED
Parker
Rocky Mountain Cancer Centers-Parker
SUSPENDED
Parker
Rocky Mountain Cancer Centers - Pueblo
SUSPENDED
Pueblo
Saint Mary Corwin Medical Center
RECRUITING
Pueblo
Rocky Mountain Cancer Centers-Thornton
RECRUITING
Thornton
Saint Anthony North Hospital
RECRUITING
Westminster
Connecticut
Hartford Hospital
RECRUITING
Hartford
Midstate Medical Center
RECRUITING
Meriden
The Hospital of Central Connecticut
RECRUITING
New Britain
William Backus Hospital
RECRUITING
Norwich
Florida
Holy Cross Hospital
RECRUITING
Fort Lauderdale
University of Florida Health Science Center - Gainesville
RECRUITING
Gainesville
Iowa
Saint Anthony Regional Hospital
ACTIVE_NOT_RECRUITING
Carroll
Mercy Cancer Center-West Lakes
SUSPENDED
Clive
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
SUSPENDED
Clive
Alegent Health Mercy Hospital
SUSPENDED
Council Bluffs
Greater Regional Medical Center
SUSPENDED
Creston
Broadlawns Medical Center
ACTIVE_NOT_RECRUITING
Des Moines
Iowa Lutheran Hospital
ACTIVE_NOT_RECRUITING
Des Moines
Iowa Methodist Medical Center
ACTIVE_NOT_RECRUITING
Des Moines
Mercy Medical Center - Des Moines
SUSPENDED
Des Moines
UI Health Care Mission Cancer and Blood - Des Moines Clinic
ACTIVE_NOT_RECRUITING
Des Moines
UI Health Care Mission Cancer and Blood - Laurel Clinic
SUSPENDED
Des Moines
UI Healthcare Mission Cancer and Blood - Fort Dodge
ACTIVE_NOT_RECRUITING
Fort Dodge
Mercy Medical Center-West Lakes
SUSPENDED
West Des Moines
Methodist West Hospital
ACTIVE_NOT_RECRUITING
West Des Moines
Idaho
Saint Alphonsus Cancer Care Center-Boise
RECRUITING
Boise
Saint Alphonsus Cancer Care Center-Caldwell
RECRUITING
Caldwell
Kootenai Health - Coeur d'Alene
RECRUITING
Coeur D'alene
Walter Knox Memorial Hospital
SUSPENDED
Emmett
Idaho Urologic Institute-Meridian
RECRUITING
Meridian
Saint Alphonsus Cancer Care Center-Nampa
RECRUITING
Nampa
Kootenai Clinic Cancer Services - Post Falls
RECRUITING
Post Falls
Kootenai Clinic Cancer Services - Sandpoint
SUSPENDED
Sandpoint
Illinois
OSF Saint Anthony's Health Center
RECRUITING
Alton
Rush-Copley Medical Center
RECRUITING
Aurora
Illinois CancerCare-Bloomington
RECRUITING
Bloomington
Illinois CancerCare-Canton
RECRUITING
Canton
Memorial Hospital of Carbondale
RECRUITING
Carbondale
SIH Cancer Institute
RECRUITING
Carterville
Illinois CancerCare-Carthage
RECRUITING
Carthage
Centralia Oncology Clinic
RECRUITING
Centralia
Saint Mary's Hospital
SUSPENDED
Centralia
University of Illinois
ACTIVE_NOT_RECRUITING
Chicago
Carle at The Riverfront
RECRUITING
Danville
Cancer Care Specialists of Illinois - Decatur
RECRUITING
Decatur
Decatur Memorial Hospital
RECRUITING
Decatur
Illinois CancerCare-Dixon
RECRUITING
Dixon
Carle Physician Group-Effingham
RECRUITING
Effingham
Crossroads Cancer Center
RECRUITING
Effingham
Illinois CancerCare-Eureka
RECRUITING
Eureka
Illinois CancerCare-Galesburg
RECRUITING
Galesburg
Western Illinois Cancer Treatment Center
SUSPENDED
Galesburg
Ingalls Memorial Hospital
RECRUITING
Harvey
Illinois CancerCare-Kewanee Clinic
RECRUITING
Kewanee
Illinois CancerCare-Macomb
RECRUITING
Macomb
Carle Physician Group-Mattoon/Charleston
RECRUITING
Mattoon
SSM Health Good Samaritan
RECRUITING
Mount Vernon
Cancer Care Center of O'Fallon
RECRUITING
O'fallon
