Gemcitabine Hydrochloride and Cisplatin With or Without Nab-Paclitaxel in Treating Patients With Newly Diagnosed Advanced Biliary Tract Cancers

February 23, 2024 updated by: SWOG Cancer Research Network

A Phase III Randomized Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel Versus Gemcitabine and Cisplatin in Newly Diagnosed, Advanced Biliary Tract Cancers

This phase III trial studies how well gemcitabine hydrochloride and cisplatin given with or without nab-paclitaxel work in treating patients with newly diagnosed biliary tract cancers that have spread to other places in the body. Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, and nab-paclitaxel, 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. It is not known if giving gemcitabine hydrochloride and cisplatin with or without nab-paclitaxel may work better at treating biliary tract cancers.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To compare overall survival (OS) in patients with untreated, advanced biliary cancers treated with gemcitabine hydrochloride (gemcitabine) and cisplatin (GC) versus those treated with gemcitabine, cisplatin, and nab-Paclitaxel (GCN).

SECONDARY OBJECTIVES:

I. To compare progression-free survival (PFS) in patients treated with GC versus GCN.

II. To compare overall response rate (ORR), complete and partial, confirmed and unconfirmed, in the subset of patients with measurable disease treated with GC versus GCN.

III. To compare disease control rate (confirmed and unconfirmed; complete response + partial response + stable disease) (DCR) in patients treated with GC versus GCN.

IV. To evaluate the frequency and severity of toxicity associated with GC and GCN in the patient population.

V. To explore the correlation between change in cancer antigen 19-9 (CA19-9) levels from baseline to post-treatment (after 3 cycles) and overall response rate, in each treatment arm separately and in the total cohort.

ADDITIONAL OBJECTIVES:

I. To bank tissue and blood for future translational medicine studies.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive nab-paclitaxel intravenously (IV) over 30 minutes, cisplatin IV over 60 minutes, and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive cisplatin IV over 60 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 2 years and then at the end of year 3.

Study Type

Interventional

Enrollment (Actual)