HSHS Saint Elizabeth's Hospital
RECRUITING
O'fallon
Illinois CancerCare-Ottawa Clinic
RECRUITING
Ottawa
Illinois CancerCare-Pekin
RECRUITING
Pekin
OSF Saint Francis Radiation Oncology at Pekin
RECRUITING
Pekin
Illinois CancerCare-Peoria
RECRUITING
Peoria
Methodist Medical Center of Illinois
RECRUITING
Peoria
OSF Saint Francis Medical Center
RECRUITING
Peoria
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
RECRUITING
Peoria
Illinois CancerCare-Peru
RECRUITING
Peru
Valley Radiation Oncology
RECRUITING
Peru
Illinois CancerCare-Princeton
RECRUITING
Princeton
UW Health Carbone Cancer Center Rockford
RECRUITING
Rockford
Southern Illinois University School of Medicine
RECRUITING
Springfield
Springfield Clinic
RECRUITING
Springfield
Springfield Memorial Hospital
RECRUITING
Springfield
Southwest Illinois Health Services LLP
SUSPENDED
Swansea
Carle Cancer Center
RECRUITING
Urbana
The Carle Foundation Hospital
RECRUITING
Urbana
Illinois CancerCare - Washington
RECRUITING
Washington
Indiana
Reid Health
RECRUITING
Richmond
Kansas
Central Care Cancer Center - Garden City
RECRUITING
Garden City
Central Care Cancer Center - Great Bend
RECRUITING
Great Bend
University of Kansas Cancer Center
ACTIVE_NOT_RECRUITING
Kansas City
Mercy Hospital Pittsburg
RECRUITING
Pittsburg
University of Kansas Hospital-Westwood Cancer Center
ACTIVE_NOT_RECRUITING
Westwood
Kentucky
Flaget Memorial Hospital
SUSPENDED
Bardstown
Commonwealth Cancer Center-Corbin
SUSPENDED
Corbin
Saint Joseph Hospital
RECRUITING
Lexington
Saint Joseph Hospital East
RECRUITING
Lexington
Saint Joseph Radiation Oncology Resource Center
RECRUITING
Lexington
Saint Joseph London
SUSPENDED
London
Jewish Hospital
SUSPENDED
Louisville
Saints Mary and Elizabeth Hospital
SUSPENDED
Louisville
UofL Health Medical Center Northeast
SUSPENDED
Louisville
Jewish Hospital Medical Center South
SUSPENDED
Shepherdsville
Louisiana
Louisiana Hematology Oncology Associates LLC
RECRUITING
Baton Rouge
LSU Health Baton Rouge-North Clinic
RECRUITING
Baton Rouge
Mary Bird Perkins Cancer Center
RECRUITING
Baton Rouge
Our Lady of The Lake
RECRUITING
Baton Rouge
Our Lady of the Lake Physician Group
RECRUITING
Baton Rouge
Northshore Oncology Associates-Covington
RECRUITING
Covington
Terrebonne General Medical Center
RECRUITING
Houma
East Jefferson General Hospital
RECRUITING
Metairie
LSU Healthcare Network / Metairie Multi-Specialty Clinic
RECRUITING
Metairie
Mary Bird Perkins Cancer Center - Metairie
RECRUITING
Metairie
Louisiana State University Health Science Center
RECRUITING
New Orleans
Ochsner Medical Center Jefferson
ACTIVE_NOT_RECRUITING
New Orleans
University Medical Center New Orleans
ACTIVE_NOT_RECRUITING
New Orleans
Massachusetts
Mercy Medical Center
SUSPENDED
Springfield
Maryland
Maryland Proton Treatment Center
ACTIVE_NOT_RECRUITING
Baltimore
University of Maryland/Greenebaum Cancer Center
ACTIVE_NOT_RECRUITING
Baltimore
Central Maryland Radiation Oncology in Howard County
ACTIVE_NOT_RECRUITING
Columbia
UM Baltimore Washington Medical Center/Tate Cancer Center
ACTIVE_NOT_RECRUITING
Glen Burnie
Michigan
MyMichigan Medical Center Gratiot
RECRUITING
Alma
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
RECRUITING
Ann Arbor
Trinity Health IHA Medical Group Hematology Oncology - Brighton