452

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alaska
  - Anchorage, Alaska, United States, 98508
    - Anchorage Associates in Radiation Medicine
  - Anchorage, Alaska, United States, 99508
    - Alaska Breast Care and Surgery LLC
  - Anchorage, Alaska, United States, 99508
    - Alaska Oncology and Hematology LLC
  - Anchorage, Alaska, United States, 99508
    - Alaska Women's Cancer Care
  - Anchorage, Alaska, United States, 99508
    - Anchorage Oncology Centre
  - Anchorage, Alaska, United States, 99508
    - Katmai Oncology Group
  - Anchorage, Alaska, United States, 99508
    - Providence Alaska Medical Center
  - Anchorage, Alaska, United States, 99504
    - Anchorage Radiation Therapy Center
- Arizona
  - Goodyear, Arizona, United States, 85338
    - CTCA at Western Regional Medical Center
  - Kingman, Arizona, United States, 86401
    - Kingman Regional Medical Center
  - Phoenix, Arizona, United States, 85054
    - Mayo Clinic Hospital in Arizona
  - Phoenix, Arizona, United States, 85004
    - Cancer Center at Saint Joseph's
  - Scottsdale, Arizona, United States, 85259
    - Mayo Clinic in Arizona
  - Tucson, Arizona, United States, 85704
    - University of Arizona Cancer Center-Orange Grove Campus
  - Tucson, Arizona, United States, 85719
    - Banner University Medical Center - Tucson
  - Tucson, Arizona, United States, 85719
    - University of Arizona Cancer Center-North Campus
- Arkansas
  - Fort Smith, Arkansas, United States, 72903
    - Mercy Hospital Fort Smith
  - Hot Springs, Arkansas, United States, 71913
    - CHI Saint Vincent Cancer Center Hot Springs
  - Jonesboro, Arkansas, United States, 72401
    - Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
  - Little Rock, Arkansas, United States, 72205
    - University of Arkansas for Medical Sciences
- California
  - Arroyo Grande, California, United States, 93420
    - PCR Oncology
  - Arroyo Grande, California, United States, 93420
    - Mission Hope Medical Oncology - Arroyo Grande
  - Burbank, California, United States, 91505
    - Providence Saint Joseph Medical Center/Disney Family Cancer Center
  - Clovis, California, United States, 93611
    - Community Cancer Institute
  - Clovis, California, United States, 93611
    - University Oncology Associates
  - Corona, California, United States, 92879
    - City of Hope Corona
  - Duarte, California, United States, 91010
    - City of Hope Comprehensive Cancer Center
  - Los Angeles, California, United States, 90033
    - USC / Norris Comprehensive Cancer Center
  - Los Angeles, California, United States, 90033
    - Los Angeles County-USC Medical Center
  - Marysville, California, United States, 95901
    - Fremont - Rideout Cancer Center
  - Mission Hills, California, United States, 91345
    - City of Hope Mission Hills
  - Newport Beach, California, United States, 92663
    - USC Norris Oncology/Hematology-Newport Beach
  - Orange, California, United States, 92868
    - UC Irvine Health/Chao Family Comprehensive Cancer Center
  - Palo Alto, California, United States, 94304
    - Stanford Cancer Institute Palo Alto
  - Sacramento, California, United States, 95817
    - University of California Davis Comprehensive Cancer Center
  - Salinas, California, United States, 93901
    - Salinas Valley Memorial
  - San Francisco, California, United States, 94158
    - UCSF Medical Center-Mission Bay
  - San Luis Obispo, California, United States, 93401
    - Pacific Central Coast Health Center-San Luis Obispo
  - Santa Clarita, California, United States, 91355
    - City of Hope - Santa Clarita
  - Santa Maria, California, United States, 93444
    - Mission Hope Medical Oncology - Santa Maria
  - South Pasadena, California, United States, 91030
    - City of Hope South Pasadena
  - Truckee, California, United States, 96161
    - Gene Upshaw Memorial Tahoe Forest Cancer Center
  - Upland, California, United States, 91786
    - City of Hope Upland
  - West Covina, California, United States, 91790
    - City of Hope West Covina
- Colorado
  - Aurora, Colorado, United States, 80045
    - Rocky Mountain Regional VA Medical Center
  - Colorado Springs, Colorado, United States, 80907
    - Penrose-Saint Francis Healthcare
  - Colorado Springs, Colorado, United States, 80907
    - Rocky Mountain Cancer Centers-Penrose
  - Denver, Colorado, United States, 80210
    - Porter Adventist Hospital
  - Durango, Colorado, United States, 81301
    - Mercy Medical Center
  - Durango, Colorado, United States, 81301
    - Southwest Oncology PC
  - Golden, Colorado, United States, 80401
    - Mountain Blue Cancer Care Center
  - Lakewood, Colorado, United States, 80228
    - Saint Anthony Hospital
  - Lakewood, Colorado, United States, 80228
    - Rocky Mountain Cancer Centers-Lakewood
  - Littleton, Colorado, United States, 80122
    - Littleton Adventist Hospital
  - Longmont, Colorado, United States, 80501
    - Longmont United Hospital
  - Longmont, Colorado, United States, 80501
    - Rocky Mountain Cancer Centers-Longmont
  - Parker, Colorado, United States, 80138
    - Parker Adventist Hospital
  - Parker, Colorado, United States, 80138
    - Rocky Mountain Cancer Centers-Parker
  - Pueblo, Colorado, United States, 81004
    - Saint Mary Corwin Medical Center
  - Pueblo, Colorado, United States, 81008
    - Rocky Mountain Cancer Centers - Pueblo
  - Thornton, Colorado, United States, 80260
    - Rocky Mountain Cancer Centers-Thornton
- Connecticut
  - Derby, Connecticut, United States, 06418
    - Smilow Cancer Hospital-Derby Care Center
  - Fairfield, Connecticut, United States, 06824
    - Smilow Cancer Hospital Care Center-Fairfield
  - Guilford, Connecticut, United States, 06437
    - Smilow Cancer Hospital Care Center - Guiford
  - Hartford, Connecticut, United States, 06105
    - Smilow Cancer Hospital Care Center at Saint Francis
  - New Haven, Connecticut, United States, 06520
    - Yale University
  - New Haven, Connecticut, United States, 06510
    - Smilow Cancer Center/Yale-New Haven Hospital
  - North Haven, Connecticut, United States, 06473
    - Yale-New Haven Hospital North Haven Medical Center
  - Orange, Connecticut, United States, 06477
    - Smilow Cancer Hospital-Orange Care Center
  - Torrington, Connecticut, United States, 06790
    - Smilow Cancer Hospital-Torrington Care Center
  - Trumbull, Connecticut, United States, 06611
    - Smilow Cancer Hospital Care Center-Trumbull
  - Waterbury, Connecticut, United States, 06708
    - Smilow Cancer Hospital-Waterbury Care Center
  - Waterford, Connecticut, United States, 06385
    - Smilow Cancer Hospital Care Center - Waterford
- Delaware
  - Frankford, Delaware, United States, 19945
    - Beebe South Coastal Health Campus
  - Lewes, Delaware, United States, 19958
    - Beebe Medical Center
  - Newark, Delaware, United States, 19713
    - Helen F Graham Cancer Center
  - Newark, Delaware, United States, 19713
    - Delaware Clinical and Laboratory Physicians PA
  - Newark, Delaware, United States, 19713
    - Medical Oncology Hematology Consultants PA
  - Newark, Delaware, United States, 19718
    - Christiana Care Health System-Christiana Hospital
  - Rehoboth Beach, Delaware, United States, 19971
    - Beebe Health Campus
  - Seaford, Delaware, United States, 19973
    - TidalHealth Nanticoke / Allen Cancer Center
  - Wilmington, Delaware, United States, 19801
    - Christiana Care Health System-Wilmington Hospital
- District of Columbia
  - Washington, District of Columbia, United States, 20016
    - Sibley Memorial Hospital
- Florida
  - Altamonte Springs, Florida, United States, 32701
    - AdventHealth Altamonte
  - Aventura, Florida, United States, 33180
    - Mount Sinai Comprehensive Cancer Center at Aventura
  - Celebration, Florida, United States, 34747
    - AdventHealth Celebration
  - Fort Myers, Florida, United States, 33905
    - Regional Cancer Center-Lee Memorial Health System
  - Jacksonville, Florida, United States, 32224-9980
    - Mayo Clinic in Florida
  - Kissimmee, Florida, United States, 34744
    - AdventHealth Kissimmee
  - Miami Beach, Florida, United States, 33140
    - Mount Sinai Medical Center
  - Orlando, Florida, United States, 32803
    - AdventHealth Orlando
  - Orlando, Florida, United States, 32803
    - AdventHealth Medical Group Urology at Orlando
  - Orlando, Florida, United States, 32822
    - AdventHealth East Orlando
  - Winter Park, Florida, United States, 32792
    - AdventHealth Winter Park
- Hawaii
  - 'Aiea, Hawaii, United States, 96701
    - Hawaii Cancer Care - Savio
  - 'Aiea, Hawaii, United States, 96701
    - Pali Momi Medical Center
  - 'Aiea, Hawaii, United States, 96701
    - Queen's Cancer Center - Pearlridge
  - 'Aiea, Hawaii, United States, 96701
    - The Cancer Center of Hawaii-Pali Momi
  - Honolulu, Hawaii, United States, 96813
    - Queen's Medical Center
  - Honolulu, Hawaii, United States, 96817
    - The Cancer Center of Hawaii-Liliha
  - Honolulu, Hawaii, United States, 96813
    - Queen's Cancer Cenrer - POB I
  - Honolulu, Hawaii, United States, 96813
    - Straub Clinic and Hospital
  - Honolulu, Hawaii, United States, 96813
    - University of Hawaii Cancer Center
  - Honolulu, Hawaii, United States, 96817
    - Hawaii Cancer Care Inc-Liliha
  - Honolulu, Hawaii, United States, 96817
    - Kuakini Medical Center
  - Honolulu, Hawaii, United States, 96817
    - Queen's Cancer Center - Kuakini
  - Honolulu, Hawaii, United States, 96826
    - Kapiolani Medical Center for Women and Children
  - Honolulu, Hawaii, United States, 96813
    - Island Urology
  - Honolulu, Hawaii, United States, 96813
    - Hawaii Cancer Care Inc-POB II
  - Lihue, Hawaii, United States, 96766
    - Wilcox Memorial Hospital and Kauai Medical Clinic
- Idaho
  - Boise, Idaho, United States, 83706
    - Saint Alphonsus Cancer Care Center-Boise
  - Boise, Idaho, United States, 83712
    - Saint Luke's Mountain States Tumor Institute
  - Caldwell, Idaho, United States, 83605
    - Saint Alphonsus Cancer Care Center-Caldwell
  - Coeur d'Alene, Idaho, United States, 83814
    - Kootenai Medical Center
  - Emmett, Idaho, United States, 83617
    - Walter Knox Memorial Hospital
  - Fruitland, Idaho, United States, 83619
    - Saint Luke's Cancer Institute - Fruitland
  - Meridian, Idaho, United States, 83642
    - Idaho Urologic Institute-Meridian
  - Meridian, Idaho, United States, 83642
    - Saint Luke's Cancer Institute - Meridian
  - Nampa, Idaho, United States, 83686
    - Saint Alphonsus Medical Center-Nampa
  - Nampa, Idaho, United States, 83686
    - Saint Luke's Cancer Institute - Nampa
  - Post Falls, Idaho, United States, 83854
    - Kootenai Cancer Center
  - Sandpoint, Idaho, United States, 83864
    - Kootenai Cancer Clinic
  - Twin Falls, Idaho, United States, 83301
    - Saint Luke's Cancer Institute - Twin Falls
- Illinois
  - Aurora, Illinois, United States, 60504
    - Rush - Copley Medical Center
  - Bloomington, Illinois, United States, 61704
    - Illinois CancerCare-Bloomington
  - Canton, Illinois, United States, 61520
    - Illinois CancerCare-Canton
  - Carbondale, Illinois, United States, 62902
    - Memorial Hospital of Carbondale
  - Carterville, Illinois, United States, 62918
    - SIH Cancer Institute
  - Carthage, Illinois, United States, 62321
    - Illinois CancerCare-Carthage
  - Centralia, Illinois, United States, 62801
    - Centralia Oncology Clinic
  - Chicago, Illinois, United States, 60611
    - Northwestern University
  - Chicago, Illinois, United States, 60612
    - University of Illinois
  - Danville, Illinois, United States, 61832
    - Carle on Vermilion
  - DeKalb, Illinois, United States, 60115
    - Northwestern Medicine Cancer Center Kishwaukee
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital
  - Decatur, Illinois, United States, 62526
    - Cancer Care Specialists of Illinois - Decatur
  - Dixon, Illinois, United States, 61021
    - Illinois CancerCare-Dixon
  - Effingham, Illinois, United States, 62401
    - Crossroads Cancer Center
  - Effingham, Illinois, United States, 62401
    - Carle Physician Group-Effingham
  - Eureka, Illinois, United States, 61530
    - Illinois CancerCare-Eureka
  - Galesburg, Illinois, United States, 61401
    - Western Illinois Cancer Treatment Center
  - Galesburg, Illinois, United States, 61401
    - Illinois CancerCare-Galesburg
  - Geneva, Illinois, United States, 60134
    - Northwestern Medicine Cancer Center Delnor
  - Joliet, Illinois, United States, 60435
    - Joliet Oncology-Hematology Associates Limited
  - Kewanee, Illinois, United States, 61443
    - Illinois CancerCare-Kewanee Clinic
  - Lake Forest, Illinois, United States, 60045
    - Northwestern Medicine Lake Forest Hospital
  - Macomb, Illinois, United States, 61455
    - Illinois CancerCare-Macomb
  - Mattoon, Illinois, United States, 61938
    - Carle Physician Group-Mattoon/Charleston
  - Mount Vernon, Illinois, United States, 62864
    - Good Samaritan Regional Health Center
  - O'Fallon, Illinois, United States, 62269
    - Cancer Care Center of O'Fallon
  - Ottawa, Illinois, United States, 61350
    - Illinois CancerCare-Ottawa Clinic
  - Pekin, Illinois, United States, 61554
    - Illinois CancerCare-Pekin
  - Pekin, Illinois, United States, 61554
    - OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
  - Peoria, Illinois, United States, 61636
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, United States, 61637
    - OSF Saint Francis Medical Center
  - Peoria, Illinois, United States, 61615
    - Illinois CancerCare-Peoria
  - Peoria, Illinois, United States, 61615
    - OSF Saint Francis Radiation Oncology at Peoria Cancer Center
  - Peru, Illinois, United States, 61354
    - Illinois CancerCare-Peru
  - Peru, Illinois, United States, 61354
    - Valley Radiation Oncology
  - Princeton, Illinois, United States, 61356
    - Illinois CancerCare-Princeton
  - Silvis, Illinois, United States, 61282
    - Genesis Cancer Center - Silvis
  - Springfield, Illinois, United States, 62781
    - Memorial Medical Center
  - Springfield, Illinois, United States, 62702
    - Southern Illinois University School of Medicine
  - Springfield, Illinois, United States, 62702
    - Springfield Clinic
  - Swansea, Illinois, United States, 62226
    - Southwest Illinois Health Services LLP
  - Urbana, Illinois, United States, 61801
    - Carle Cancer Center
  - Urbana, Illinois, United States, 61801
    - The Carle Foundation Hospital
  - Warrenville, Illinois, United States, 60555
    - Northwestern Medicine Cancer Center Warrenville
  - Yorkville, Illinois, United States, 60560
    - Rush-Copley Healthcare Center
- Indiana
  - Carmel, Indiana, United States, 46032
    - IU Health North Hospital
  - Indianapolis, Indiana, United States, 46237
    - Franciscan Health Indianapolis
  - Indianapolis, Indiana, United States, 46202
    - Indiana University/Melvin and Bren Simon Cancer Center
  - Lafayette, Indiana, United States, 47905
    - Franciscan Saint Elizabeth Health - Lafayette East
  - Michigan City, Indiana, United States, 46360
    - Woodland Cancer Care Center
  - Mooresville, Indiana, United States, 46158
    - Franciscan Health Mooresville
  - Richmond, Indiana, United States, 47374
    - Reid Health
  - Terre Haute, Indiana, United States, 47804
    - Union Hospital
- Iowa
  - Ames, Iowa, United States, 50010
    - McFarland Clinic PC - Ames
  - Ames, Iowa, United States, 50010
    - Mary Greeley Medical Center
  - Boone, Iowa, United States, 50036
    - McFarland Clinic PC-Boone
  - Clive, Iowa, United States, 50325
    - Mercy Cancer Center-West Lakes
  - Clive, Iowa, United States, 50325
    - Medical Oncology and Hematology Associates-West Des Moines
  - Council Bluffs, Iowa, United States, 51503
    - Alegent Health Mercy Hospital
  - Creston, Iowa, United States, 50801
    - Greater Regional Medical Center
  - Davenport, Iowa, United States, 52803
    - Genesis Medical Center - East Campus
  - Davenport, Iowa, United States, 52804
    - Genesis Cancer Care Institute
  - Davenport, Iowa, United States, 52807
    - Iowa Cancer Specialists
  - Des Moines, Iowa, United States, 50309
    - Iowa Methodist Medical Center
  - Des Moines, Iowa, United States, 50314
    - Mercy Medical Center - Des Moines
  - Des Moines, Iowa, United States, 50309
    - Medical Oncology and Hematology Associates-Des Moines
  - Des Moines, Iowa, United States, 50314
    - Broadlawns Medical Center
  - Des Moines, Iowa, United States, 50316
    - Iowa Lutheran Hospital
  - Des Moines, Iowa, United States, 50314
    - Medical Oncology and Hematology Associates-Laurel
  - Fort Dodge, Iowa, United States, 50501
    - McFarland Clinic PC-Trinity Cancer Center
  - Fort Dodge, Iowa, United States, 50501
    - Trinity Regional Medical Center
  - Jefferson, Iowa, United States, 50129
    - McFarland Clinic PC-Jefferson
  - Marshalltown, Iowa, United States, 50158
    - McFarland Clinic PC-Marshalltown
  - Sioux City, Iowa, United States, 51101
    - Siouxland Regional Cancer Center
  - West Des Moines, Iowa, United States, 50266-7700
    - Methodist West Hospital
  - West Des Moines, Iowa, United States, 50266
    - Mercy Medical Center-West Lakes
- Kansas
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
  - Wichita, Kansas, United States, 67208
    - Cancer Center of Kansas-Wichita Medical Arts Tower
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas - Wichita
- Kentucky
  - Bardstown, Kentucky, United States, 40004
    - Flaget Memorial Hospital
  - Corbin, Kentucky, United States, 40701
    - Commonwealth Cancer Center-Corbin
  - Lexington, Kentucky, United States, 40504
    - Saint Joseph Radiation Oncology Resource Center
  - Lexington, Kentucky, United States, 40509
    - Saint Joseph Hospital East
  - London, Kentucky, United States, 40741
    - Saint Joseph London
  - Louisville, Kentucky, United States, 40202
    - The James Graham Brown Cancer Center at University of Louisville
  - Louisville, Kentucky, United States, 40202
    - Jewish Hospital
  - Louisville, Kentucky, United States, 40215
    - Saints Mary and Elizabeth Hospital
  - Louisville, Kentucky, United States, 40245
    - Jewish Hospital Medical Center Northeast
  - Shepherdsville, Kentucky, United States, 40165
    - Jewish Hospital Medical Center South
- Louisiana
  - Baton Rouge, Louisiana, United States, 70805
    - LSU Health Baton Rouge-North Clinic
  - Baton Rouge, Louisiana, United States, 70809
    - Louisiana Hematology Oncology Associates LLC
  - Baton Rouge, Louisiana, United States, 70809
    - Mary Bird Perkins Cancer Center
  - Baton Rouge, Louisiana, United States, 70809
    - Our Lady of the Lake Physicians Group - Medical Oncology
  - Baton Rouge, Louisiana, United States, 70816
    - Medical Center of Baton Rouge
  - Baton Rouge, Louisiana, United States, 70836
    - Ochsner High Grove
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Medical Center Jefferson
  - New Orleans, Louisiana, United States, 70112
    - Louisiana State University Health Science Center
- Maine
  - Augusta, Maine, United States, 04330
    - Harold Alfond Center for Cancer Care
  - Bangor, Maine, United States, 04401
    - Eastern Maine Medical Center
  - Belfast, Maine, United States, 04915
    - Waldo County General Hospital
  - Biddeford, Maine, United States, 04005
    - MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
  - Brewer, Maine, United States, 04412
    - Lafayette Family Cancer Center-EMMC
  - Norway, Maine, United States, 04268
    - Stephens Memorial Hospital
  - Rockport, Maine, United States, 04856
    - Penobscot Bay Medical Center
  - Sanford, Maine, United States, 04073
    - MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
  - South Portland, Maine, United States, 04106
    - Maine Medical Partners - South Portland
- Maryland
  - Baltimore, Maryland, United States, 21287
    - Johns Hopkins University/Sidney Kimmel Cancer Center
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Beth Israel Deaconess Medical Center
  - Boston, Massachusetts, United States, 02215
    - Dana-Farber Cancer Institute
  - Lowell, Massachusetts, United States, 01854
    - Lowell General Hospital
  - Worcester, Massachusetts, United States, 01655
    - UMass Memorial Medical Center - University Campus
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - University of Michigan Comprehensive Cancer Center
  - Battle Creek, Michigan, United States, 49017
    - Bronson Battle Creek
  - Bay City, Michigan, United States, 48706
    - McLaren Cancer Institute-Bay City
  - Brownstown, Michigan, United States, 48183
    - Henry Ford Cancer Institute-Downriver
  - Clarkston, Michigan, United States, 48346
    - McLaren Cancer Institute-Clarkston
  - Clinton Township, Michigan, United States, 48038
    - Henry Ford Macomb Hospital-Clinton Township
  - Dearborn, Michigan, United States, 48126
    - Henry Ford Medical Center-Fairlane
  - Detroit, Michigan, United States, 48202
    - Henry Ford Hospital
  - Detroit, Michigan, United States, 48201
    - Wayne State University/Karmanos Cancer Institute
  - Farmington Hills, Michigan, United States, 48334
    - Weisberg Cancer Treatment Center
  - Flint, Michigan, United States, 48532
    - McLaren Cancer Institute-Flint
  - Flint, Michigan, United States, 48532
    - Singh and Arora Hematology Oncology PC
  - Grand Rapids, Michigan, United States, 49503
    - Spectrum Health at Butterworth Campus
  - Grand Rapids, Michigan, United States, 49503
    - Helen DeVos Children's Hospital at Spectrum Health
  - Grand Rapids, Michigan, United States, 49503
    - Mercy Health Saint Mary's
  - Jackson, Michigan, United States, 49201
    - Allegiance Health
  - Kalamazoo, Michigan, United States, 49007
    - West Michigan Cancer Center