RECRUITING
Brighton
Trinity Health Medical Center - Brighton
RECRUITING
Brighton
Trinity Health IHA Medical Group Hematology Oncology - Canton
RECRUITING
Canton
Trinity Health Medical Center - Canton
RECRUITING
Canton
Caro Cancer Center
SUSPENDED
Caro
Chelsea Hospital
RECRUITING
Chelsea
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
RECRUITING
Chelsea
Hematology Oncology Consultants-Clarkston
SUSPENDED
Clarkston
Newland Medical Associates-Clarkston
SUSPENDED
Clarkston
Henry Ford Health Saint John Hospital
RECRUITING
Detroit
Henry Ford River District Hospital
SUSPENDED
East China Township
Cancer Hematology Centers - Flint
SUSPENDED
Flint
Genesee Hematology Oncology PC
SUSPENDED
Flint
Genesys Hurley Cancer Institute
RECRUITING
Flint
Hurley Medical Center
RECRUITING
Flint
Henry Ford Saint John Hospital - Academic
SUSPENDED
Grosse Pointe Woods
Henry Ford Saint John Hospital - Breast
SUSPENDED
Grosse Pointe Woods
Henry Ford Saint John Hospital - Van Elslander
RECRUITING
Grosse Pointe Woods
University of Michigan Health - Sparrow Lansing
RECRUITING
Lansing
Hope Cancer Clinic
SUSPENDED
Livonia
Trinity Health Saint Mary Mercy Livonia Hospital
RECRUITING
Livonia
Henry Ford Saint John Hospital - Macomb Medical
RECRUITING
Macomb
Henry Ford Warren Hospital - Breast Macomb
SUSPENDED
Macomb
Saint Mary's Oncology/Hematology Associates of Marlette
SUSPENDED
Marlette
MyMichigan Medical Center Midland
RECRUITING
Midland
Hope Cancer Center
SUSPENDED
Pontiac
Michigan Healthcare Professionals Pontiac
RECRUITING
Pontiac
Newland Medical Associates-Pontiac
SUSPENDED
Pontiac
Trinity Health Saint Joseph Mercy Oakland Hospital
RECRUITING
Pontiac
Henry Ford Rochester Hospital
SUSPENDED
Rochester Hills
MyMichigan Medical Center Saginaw
RECRUITING
Saginaw
Oncology Hematology Associates of Saginaw Valley PC
SUSPENDED
Saginaw
Bhadresh Nayak MD PC-Sterling Heights
SUSPENDED
Sterling Heights
MyMichigan Medical Center Tawas
RECRUITING
Tawas City
Advanced Breast Care Center PLLC
SUSPENDED
Warren
Henry Ford Health Warren Hospital
RECRUITING
Warren
Henry Ford Madison Heights Hospital - Breast
SUSPENDED
Warren
Henry Ford Warren Hospital - GLCMS
SUSPENDED
Warren
Macomb Hematology Oncology PC
SUSPENDED
Warren
Saint Mary's Oncology/Hematology Associates of West Branch
SUSPENDED
West Branch
Huron Gastroenterology PC
SUSPENDED
Ypsilanti
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
RECRUITING
Ypsilanti
Minnesota
Sanford Joe Lueken Cancer Center
RECRUITING
Bemidji
Essentia Health Saint Joseph's Medical Center
RECRUITING
Brainerd
Fairview Ridges Hospital
SUSPENDED
Burnsville
Minnesota Oncology - Burnsville
RECRUITING
Burnsville
Mercy Hospital
RECRUITING
Coon Rapids
Essentia Health - Deer River Clinic
RECRUITING
Deer River
Essentia Health Saint Mary's - Detroit Lakes Clinic
RECRUITING
Detroit Lakes
Essentia Health Cancer Center
RECRUITING
Duluth
Essentia Health Saint Mary's Medical Center
RECRUITING
Duluth
Miller-Dwan Hospital
RECRUITING
Duluth
Fairview Southdale Hospital
RECRUITING
Edina
Lake Region Healthcare Corporation-Cancer Care
SUSPENDED
Fergus Falls
Essentia Health - Fosston
RECRUITING
Fosston
Unity Hospital
ACTIVE_NOT_RECRUITING
Fridley
Essentia Health Hibbing Clinic
RECRUITING
Hibbing
Fairview Clinics and Surgery Center Maple Grove
RECRUITING
Maple Grove
Minnesota Oncology Hematology PA-Maplewood
RECRUITING
Maplewood
Saint John's Hospital - Healtheast
RECRUITING
Maplewood
Abbott-Northwestern Hospital
RECRUITING
Minneapolis
Health Partners Inc
RECRUITING
Minneapolis
Hennepin County Medical Center
RECRUITING
Minneapolis
Monticello Cancer Center
RECRUITING
Monticello
New Ulm Medical Center
SUSPENDED
New Ulm
Essentia Health - Park Rapids
RECRUITING
Park Rapids
North Memorial Medical Health Center
RECRUITING
Robbinsdale
Coborn Cancer Center at Saint Cloud Hospital
RECRUITING
Saint Cloud
Park Nicollet Clinic - Saint Louis Park
RECRUITING
Saint Louis Park
Regions Hospital
RECRUITING
Saint Paul
United Hospital
RECRUITING
Saint Paul
Essentia Health Sandstone
RECRUITING
Sandstone
Saint Francis Regional Medical Center
RECRUITING
Shakopee
Lakeview Hospital
RECRUITING
Stillwater
Sanford Thief River Falls Medical Center
SUSPENDED
Thief River Falls
Essentia Health Virginia Clinic
RECRUITING
Virginia
Ridgeview Medical Center
RECRUITING
Waconia
Rice Memorial Hospital
RECRUITING
Willmar
Minnesota Oncology Hematology PA-Woodbury
RECRUITING
Woodbury
Sanford Cancer Center Worthington
SUSPENDED
Worthington
Fairview Lakes Medical Center
SUSPENDED
Wyoming
Missouri
Mercy Oncology and Hematology - Clayton-Clarkson
SUSPENDED
Ballwin
Central Care Cancer Center - Bolivar
RECRUITING
Bolivar
Parkland Health Center-Bonne Terre
SUSPENDED
Bonne Terre
Mercy Cancer Center - Cape Girardeau
RECRUITING
Cape Girardeau
Saint Francis Medical Center
RECRUITING
Cape Girardeau
MU Health - University Hospital/Ellis Fischel Cancer Center
RECRUITING
Columbia
Siteman Cancer Center at West County Hospital
RECRUITING
Creve Coeur
Parkland Health Center - Farmington
RECRUITING
Farmington
MU Health Care Goldschmidt Cancer Center
ACTIVE_NOT_RECRUITING
Jefferson City
Freeman Health System
RECRUITING
Joplin
Mercy Hospital Joplin
RECRUITING
Joplin
Lake Regional Hospital
RECRUITING
Osage Beach
Mercy Clinic-Rolla-Cancer and Hematology
RECRUITING
Rolla
Phelps Health Delbert Day Cancer Institute
RECRUITING
Rolla
Heartland Regional Medical Center
RECRUITING
Saint Joseph
Sainte Genevieve County Memorial Hospital
RECRUITING
Sainte Genevieve
CoxHealth South Hospital
RECRUITING
Springfield
Mercy Hospital Springfield
RECRUITING
Springfield
Mercy Hospital Saint Louis
RECRUITING
St Louis
Mercy Hospital South
RECRUITING
St Louis
Missouri Baptist Medical Center
RECRUITING
St Louis
Siteman Cancer Center at Christian Hospital
RECRUITING
St Louis
Siteman Cancer Center-South County
RECRUITING
St Louis
Washington University School of Medicine
RECRUITING
St Louis
Missouri Baptist Sullivan Hospital
RECRUITING
Sullivan
BJC Outpatient Center at Sunset Hills
RECRUITING
Sunset Hills
Montana
Community Hospital of Anaconda
SUSPENDED
Anaconda
Billings Clinic Cancer Center
RECRUITING
Billings
Bozeman Health Deaconess Hospital
RECRUITING
Bozeman
Benefis Sletten Cancer Institute
RECRUITING
Great Falls
Great Falls Clinic
RECRUITING
Great Falls
Hi-Line Sletten Cancer Center
RECRUITING
Havre
Saint Peter's Community Hospital
SUSPENDED
Helena
Logan Health Medical Center
RECRUITING
Kalispell
Community Medical Center
RECRUITING
Missoula
North Carolina