  - Kalamazoo, Michigan, United States, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, United States, 49048
    - Borgess Medical Center
  - Lansing, Michigan, United States, 48910
    - McLaren-Greater Lansing
  - Lansing, Michigan, United States, 48912
    - Mid-Michigan Physicians-Lansing
  - Lapeer, Michigan, United States, 48446
    - McLaren Cancer Institute-Lapeer Region
  - Mount Clemens, Michigan, United States, 48043
    - McLaren Cancer Institute-Macomb
  - Mount Pleasant, Michigan, United States, 48858
    - McLaren Cancer Institute-Central Michigan
  - Muskegon, Michigan, United States, 49444
    - Mercy Health Mercy Campus
  - Niles, Michigan, United States, 49120
    - Lakeland Hospital Niles
  - Norton Shores, Michigan, United States, 49444
    - Cancer and Hematology Centers of Western Michigan - Norton Shores
  - Novi, Michigan, United States, 48374
    - Ascension Providence Hospitals - Novi
  - Novi, Michigan, United States, 48377
    - Henry Ford Medical Center-Columbus
  - Port Huron, Michigan, United States, 48060
    - McLaren-Port Huron
  - Port Huron, Michigan, United States, 48060
    - Lake Huron Medical Center
  - Port Huron, Michigan, United States, 48060
    - Huron Medical Center PC
  - Reed City, Michigan, United States, 49677
    - Spectrum Health Reed City Hospital
  - Saint Joseph, Michigan, United States, 49085
    - Lakeland Medical Center Saint Joseph
  - Saint Joseph, Michigan, United States, 49085
    - Marie Yeager Cancer Center
  - Shelby, Michigan, United States, 48315
    - Henry Ford Macomb Health Center - Shelby Township
  - Southfield, Michigan, United States, 48075
    - Ascension Providence Hospitals - Southfield
  - Traverse City, Michigan, United States, 49684
    - Munson Medical Center
  - West Bloomfield, Michigan, United States, 48322
    - Henry Ford West Bloomfield Hospital
  - Wyoming, Michigan, United States, 49519
    - Metro Health Hospital
- Minnesota
  - Aitkin, Minnesota, United States, 56431
    - Riverwood Healthcare Center
  - Bemidji, Minnesota, United States, 56601
    - Sanford Joe Lueken Cancer Center
  - Brainerd, Minnesota, United States, 56401
    - Essentia Health Saint Joseph's Medical Center
  - Burnsville, Minnesota, United States, 55337
    - Fairview Ridges Hospital
  - Burnsville, Minnesota, United States, 55337
    - Minnesota Oncology - Burnsville
  - Cambridge, Minnesota, United States, 55008
    - Cambridge Medical Center
  - Coon Rapids, Minnesota, United States, 55433
    - Mercy Hospital
  - Deer River, Minnesota, United States, 56636
    - Essentia Health - Deer River Clinic
  - Detroit Lakes, Minnesota, United States, 56501
    - Essentia Health Saint Mary's - Detroit Lakes Clinic
  - Duluth, Minnesota, United States, 55805
    - Essentia Health Cancer Center
  - Duluth, Minnesota, United States, 55805
    - Essentia Health Saint Mary's Medical Center
  - Duluth, Minnesota, United States, 55805
    - Miller-Dwan Hospital
  - Edina, Minnesota, United States, 55435
    - Fairview Southdale Hospital
  - Fergus Falls, Minnesota, United States, 56537
    - Lake Region Healthcare Corporation-Cancer Care
  - Fosston, Minnesota, United States, 56542
    - Essentia Health - Fosston
  - Fridley, Minnesota, United States, 55432
    - Unity Hospital
  - Hibbing, Minnesota, United States, 55746
    - Essentia Health Hibbing Clinic
  - Maple Grove, Minnesota, United States, 55369
    - Fairview Clinics and Surgery Center Maple Grove
  - Maplewood, Minnesota, United States, 55109
    - Saint John's Hospital - Healtheast
  - Maplewood, Minnesota, United States, 55109
    - Minnesota Oncology Hematology PA-Maplewood
  - Minneapolis, Minnesota, United States, 55415
    - Hennepin County Medical Center
  - Minneapolis, Minnesota, United States, 55407
    - Abbott-Northwestern Hospital
  - Minneapolis, Minnesota, United States, 55454
    - Health Partners Inc
  - Monticello, Minnesota, United States, 55362
    - Monticello Cancer Center
  - New Ulm, Minnesota, United States, 56073
    - New Ulm Medical Center
  - Park Rapids, Minnesota, United States, 56470
    - Essentia Health - Park Rapids
  - Princeton, Minnesota, United States, 55371
    - Fairview Northland Medical Center
  - Robbinsdale, Minnesota, United States, 55422
    - North Memorial Medical Health Center
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic in Rochester
  - Saint Louis Park, Minnesota, United States, 55416
    - Park Nicollet Clinic - Saint Louis Park
  - Saint Paul, Minnesota, United States, 55101
    - Regions Hospital
  - Saint Paul, Minnesota, United States, 55102
    - United Hospital
  - Sandstone, Minnesota, United States, 55072
    - Essentia Health Sandstone
  - Shakopee, Minnesota, United States, 55379
    - Saint Francis Regional Medical Center
  - Stillwater, Minnesota, United States, 55082
    - Lakeview Hospital
  - Thief River Falls, Minnesota, United States, 56701
    - Sanford Thief River Falls Medical Center
  - Virginia, Minnesota, United States, 55792
    - Essentia Health Virginia Clinic
  - Waconia, Minnesota, United States, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, United States, 56201
    - Rice Memorial Hospital
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology Hematology PA-Woodbury
  - Worthington, Minnesota, United States, 56187
    - Sanford Cancer Center Worthington
  - Wyoming, Minnesota, United States, 55092
    - Fairview Lakes Medical Center
- Mississippi
  - Columbus, Mississippi, United States, 39705
    - Baptist Memorial Hospital and Cancer Center-Golden Triangle
  - Corinth, Mississippi, United States, 38834
    - The West Clinic - Corinth
  - Grenada, Mississippi, United States, 38901
    - Baptist Cancer Center-Grenada
  - Gulfport, Mississippi, United States, 39502
    - Gulfport Memorial Hospital
  - New Albany, Mississippi, United States, 38652
    - Baptist Memorial Hospital and Cancer Center-Union County
  - Oxford, Mississippi, United States, 38655
    - Baptist Memorial Hospital and Cancer Center-Oxford
  - Southaven, Mississippi, United States, 38671
    - The West Clinic - Southaven
  - Southhaven, Mississippi, United States, 38671
    - Baptist Memorial Hospital and Cancer Center-Desoto
- Missouri
  - Ballwin, Missouri, United States, 63011
    - Saint Louis Cancer and Breast Institute-Ballwin
  - Bonne Terre, Missouri, United States, 63628
    - Parkland Health Center-Bonne Terre
  - Branson, Missouri, United States, 65616
    - Cox Cancer Center Branson
  - Cape Girardeau, Missouri, United States, 63703
    - Saint Francis Medical Center
  - Cape Girardeau, Missouri, United States, 63703
    - Southeast Cancer Center
  - Chesterfield, Missouri, United States, 63017
    - Saint Luke's Hospital
  - Creve Coeur, Missouri, United States, 63141
    - Siteman Cancer Center at West County Hospital
  - Farmington, Missouri, United States, 63640
    - Parkland Health Center - Farmington
  - Jefferson City, Missouri, United States, 65109
    - Capital Region Southwest Campus
  - Joplin, Missouri, United States, 64804
    - Freeman Health System
  - Joplin, Missouri, United States, 64804
    - Mercy Hospital Joplin
  - Rolla, Missouri, United States, 65401
    - Delbert Day Cancer Institute at PCRMC
  - Rolla, Missouri, United States, 65401
    - Mercy Clinic-Rolla-Cancer and Hematology
  - Saint Joseph, Missouri, United States, 64506
    - Heartland Regional Medical Center
  - Saint Louis, Missouri, United States, 63110
    - Washington University School of Medicine
  - Saint Louis, Missouri, United States, 63131
    - Missouri Baptist Medical Center
  - Saint Louis, Missouri, United States, 63141
    - Mercy Hospital Saint Louis
  - Saint Louis, Missouri, United States, 63128
    - Mercy Hospital South
  - Saint Louis, Missouri, United States, 63129
    - Siteman Cancer Center-South County
  - Saint Louis, Missouri, United States, 63136
    - Siteman Cancer Center at Christian Hospital
  - Saint Louis, Missouri, United States, 63109
    - Saint Louis Cancer and Breast Institute-South City
  - Saint Peters, Missouri, United States, 63376
    - Siteman Cancer Center at Saint Peters Hospital
  - Sainte Genevieve, Missouri, United States, 63670
    - Sainte Genevieve County Memorial Hospital
  - Springfield, Missouri, United States, 65807
    - CoxHealth South Hospital
  - Springfield, Missouri, United States, 65804
    - Mercy Hospital Springfield
  - Sullivan, Missouri, United States, 63080
    - Missouri Baptist Sullivan Hospital
  - Sunset Hills, Missouri, United States, 63127
    - Missouri Baptist Outpatient Center-Sunset Hills
  - Washington, Missouri, United States, 63090
    - Mercy Hospital Washington
- Montana
  - Anaconda, Montana, United States, 59711
    - Community Hospital of Anaconda
  - Billings, Montana, United States, 59101
    - Billings Clinic Cancer Center
  - Bozeman, Montana, United States, 59715
    - Bozeman Deaconess Hospital
  - Great Falls, Montana, United States, 59405
    - Great Falls Clinic
  - Great Falls, Montana, United States, 59405
    - Benefis Healthcare- Sletten Cancer Institute
  - Helena, Montana, United States, 59601
    - Saint Peter's Community Hospital
  - Kalispell, Montana, United States, 59901
    - Kalispell Regional Medical Center
  - Missoula, Montana, United States, 59804
    - Community Medical Hospital
  - Missoula, Montana, United States, 59802
    - Saint Patrick Hospital - Community Hospital
- Nebraska
  - Grand Island, Nebraska, United States, 68803
    - CHI Health Saint Francis
  - Kearney, Nebraska, United States, 68847
    - CHI Health Good Samaritan
  - Kearney, Nebraska, United States, 68845
    - Heartland Hematology and Oncology
  - Lincoln, Nebraska, United States, 68510
    - Saint Elizabeth Regional Medical Center
  - Omaha, Nebraska, United States, 68114
    - Nebraska Methodist Hospital
  - Omaha, Nebraska, United States, 68124
    - Alegent Health Bergan Mercy Medical Center
  - Omaha, Nebraska, United States, 68122
    - Alegent Health Immanuel Medical Center
  - Omaha, Nebraska, United States, 68130
    - Alegent Health Lakeside Hospital
  - Omaha, Nebraska, United States, 68131
    - Creighton University Medical Center
  - Omaha, Nebraska, United States, 68122
    - Hematology and Oncology Consultants PC
  - Papillion, Nebraska, United States, 68046
    - Midlands Community Hospital
- Nevada
  - Carson City, Nevada, United States, 89703
    - Carson Tahoe Regional Medical Center
  - Henderson, Nevada, United States, 89052
    - Comprehensive Cancer Centers of Nevada - Henderson
  - Henderson, Nevada, United States, 89052
    - OptumCare Cancer Care at Seven Hills
  - Henderson, Nevada, United States, 89052
    - Cancer and Blood Specialists-Henderson
  - Henderson, Nevada, United States, 89052
    - Las Vegas Cancer Center-Henderson
  - Henderson, Nevada, United States, 89074
    - Comprehensive Cancer Centers of Nevada-Southeast Henderson
  - Henderson, Nevada, United States, 89074
    - 21st Century Oncology-Henderson
  - Henderson, Nevada, United States, 89052
    - Comprehensive Cancer Centers of Nevada-Horizon Ridge
  - Henderson, Nevada, United States, 89074
    - Las Vegas Urology - Green Valley
  - Henderson, Nevada, United States, 89074
    - Las Vegas Urology - Pebble
  - Henderson, Nevada, United States, 89074
    - Urology Specialists of Nevada - Green Valley
  - Las Vegas, Nevada, United States, 89144
    - Summerlin Hospital Medical Center
  - Las Vegas, Nevada, United States, 89109
    - Sunrise Hospital and Medical Center
  - Las Vegas, Nevada, United States, 89106
    - Radiation Oncology Centers of Nevada Central
  - Las Vegas, Nevada, United States, 89119
    - Radiation Oncology Centers of Nevada Southeast
  - Las Vegas, Nevada, United States, 89128
    - Comprehensive Cancer Centers of Nevada - Northwest
  - Las Vegas, Nevada, United States, 89128
    - OptumCare Cancer Care at MountainView
  - Las Vegas, Nevada, United States, 89135
    - Alliance for Childhood Diseases/Cure 4 the Kids Foundation
  - Las Vegas, Nevada, United States, 89144
    - Comprehensive Cancer Centers of Nevada - Town Center
  - Las Vegas, Nevada, United States, 89144
    - Comprehensive Cancer Centers of Nevada-Summerlin
  - Las Vegas, Nevada, United States, 89148
    - Comprehensive Cancer Centers of Nevada
  - Las Vegas, Nevada, United States, 89148
    - OptumCare Cancer Care at Fort Apache
  - Las Vegas, Nevada, United States, 89169
    - Comprehensive Cancer Centers of Nevada - Central Valley
  - Las Vegas, Nevada, United States, 89102
    - University Medical Center of Southern Nevada
  - Las Vegas, Nevada, United States, 89106
    - Cancer and Blood Specialists-Shadow
  - Las Vegas, Nevada, United States, 89109
    - HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
  - Las Vegas, Nevada, United States, 89113
    - HealthCare Partners Medical Group Oncology/Hematology-San Martin
  - Las Vegas, Nevada, United States, 89128
    - Cancer and Blood Specialists-Tenaya
  - Las Vegas, Nevada, United States, 89128
    - HealthCare Partners Medical Group Oncology/Hematology-Tenaya
  - Las Vegas, Nevada, United States, 89148-2405
    - Las Vegas Cancer Center-Medical Center
  - Las Vegas, Nevada, United States, 89149
    - HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
  - Las Vegas, Nevada, United States, 89109
    - 21st Century Oncology
  - Las Vegas, Nevada, United States, 89128
    - 21st Century Oncology-Vegas Tenaya
  - Las Vegas, Nevada, United States, 89148
    - 21st Century Oncology-Fort Apache
  - Las Vegas, Nevada, United States, 89128
    - Ann M Wierman MD LTD
  - Las Vegas, Nevada, United States, 89074
    - Las Vegas Urology - Pecos
  - Las Vegas, Nevada, United States, 89102
    - Desert West Surgery
  - Las Vegas, Nevada, United States, 89102
    - OptumCare Cancer Care at Oakey
  - Las Vegas, Nevada, United States, 89103
    - Hope Cancer Care of Nevada
  - Las Vegas, Nevada, United States, 89106
    - Urology Specialists of Nevada - Central
  - Las Vegas, Nevada, United States, 89113
    - Las Vegas Prostate Cancer Center
  - Las Vegas, Nevada, United States, 89113
    - Las Vegas Urology - Sunset
  - Las Vegas, Nevada, United States, 89128
    - Las Vegas Urology - Cathedral Rock
  - Las Vegas, Nevada, United States, 89128
    - Las Vegas Urology - Smoke Ranch
  - Las Vegas, Nevada, United States, 89128
    - Urology Specialists of Nevada - Northwest
  - Las Vegas, Nevada, United States, 89148
    - Urology Specialists of Nevada - Southwest
  - Las Vegas, Nevada, United States, 89169
    - University Cancer Center
  - Pahrump, Nevada, United States, 89048
    - Hope Cancer Care of Nevada-Pahrump
  - Reno, Nevada, United States, 89502
    - Renown Regional Medical Center
  - Reno, Nevada, United States, 89503
    - Saint Mary's Regional Medical Center
  - Reno, Nevada, United States, 89509
    - Radiation Oncology Associates
- New Hampshire
  - Lebanon, New Hampshire, United States, 03756
    - Dartmouth Hitchcock Medical Center
- New Jersey
  - Basking Ridge, New Jersey, United States, 07920
    - Memorial Sloan Kettering Basking Ridge
  - Middletown, New Jersey, United States, 07748
    - Memorial Sloan Kettering Monmouth
  - Montvale, New Jersey, United States, 07645
    - Memorial Sloan Kettering Bergen
  - New Brunswick, New Jersey, United States, 08903
    - Rutgers Cancer Institute of New Jersey
  - Teaneck, New Jersey, United States, 07666
    - Holy Name Hospital
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
    - University of New Mexico Cancer Center
  - Albuquerque, New Mexico, United States, 87102
    - Lovelace Medical Center-Saint Joseph Square
  - Albuquerque, New Mexico, United States, 87109
    - New Mexico Oncology Hematology Consultants
  - Albuquerque, New Mexico, United States, 87110
    - Presbyterian Kaseman Hospital
  - Las Cruces, New Mexico, United States, 88011
    - Memorial Medical Center - Las Cruces
  - Rio Rancho, New Mexico, United States, 87124
    - Presbyterian Rust Medical Center/Jorgensen Cancer Center
- New York
  - Bronx, New York, United States, 10468
    - James J Peters VA Medical Center
  - Buffalo, New York, United States, 14263
    - Roswell Park Cancer Institute
  - Commack, New York, United States, 11725
    - Memorial Sloan Kettering Commack
  - Glens Falls, New York, United States, 12801
    - Glens Falls Hospital
  - Harrison, New York, United States, 10604
    - Memorial Sloan Kettering Westchester
  - New York, New York, United States, 10065
    - Memorial Sloan Kettering Cancer Center
  - New York, New York, United States, 10065
    - NYP/Weill Cornell Medical Center
  - New York, New York, United States, 10016
    - Laura and Isaac Perlmutter Cancer Center at NYU Langone
  - Rochester, New York, United States, 14642
    - University of Rochester
  - Stony Brook, New York, United States, 11794
    - Stony Brook University Medical Center
  - Uniondale, New York, United States, 11553
    - Memorial Sloan Kettering Nassau
- North Carolina
  - Clinton, North Carolina, United States, 28328
    - Southeastern Medical Oncology Center-Clinton
  - Goldsboro, North Carolina, United States, 27534
    - Southeastern Medical Oncology Center-Goldsboro
  - Goldsboro, North Carolina, United States, 27534
    - Wayne Memorial Hospital
  - Hendersonville, North Carolina, United States, 28791
    - Margaret R Pardee Memorial Hospital
  - Jacksonville, North Carolina, United States, 28546
    - Southeastern Medical Oncology Center-Jacksonville
  - Jacksonville, North Carolina, United States, 28546
    - Onslow Memorial Hospital
  - Kenansville, North Carolina, United States, 28349
    - Vidant Oncology-Kenansville
  - Kinston, North Carolina, United States, 28501
    - Vidant Oncology-Kinston
  - Richlands, North Carolina, United States, 28574
    - Vidant Oncology-Richlands
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - Sanford Bismarck Medical Center
  - Fargo, North Dakota, United States, 58122
    - Sanford Roger Maris Cancer Center
  - Fargo, North Dakota, United States, 58103
    - Essentia Health Cancer Center-South University Clinic
  - Fargo, North Dakota, United States, 58122
    - Sanford Broadway Medical Center
  - Fargo, North Dakota, United States, 58103
    - Sanford South University Medical Center
  - Fargo, North Dakota, United States, 58104
    - Sanford Medical Center Fargo
  - Jamestown, North Dakota, United States, 58401
    - Essentia Health - Jamestown Clinic
- Ohio
  - Beachwood, Ohio, United States, 44122
    - UHHS-Chagrin Highlands Medical Center
  - Beavercreek, Ohio, United States, 45431
    - Indu and Raj Soin Medical Center
  - Belpre, Ohio, United States, 45714
    - Strecker Cancer Center-Belpre
  - Boardman, Ohio, United States, 44512
    - Saint Elizabeth Boardman Hospital
  - Canton, Ohio, United States, 44708
    - Mercy Medical Center
  - Canton, Ohio, United States, 44708
    - Hematology and Oncology Associates Inc
  - Centerville, Ohio, United States, 45459
    - Miami Valley Hospital South
  - Centerville, Ohio, United States, 45459
    - Dayton Physicians LLC-Miami Valley South
  - Chardon, Ohio, United States, 44024
    - Geauga Hospital
  - Chillicothe, Ohio, United States, 45601
    - Adena Regional Medical Center
  - Cincinnati, Ohio, United States, 45220
    - Good Samaritan Hospital - Cincinnati
  - Cincinnati, Ohio, United States, 45242
    - Bethesda North Hospital
  - Cincinnati, Ohio, United States, 45236
    - Oncology Hematology Care Inc-Kenwood
  - Cincinnati, Ohio, United States, 45219
    - University of Cincinnati/Barrett Cancer Center
  - Cincinnati, Ohio, United States, 45247
    - TriHealth Cancer Institute-Westside
  - Cincinnati, Ohio, United States, 45255
    - TriHealth Cancer Institute-Anderson
  - Cleveland, Ohio, United States, 44106
    - Case Western Reserve University
  - Cleveland, Ohio, United States, 44109
    - MetroHealth Medical Center
  - Columbus, Ohio, United States, 43214
    - Riverside Methodist Hospital
  - Columbus, Ohio, United States, 43219
    - The Mark H Zangmeister Center
  - Columbus, Ohio, United States, 43214
    - Columbus Oncology and Hematology Associates Inc
  - Columbus, Ohio, United States, 43228
    - Doctors Hospital
  - Columbus, Ohio, United States, 43213
    - Mount Carmel East Hospital
  - Columbus, Ohio, United States, 43215
    - Grant Medical Center
  - Columbus, Ohio, United States, 43222
    - Mount Carmel Health Center West
  - Dayton, Ohio, United States, 45406
    - Good Samaritan Hospital - Dayton
  - Dayton, Ohio, United States, 45409
    - Miami Valley Hospital
  - Dayton, Ohio, United States, 45415
    - Dayton Physician LLC-Miami Valley Hospital North
  - Dayton, Ohio, United States, 45415
    - Miami Valley Hospital North
  - Dayton, Ohio, United States, 45428
    - Dayton Veterans Affairs Medical Center
  - Delaware, Ohio, United States, 43015
    - Delaware Health Center-Grady Cancer Center
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Dublin, Ohio, United States, 43016
    - Dublin Methodist Hospital
  - Elyria, Ohio, United States, 44035
    - Mercy Cancer Center-Elyria
  - Findlay, Ohio, United States, 45840
    - Blanchard Valley Hospital
  - Findlay, Ohio, United States, 45840
    - Armes Family Cancer Center
  - Findlay, Ohio, United States, 45840
    - Orion Cancer Care
  - Franklin, Ohio, United States, 45005-1066
    - Atrium Medical Center-Middletown Regional Hospital
  - Franklin, Ohio, United States, 45005
    - Dayton Physicians LLC-Atrium
  - Gahanna, Ohio, United States, 43230
    - Central Ohio Breast and Endocrine Surgery
  - Greenville, Ohio, United States, 45331
    - Wayne Hospital
  - Greenville, Ohio, United States, 45331
    - Dayton Physicians LLC-Wayne
  - Grove City, Ohio, United States, 43123