Southeastern Medical Oncology Center-Clinton
ACTIVE_NOT_RECRUITING
Clinton
Southeastern Medical Oncology Center-Goldsboro
ACTIVE_NOT_RECRUITING
Goldsboro
Wayne Memorial Hospital
ACTIVE_NOT_RECRUITING
Goldsboro
Onslow Memorial Hospital
ACTIVE_NOT_RECRUITING
Jacksonville
Southeastern Medical Oncology Center-Jacksonville
ACTIVE_NOT_RECRUITING
Jacksonville
North Dakota
Sanford Bismarck Medical Center
RECRUITING
Bismarck
Essentia Health Cancer Center-South University Clinic
RECRUITING
Fargo
Sanford Broadway Medical Center
RECRUITING
Fargo
Sanford Medical Center Fargo
SUSPENDED
Fargo
Sanford Roger Maris Cancer Center
RECRUITING
Fargo
Sanford South University Medical Center
SUSPENDED
Fargo
Essentia Health - Jamestown Clinic
RECRUITING
Jamestown
Nebraska
Nebraska Cancer Specialists/Oncology Hematology West PC
SUSPENDED
Grand Island
CHI Health Good Samaritan
RECRUITING
Kearney
Fred and Pamela Buffett Cancer Center - Kearney
SUSPENDED
Kearney
Saint Elizabeth Regional Medical Center
SUSPENDED
Lincoln
Alegent Health Bergan Mercy Medical Center
RECRUITING
Omaha
Alegent Health Immanuel Medical Center
SUSPENDED
Omaha
Alegent Health Lakeside Hospital
RECRUITING
Omaha
Creighton University Medical Center
RECRUITING
Omaha
Hematology and Oncology Consultants PC
SUSPENDED
Omaha
Midlands Community Hospital
SUSPENDED
Papillion
New Jersey
Memorial Sloan Kettering Basking Ridge
RECRUITING
Basking Ridge
Englewood Hospital and Medical Center
RECRUITING
Englewood
Memorial Sloan Kettering Monmouth
RECRUITING
Middletown
Memorial Sloan Kettering Bergen
RECRUITING
Montvale
New York
Roswell Park Cancer Institute
ACTIVE_NOT_RECRUITING
Buffalo
Memorial Sloan Kettering Commack
RECRUITING
Commack
Memorial Sloan Kettering Westchester
RECRUITING
Harrison
Laura and Isaac Perlmutter Cancer Center at NYU Langone
RECRUITING
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
NYP/Weill Cornell Medical Center
RECRUITING
New York
Upstate Cancer Center at Oswego
RECRUITING
Oswego
Upstate Cancer Center Radiation Oncology at Oswego
RECRUITING
Oswego
University of Rochester
RECRUITING
Rochester
State University of New York Upstate Medical University
RECRUITING
Syracuse
Memorial Sloan Kettering Nassau
RECRUITING
Uniondale
Upstate Cancer Center at Verona
RECRUITING
Verona
Ohio
Indu and Raj Soin Medical Center
RECRUITING
Beavercreek
Saint Elizabeth Boardman Hospital
RECRUITING
Boardman
Dayton Physicians LLC-Miami Valley South
RECRUITING
Centerville
Miami Valley Hospital South
RECRUITING
Centerville
Bethesda North Hospital
RECRUITING
Cincinnati
Good Samaritan Hospital - Cincinnati
RECRUITING
Cincinnati
Oncology Hematology Care Inc-Kenwood
SUSPENDED
Cincinnati
TriHealth Cancer Institute-Anderson
SUSPENDED
Cincinnati
TriHealth Cancer Institute-Westside
SUSPENDED
Cincinnati
Cleveland Clinic Foundation
RECRUITING
Cleveland
Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
Dayton Physician LLC - Englewood
RECRUITING
Dayton
Good Samaritan Hospital - Dayton
SUSPENDED
Dayton
Miami Valley Hospital
RECRUITING
Dayton
Miami Valley Hospital North
RECRUITING
Dayton
Premier Blood and Cancer Center
RECRUITING
Dayton
Armes Family Cancer Center
RECRUITING
Findlay
Blanchard Valley Hospital
RECRUITING
Findlay
Orion Cancer Care
RECRUITING