    - Mount Carmel Grove City Hospital
  - Kettering, Ohio, United States, 45429
    - Kettering Medical Center
  - Kettering, Ohio, United States, 45409
    - Greater Dayton Cancer Center
  - Kettering, Ohio, United States, 45420
    - First Dayton Cancer Care
  - Lancaster, Ohio, United States, 43130
    - Fairfield Medical Center
  - Mansfield, Ohio, United States, 44903
    - OhioHealth Mansfield Hospital
  - Marietta, Ohio, United States, 45750
    - Marietta Memorial Hospital
  - Marion, Ohio, United States, 43302
    - OhioHealth Marion General Hospital
  - Mayfield Heights, Ohio, United States, 44124
    - UH Seidman Cancer Center at Landerbrook Health Center
  - Mentor, Ohio, United States, 44060
    - UH Seidman Cancer Center at Lake Health Mentor Campus
  - Middleburg Heights, Ohio, United States, 44130
    - UH Seidman Cancer Center at Southwest General Hospital
  - Mount Vernon, Ohio, United States, 43050
    - Knox Community Hospital
  - Newark, Ohio, United States, 43055
    - Licking Memorial Hospital
  - Newark, Ohio, United States, 43055
    - Newark Radiation Oncology
  - Parma, Ohio, United States, 44129
    - University Hospitals Parma Medical Center
  - Portsmouth, Ohio, United States, 45662
    - Southern Ohio Medical Center
  - Ravenna, Ohio, United States, 44266
    - University Hospitals Portage Medical Center
  - Sandusky, Ohio, United States, 44870
    - UH Seidman Cancer Center at Firelands Regional Medical Center
  - Springfield, Ohio, United States, 45505
    - Springfield Regional Medical Center
  - Springfield, Ohio, United States, 45504
    - Springfield Regional Cancer Center
  - Troy, Ohio, United States, 45373
    - Upper Valley Medical Center
  - Troy, Ohio, United States, 45373
    - Dayton Physicians LLC-Upper Valley
  - Wadsworth, Ohio, United States, 44281
    - University Hospitals Sharon Health Center
  - Warren, Ohio, United States, 44484
    - Saint Joseph Warren Hospital
  - West Chester, Ohio, United States, 45069
    - University Pointe
  - Westerville, Ohio, United States, 43081
    - Saint Ann's Hospital
  - Westlake, Ohio, United States, 44145
    - UH Seidman Cancer Center at Saint John Medical Center
  - Westlake, Ohio, United States, 44145
    - UHHS-Westlake Medical Center
  - Youngstown, Ohio, United States, 44501
    - Saint Elizabeth Youngstown Hospital
  - Zanesville, Ohio, United States, 43701
    - Genesis Healthcare System Cancer Care Center
- Oklahoma
  - Lawton, Oklahoma, United States, 73505
    - Cancer Centers of Southwest Oklahoma Research
  - Oklahoma City, Oklahoma, United States, 73104
    - University of Oklahoma Health Sciences Center
  - Oklahoma City, Oklahoma, United States, 73120
    - Mercy Hospital Oklahoma City
  - Tulsa, Oklahoma, United States, 74146
    - Oklahoma Cancer Specialists and Research Institute-Tulsa
  - Tulsa, Oklahoma, United States, 74133
    - Cancer Treatment Centers of America
- Oregon
  - Baker City, Oregon, United States, 97814
    - Saint Alphonsus Medical Center-Baker City
  - Bend, Oregon, United States, 97701
    - Saint Charles Health System
  - Clackamas, Oregon, United States, 97015
    - Clackamas Radiation Oncology Center
  - Clackamas, Oregon, United States, 97015
    - Providence Cancer Institute Clackamas Clinic
  - Coos Bay, Oregon, United States, 97420
    - Bay Area Hospital
  - Corvallis, Oregon, United States, 97330
    - Good Samaritan Hospital
  - Gresham, Oregon, United States, 97030
    - Legacy Mount Hood Medical Center
  - Newberg, Oregon, United States, 97132
    - Providence Newberg Medical Center
  - Ontario, Oregon, United States, 97914
    - Saint Alphonsus Medical Center-Ontario
  - Portland, Oregon, United States, 97239
    - Oregon Health and Science University
  - Portland, Oregon, United States, 97210
    - Legacy Good Samaritan Hospital and Medical Center
  - Portland, Oregon, United States, 97213
    - Providence Portland Medical Center
  - Portland, Oregon, United States, 97225
    - Providence Saint Vincent Medical Center
  - Redmond, Oregon, United States, 97756
    - Saint Charles Health System-Redmond
  - Tualatin, Oregon, United States, 97062
    - Legacy Meridian Park Hospital
- Pennsylvania
  - Chadds Ford, Pennsylvania, United States, 19317
    - Christiana Care Health System-Concord Health Center
  - Philadelphia, Pennsylvania, United States, 19107
    - Thomas Jefferson University Hospital
  - Philadelphia, Pennsylvania, United States, 19124
    - Eastern Regional Medical Center
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - AnMed Health Cancer Center
  - Boiling Springs, South Carolina, United States, 29316
    - Prisma Health Cancer Institute - Spartanburg
  - Easley, South Carolina, United States, 29640
    - Prisma Health Cancer Institute - Easley
  - Gaffney, South Carolina, United States, 29341
    - Gibbs Cancer Center-Gaffney
  - Greenville, South Carolina, United States, 29605
    - Prisma Health Cancer Institute - Faris
  - Greenville, South Carolina, United States, 29607
    - Saint Francis Cancer Center
  - Greenville, South Carolina, United States, 29615
    - Prisma Health Cancer Institute - Eastside
  - Greenville, South Carolina, United States, 29605
    - Prisma Health Cancer Institute - Butternut
  - Greenville, South Carolina, United States, 29601
    - Saint Francis Hospital
  - Greenville, South Carolina, United States, 29605
    - Prisma Health Greenville Memorial Hospital
  - Greer, South Carolina, United States, 29650
    - Prisma Health Cancer Institute - Greer
  - Greer, South Carolina, United States, 29651
    - Gibbs Cancer Center-Pelham
  - Seneca, South Carolina, United States, 29672
    - Prisma Health Cancer Institute - Seneca
  - Spartanburg, South Carolina, United States, 29303
    - Spartanburg Medical Center
  - Union, South Carolina, United States, 29379
    - MGC Hematology Oncology-Union
- South Dakota
  - Sioux Falls, South Dakota, United States, 57117-5134
    - Sanford USD Medical Center - Sioux Falls
  - Sioux Falls, South Dakota, United States, 57104
    - Sanford Cancer Center Oncology Clinic
- Tennessee
  - Bristol, Tennessee, United States, 37620
    - Wellmont Bristol Regional Medical Center
  - Chattanooga, Tennessee, United States, 37404
    - Memorial Hospital
  - Collierville, Tennessee, United States, 38017
    - Baptist Memorial Hospital and Cancer Center-Collierville
  - Cookeville, Tennessee, United States, 38501
    - Cookeville Regional Medical Center
  - Franklin, Tennessee, United States, 37067
    - Vanderbilt-Ingram Cancer Center Cool Springs
  - Franklin, Tennessee, United States, 37067
    - Vanderbilt-Ingram Cancer Center at Franklin
  - Germantown, Tennessee, United States, 38138
    - The West Clinic - Wolf River
  - Hixson, Tennessee, United States, 37343
    - Pulmonary Medicine Center of Chattanooga-Hixson
  - Kingsport, Tennessee, United States, 37660
    - Wellmont Holston Valley Hospital and Medical Center
  - Kingsport, Tennessee, United States, 37660
    - Regional Cancer Center at Indian Path Community Hospital
  - Memphis, Tennessee, United States, 38120
    - Baptist Memorial Hospital and Cancer Center-Memphis
  - Memphis, Tennessee, United States, 38104
    - The West Clinic - Mid-Town
  - Nashville, Tennessee, United States, 37232
    - Vanderbilt University/Ingram Cancer Center
  - Nashville, Tennessee, United States, 37204
    - Vanderbilt Breast Center at One Hundred Oaks
  - Ooltewah, Tennessee, United States, 37363
    - Memorial GYN Plus
- Texas
  - Abilene, Texas, United States, 79601
    - Hendrick Medical Center
  - Bryan, Texas, United States, 77802
    - Saint Joseph Regional Cancer Center
  - Dallas, Texas, United States, 75235
    - Parkland Memorial Hospital
  - Dallas, Texas, United States, 75390
    - UT Southwestern/Simmons Cancer Center-Dallas
  - Fort Worth, Texas, United States, 76104
    - UT Southwestern/Simmons Cancer Center-Fort Worth
  - Houston, Texas, United States, 77030
    - M D Anderson Cancer Center
  - Houston, Texas, United States, 77030
    - Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
  - Houston, Texas, United States, 77030
    - Michael E DeBakey VA Medical Center
  - Houston, Texas, United States, 77030
    - Ben Taub General Hospital
  - Richardson, Texas, United States, 75080
    - UT Southwestern Clinical Center at Richardson/Plano
  - San Antonio, Texas, United States, 78229
    - University of Texas Health Science Center at San Antonio
- Utah
  - Farmington, Utah, United States, 84025
    - Farmington Health Center
  - Salt Lake City, Utah, United States, 84112
    - Huntsman Cancer Institute/University of Utah
  - Salt Lake City, Utah, United States, 84106
    - University of Utah Sugarhouse Health Center
- Vermont
  - Berlin, Vermont, United States, 05602
    - Central Vermont Medical Center/National Life Cancer Treatment
  - Burlington, Vermont, United States, 05401
    - University of Vermont Medical Center
  - Burlington, Vermont, United States, 05405
    - University of Vermont and State Agricultural College
- Virginia
  - Bristol, Virginia, United States, 24201
    - Wellmont Medical Associates-Bristol
  - Norton, Virginia, United States, 24273
    - Southwest VA Regional Cancer Center
  - Richmond, Virginia, United States, 23235
    - VCU Massey Cancer Center at Stony Point
  - Richmond, Virginia, United States, 23298
    - Virginia Commonwealth University/Massey Cancer Center
- Washington
  - Aberdeen, Washington, United States, 98520
    - Providence Regional Cancer System-Aberdeen
  - Bellevue, Washington, United States, 98004
    - Overlake Medical Center
  - Bellingham, Washington, United States, 98225
    - PeaceHealth Saint Joseph Medical Center
  - Bremerton, Washington, United States, 98310
    - Harrison HealthPartners Hematology and Oncology-Bremerton
  - Bremerton, Washington, United States, 98310
    - Harrison Medical Center
  - Burien, Washington, United States, 98166
    - Highline Medical Center-Main Campus
  - Centralia, Washington, United States, 98531
    - Providence Regional Cancer System-Centralia
  - Edmonds, Washington, United States, 98026
    - Swedish Cancer Institute-Edmonds
  - Enumclaw, Washington, United States, 98022
    - Saint Elizabeth Hospital
  - Everett, Washington, United States, 98201
    - Providence Regional Cancer Partnership
  - Federal Way, Washington, United States, 98003
    - Saint Francis Hospital
  - Issaquah, Washington, United States, 98029
    - Swedish Cancer Institute-Issaquah
  - Kennewick, Washington, United States, 99336
    - Kadlec Clinic Hematology and Oncology
  - Lacey, Washington, United States, 98503
    - Providence Regional Cancer System-Lacey
  - Lakewood, Washington, United States, 98499
    - Saint Clare Hospital
  - Longview, Washington, United States, 98632
    - PeaceHealth Saint John Medical Center
  - Poulsbo, Washington, United States, 98370
    - Harrison HealthPartners Hematology and Oncology-Poulsbo
  - Renton, Washington, United States, 98055
    - Valley Medical Center
  - Seattle, Washington, United States, 98107
    - Swedish Medical Center-Ballard Campus
  - Seattle, Washington, United States, 98112
    - Kaiser Permanente Washington
  - Seattle, Washington, United States, 98104
    - Pacific Gynecology Specialists
  - Seattle, Washington, United States, 98122-4307
    - Swedish Medical Center-First Hill
  - Seattle, Washington, United States, 98122-5711
    - Swedish Medical Center-Cherry Hill
  - Sedro-Woolley, Washington, United States, 98284
    - PeaceHealth United General Medical Center
  - Shelton, Washington, United States, 98584
    - Providence Regional Cancer System-Shelton
  - Tacoma, Washington, United States, 98405
    - Northwest Medical Specialties PLLC
  - Tacoma, Washington, United States, 98405
    - Franciscan Research Center-Northwest Medical Plaza
  - Vancouver, Washington, United States, 98686
    - Legacy Salmon Creek Hospital
  - Vancouver, Washington, United States, 98664
    - PeaceHealth Southwest Medical Center
  - Vancouver, Washington, United States, 98684
    - Legacy Cancer Institute Medical Oncology and Day Treatment
  - Walla Walla, Washington, United States, 99362
    - Providence Saint Mary Regional Cancer Center
  - Yelm, Washington, United States, 98597
    - Providence Regional Cancer System-Yelm
- West Virginia
  - Bridgeport, West Virginia, United States, 26330
    - United Hospital Center
  - Martinsburg, West Virginia, United States, 25401
    - WVUH-Berkely Medical Center
  - Morgantown, West Virginia, United States, 26506
    - West Virginia University Healthcare
  - Parkersburg, West Virginia, United States, 26101
    - Camden Clark Medical Center
- Wisconsin
  - Ashland, Wisconsin, United States, 54806
    - Duluth Clinic Ashland
  - Ashland, Wisconsin, United States, 54806
    - Northwest Wisconsin Cancer Center
  - Burlington, Wisconsin, United States, 53105
    - Aurora Cancer Care-Southern Lakes VLCC
  - Chippewa Falls, Wisconsin, United States, 54729
    - Marshfield Clinic-Chippewa Center
  - Eau Claire, Wisconsin, United States, 54701
    - Marshfield Medical Center-EC Cancer Center
  - Eau Claire, Wisconsin, United States, 54701
    - Mayo Clinic Health System-Eau Claire Clinic
  - Fond Du Lac, Wisconsin, United States, 54937
    - Aurora Health Center-Fond du Lac
  - Germantown, Wisconsin, United States, 53022
    - Aurora Health Care Germantown Health Center
  - Grafton, Wisconsin, United States, 53024
    - Aurora Cancer Care-Grafton
  - Green Bay, Wisconsin, United States, 54311
    - Aurora BayCare Medical Center
  - Green Bay, Wisconsin, United States, 54301
    - Saint Vincent Hospital Cancer Center Green Bay
  - Green Bay, Wisconsin, United States, 54303
    - Saint Vincent Hospital Cancer Center at Saint Mary's
  - Green Bay, Wisconsin, United States, 54301
    - Bellin Memorial Hospital
  - Kenosha, Wisconsin, United States, 53142
    - Aurora Cancer Care-Kenosha South
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran Medical Center
  - La Crosse, Wisconsin, United States, 54601
    - Mayo Clinic Health System-Franciscan Healthcare
  - Ladysmith, Wisconsin, United States, 54848
    - Marshfield Clinic - Ladysmith Center
  - Madison, Wisconsin, United States, 53792
    - University of Wisconsin Hospital and Clinics
  - Marinette, Wisconsin, United States, 54143
    - Aurora Bay Area Medical Group-Marinette
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Medical Center-Marshfield
  - Milwaukee, Wisconsin, United States, 53209
    - Aurora Cancer Care-Milwaukee
  - Milwaukee, Wisconsin, United States, 53215
    - Aurora Saint Luke's Medical Center
  - Milwaukee, Wisconsin, United States, 53233
    - Aurora Sinai Medical Center
  - Minocqua, Wisconsin, United States, 54548
    - Marshfield Clinic-Minocqua Center
  - Mukwonago, Wisconsin, United States, 53149
    - ProHealth D N Greenwald Center
  - New Richmond, Wisconsin, United States, 54017
    - Cancer Center of Western Wisconsin
  - Oconomowoc, Wisconsin, United States, 53066
    - ProHealth Oconomowoc Memorial Hospital
  - Oconto Falls, Wisconsin, United States, 54154
    - Saint Vincent Hospital Cancer Center at Oconto Falls
  - Oshkosh, Wisconsin, United States, 54904
    - Vince Lombardi Cancer Clinic - Oshkosh
  - Racine, Wisconsin, United States, 53406
    - Aurora Cancer Care-Racine
  - Rice Lake, Wisconsin, United States, 54868
    - Marshfield Medical Center-Rice Lake
  - Sheboygan, Wisconsin, United States, 53081
    - Vince Lombardi Cancer Clinic-Sheboygan
  - Stevens Point, Wisconsin, United States, 54482
    - Marshfield Clinic Stevens Point Center
  - Sturgeon Bay, Wisconsin, United States, 54235-1495
    - Saint Vincent Hospital Cancer Center at Sturgeon Bay
  - Summit, Wisconsin, United States, 53066
    - Aurora Medical Center in Summit
  - Two Rivers, Wisconsin, United States, 54241
    - Vince Lombardi Cancer Clinic-Two Rivers
  - Waukesha, Wisconsin, United States, 53188
    - UW Cancer Center at ProHealth Care
  - Waukesha, Wisconsin, United States, 53188
    - ProHealth Waukesha Memorial Hospital
  - Wausau, Wisconsin, United States, 54401
    - Marshfield Clinic-Wausau Center
  - Wauwatosa, Wisconsin, United States, 53226
    - Aurora Cancer Care-Milwaukee West
  - West Allis, Wisconsin, United States, 53227
    - Aurora West Allis Medical Center
  - Weston, Wisconsin, United States, 54476
    - Marshfield Clinic - Weston Center
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Marshfield Clinic - Wisconsin Rapids Center
- Wyoming
  - Cody, Wyoming, United States, 82414
    - Billings Clinic-Cody
  - Sheridan, Wyoming, United States, 82801
    - Welch Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Patients must have histologically or cytologically confirmed intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer
- NOTE: Pathology report must be uploaded in Rave. Histology report must be consistent with an adenocarcinoma with pancreaticobiliary primary assuming there are no pancreatic lesions and other primaries are ruled out per local standard
Patients must have documented metastatic or locally advanced unresectable disease on computed tomography (CT) or magnetic resonance (MR) imaging CT scans or MRIs used to assess measurable disease. Must have been completed within 28 days prior to registration. CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form
Patient must not have a current diagnosis of ampullary cancer
Patients must not have received prior systemic therapy for the current metastatic or locally advanced biliary cancer
Patient must not have received adjuvant therapy within 6 months prior to registration
Patients must have a complete medical history and physical exam within 28 days prior to registration
Patients must have a Zubrod performance status of 0 or 1
Patients must not have a history of peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse Events (CTCAE) 5.0. In CTCAE version 5.0 grade 2 sensory neuropathy is defined as ?moderate symptoms; limiting instrumental activities of daily living (ADLs)?
Absolute neutrophil count (ANC) >= 1,500/mcL (obtained within 28 days prior to registration)
Platelets >= 100,000/mcL (obtained within 28 days prior to registration)
Hemoglobin >= 8 g/dL (obtained within 28 days prior to registration)
Serum albumin >= 2.8 g/dL (obtained within 28 days prior to registration)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except patients with Gilbert?s syndrome, who must have a direct bilirubin < 1.5 mg/dL) (obtained within 28 days prior to registration)
Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 8 x IULN (obtained within 28 days prior to registration)
Serum creatinine =< IULN OR calculated creatinine clearance >= 60 mL/min (obtained within 28 days prior to registration)
Patients must have CA19-9 obtained within 42 days prior to registration
Patients must have sodium, potassium, bicarbonate, chloride, blood urea nitrogen (BUN), calcium, total protein, magnesium, and alkaline phosphatase obtained within 28 days prior to registration
Patients must not have an active infection requiring systemic therapy
No other prior malignancy is allowed except for the following: adequately treated basal cell 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 two years
Patients must not be pregnant or nursing. Women/men of reproductive potential must have agreed to use an effective contraceptive method. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
Sites must seek additional patient consent for the future use of specimens
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (nab-paclitaxel, cisplatin, gemcitabine hydrochloride) Patients receive nab-paclitaxel IV over 30 minutes, cisplatin IV over 60 minutes, and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Drug: Cisplatin Given IV Other Names: CDDP Cis-diamminedichloridoplatinum Cismaplat Cisplatinum Neoplatin Platinol Abiplatin Blastolem Briplatin Cis-diammine-dichloroplatinum Cis-diamminedichloro Platinum (II) Cis-diamminedichloroplatinum Cis-dichloroammine Platinum (II) Cis-platinous Diamine Dichloride Cis-platinum Cis-platinum II Cis-platinum II Diamine Dichloride Cisplatina Cisplatyl Citoplatino Citosin Cysplatyna DDP Lederplatin Metaplatin Peyrone's Chloride Peyrone's Salt Placis Plastistil Platamine Platiblastin Platiblastin-S Platinex Platinol- AQ Platinol-AQ Platinol-AQ VHA Plus Platinoxan Platinum Platinum Diamminodichloride Platiran Platistin Platosin Drug: Nab-paclitaxel Given IV Other Names: ABI-007 Abraxane Albumin-bound Paclitaxel ABI 007 Albumin-Stabilized Nanoparticle Paclitaxel Nanoparticle Albumin-bound Paclitaxel Nanoparticle Paclitaxel paclitaxel albumin-stabilized nanoparticle formulation Protein-bound Paclitaxel Drug: Gemcitabine Hydrochloride Given IV Other Names: Gemzar dFdCyd Difluorodeoxycytidine Hydrochloride LY-188011 LY188011
Experimental: Arm II (cisplatin, gemcitabine hydrochloride) Patients receive cisplatin IV over 60 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Drug: Cisplatin Given IV Other Names: CDDP Cis-diamminedichloridoplatinum Cismaplat Cisplatinum Neoplatin Platinol Abiplatin Blastolem Briplatin Cis-diammine-dichloroplatinum Cis-diamminedichloro Platinum (II) Cis-diamminedichloroplatinum Cis-dichloroammine Platinum (II) Cis-platinous Diamine Dichloride Cis-platinum Cis-platinum II Cis-platinum II Diamine Dichloride Cisplatina Cisplatyl Citoplatino Citosin Cysplatyna DDP Lederplatin Metaplatin Peyrone's Chloride Peyrone's Salt Placis Plastistil Platamine Platiblastin Platiblastin-S Platinex Platinol- AQ Platinol-AQ Platinol-AQ VHA Plus Platinoxan Platinum Platinum Diamminodichloride Platiran Platistin Platosin Drug: Gemcitabine Hydrochloride Given IV Other Names: Gemzar dFdCyd Difluorodeoxycytidine Hydrochloride LY-188011 LY188011