Findlay
Atrium Medical Center-Middletown Regional Hospital
RECRUITING
Franklin
Dayton Physicians LLC-Atrium
RECRUITING
Franklin
Dayton Physicians LLC-Wayne
RECRUITING
Greenville
Miami Valley Cancer Care and Infusion
RECRUITING
Greenville
Wayne Hospital
RECRUITING
Greenville
First Dayton Cancer Care
SUSPENDED
Kettering
Greater Dayton Cancer Center
RECRUITING
Kettering
Kettering Medical Center
RECRUITING
Kettering
Springfield Regional Cancer Center
SUSPENDED
Springfield
Springfield Regional Medical Center
SUSPENDED
Springfield
Dayton Physicians LLC - Troy
RECRUITING
Troy
Upper Valley Medical Center
RECRUITING
Troy
Saint Joseph Warren Hospital
RECRUITING
Warren
Saint Elizabeth Youngstown Hospital
RECRUITING
Youngstown
Oklahoma
Mercy Hospital Oklahoma City
RECRUITING
Oklahoma City
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Oklahoma Cancer Specialists and Research Institute-Tulsa
ACTIVE_NOT_RECRUITING
Tulsa
Oregon
Saint Alphonsus Cancer Care Center-Baker City
SUSPENDED
Baker City
Saint Alphonsus Cancer Care Center-Ontario
SUSPENDED
Ontario
Pennsylvania
Lehigh Valley Hospital-Cedar Crest
RECRUITING
Allentown
Lehigh Valley Hospital - Muhlenberg
RECRUITING
Bethlehem
Geisinger Medical Center
RECRUITING
Danville
Pocono Medical Center
RECRUITING
East Stroudsburg
Geisinger Medical Center-Cancer Center Hazleton
RECRUITING
Hazleton
Lehigh Valley Hospital-Hazleton
SUSPENDED
Hazleton
Geisinger Medical Oncology-Lewisburg
RECRUITING
Lewisburg
Lewistown Hospital
RECRUITING
Lewistown
Geisinger Cancer Services-Pottsville
RECRUITING
Pottsville
Community Medical Center
RECRUITING
Scranton
Geisinger Medical Oncology-Selinsgrove
RECRUITING
Selinsgrove
Geisinger Wyoming Valley/Henry Cancer Center
RECRUITING
Wilkes-barre
Rhode Island
Rhode Island Hospital
RECRUITING
Providence
South Carolina
Prisma Health Cancer Institute - Spartanburg
ACTIVE_NOT_RECRUITING
Boiling Springs
Medical University of South Carolina
ACTIVE_NOT_RECRUITING
Charleston
Prisma Health Cancer Institute - Laurens
ACTIVE_NOT_RECRUITING
Clinton
Prisma Health Cancer Institute - Easley
ACTIVE_NOT_RECRUITING
Easley
Gibbs Cancer Center-Gaffney
RECRUITING
Gaffney
Prisma Health Cancer Institute - Butternut
ACTIVE_NOT_RECRUITING
Greenville
Prisma Health Cancer Institute - Eastside
ACTIVE_NOT_RECRUITING
Greenville
Prisma Health Cancer Institute - Faris
ACTIVE_NOT_RECRUITING
Greenville
Prisma Health Greenville Memorial Hospital
ACTIVE_NOT_RECRUITING
Greenville
Gibbs Cancer Center-Pelham
RECRUITING
Greer
Prisma Health Cancer Institute - Greer
ACTIVE_NOT_RECRUITING
Greer
Prisma Health Cancer Institute - Seneca
ACTIVE_NOT_RECRUITING
Seneca
Spartanburg Medical Center
RECRUITING
Spartanburg
SMC Center for Hematology Oncology Union
RECRUITING
Union
South Dakota
Sanford Cancer Center Oncology Clinic
RECRUITING
Sioux Falls
Sanford USD Medical Center - Sioux Falls
RECRUITING
Sioux Falls
Tennessee
Memorial Hospital
SUSPENDED
Chattanooga
Pulmonary Medicine Center of Chattanooga-Hixson
SUSPENDED
Hixson
Memorial GYN Plus
SUSPENDED
Ooltewah
Texas
Saint Joseph Regional Cancer Center
SUSPENDED
Bryan
Parkland Memorial Hospital
RECRUITING
Dallas
UT Southwestern Simmons Cancer Center - RedBird
RECRUITING
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
RECRUITING
Dallas
UT Southwestern/Simmons Cancer Center-Fort Worth
RECRUITING
Fort Worth
UT Southwestern Clinical Center at Richardson/Plano
RECRUITING
Richardson
Washington
Highline Medical Center-Main Campus
SUSPENDED
Burien
Saint Elizabeth Hospital
SUSPENDED
Enumclaw
Saint Francis Hospital
SUSPENDED
Federal Way
Saint Clare Hospital
SUSPENDED
Lakewood
Harrison HealthPartners Hematology and Oncology-Poulsbo
ACTIVE_NOT_RECRUITING
Poulsbo
Saint Michael Cancer Center
RECRUITING
Silverdale
Franciscan Research Center-Northwest Medical Plaza
SUSPENDED
Tacoma
Northwest Medical Specialties PLLC
SUSPENDED
Tacoma
Wisconsin
Langlade Hospital and Cancer Center
RECRUITING
Antigo
Duluth Clinic Ashland
RECRUITING
Ashland
Northwest Wisconsin Cancer Center
RECRUITING
Ashland
Marshfield Medical Center-EC Cancer Center
RECRUITING
Eau Claire
Essentia Health-Hayward Clinic
RECRUITING
Hayward
Gundersen Lutheran Medical Center
RECRUITING
La Crosse
Marshfield Medical Center - Ladysmith
RECRUITING
Ladysmith
Marshfield Medical Center-Marshfield
RECRUITING
Marshfield
Aspirus Medford Hospital
RECRUITING
Medford
Marshfield Medical Center - Minocqua
RECRUITING
Minocqua
Cancer Center of Western Wisconsin
RECRUITING
New Richmond
Aspirus Cancer Care - James Beck Cancer Center
RECRUITING
Rhinelander
Marshfield Medical Center-Rice Lake
RECRUITING
Rice Lake
Essentia Health-Spooner Clinic
RECRUITING
Spooner
Aspirus Cancer Care - Stevens Point
RECRUITING
Stevens Point
Marshfield Medical Center-River Region at Stevens Point
RECRUITING
Stevens Point
Essentia Health Saint Mary's Hospital - Superior
RECRUITING
Superior
Aspirus Regional Cancer Center
RECRUITING
Wausau
Marshfield Medical Center - Weston
RECRUITING
Weston
Aspirus Cancer Care - Wisconsin Rapids
RECRUITING
Wisconsin Rapids
West Virginia
United Hospital Center
ACTIVE_NOT_RECRUITING
Bridgeport
WVUH-Berkely Medical Center
ACTIVE_NOT_RECRUITING
Martinsburg
West Virginia University Healthcare
ACTIVE_NOT_RECRUITING
Morgantown
Camden Clark Medical Center
ACTIVE_NOT_RECRUITING
Parkersburg
Wyoming
Billings Clinic-Cody
SUSPENDED
Cody
Welch Cancer Center
SUSPENDED
Sheridan
Contact Information
Primary
Gopa Iyer, MD
iyerg@mskcc.org
646-888-4737
Time Frame
Start Date: 2018-12-10
Estimated Completion Date: 2029-02-01
Participants
Target number of participants: 271
Treatments
Experimental: Arm I (gemcitabine, cisplatin, bladder sparing)
Participants receive gemcitabine hydrochloride IV over 30 minutes on day 1, cisplatin IV on days 1 and 2, and pegfilgrastim SC on day 3. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unaccepted toxicity. Participants with DDR gene alteration and disease stage \< cT1 undergo bladder sparing.
Experimental: Arm II (gemcitabine, cisplatin, cystectomy, chemoradiotherapy)
Participants receive gemcitabine hydrochloride IV over 30 minutes on day 1, cisplatin IV on days 1 and 2, and pegfilgrastim SC on day 3. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unaccepted toxicity. Participants with DDR gene alteration and disease stage \>= cT1 or participants without DDR gene alteration undergo radical cystectomy or chemoradiotherapy.
Related Therapeutic Areas
Sponsors
Leads: Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

Similar Clinical Trials