Participant Group / Arm

Intervention / Treatment

Experimental: Arm I (nab-paclitaxel, cisplatin, gemcitabine hydrochloride)

Patients receive nab-paclitaxel IV over 30 minutes, cisplatin IV over 60 minutes, and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: Cisplatin

Given IV

Other Names:

CDDP
Cis-diamminedichloridoplatinum
Cismaplat
Cisplatinum
Neoplatin
Platinol
Abiplatin
Blastolem
Briplatin
Cis-diammine-dichloroplatinum
Cis-diamminedichloro Platinum (II)
Cis-diamminedichloroplatinum
Cis-dichloroammine Platinum (II)
Cis-platinous Diamine Dichloride
Cis-platinum
Cis-platinum II
Cis-platinum II Diamine Dichloride
Cisplatina
Cisplatyl
Citoplatino
Citosin
Cysplatyna
DDP
Lederplatin
Metaplatin
Peyrone's Chloride
Peyrone's Salt
Placis
Plastistil
Platamine
Platiblastin
Platiblastin-S
Platinex
Platinol- AQ
Platinol-AQ
Platinol-AQ VHA Plus
Platinoxan
Platinum
Platinum Diamminodichloride
Platiran
Platistin
Platosin

Drug: Nab-paclitaxel

Given IV

Other Names:

ABI-007
Abraxane
Albumin-bound Paclitaxel
ABI 007
Albumin-Stabilized Nanoparticle Paclitaxel
Nanoparticle Albumin-bound Paclitaxel
Nanoparticle Paclitaxel
paclitaxel albumin-stabilized nanoparticle formulation
Protein-bound Paclitaxel

Drug: Gemcitabine Hydrochloride

Given IV

Other Names:

Gemzar
dFdCyd
Difluorodeoxycytidine Hydrochloride
LY-188011
LY188011

Experimental: Arm II (cisplatin, gemcitabine hydrochloride)

Patients receive cisplatin IV over 60 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: Cisplatin

Given IV

Other Names:

CDDP
Cis-diamminedichloridoplatinum
Cismaplat
Cisplatinum
Neoplatin
Platinol
Abiplatin
Blastolem
Briplatin
Cis-diammine-dichloroplatinum
Cis-diamminedichloro Platinum (II)
Cis-diamminedichloroplatinum
Cis-dichloroammine Platinum (II)
Cis-platinous Diamine Dichloride
Cis-platinum
Cis-platinum II
Cis-platinum II Diamine Dichloride
Cisplatina
Cisplatyl
Citoplatino
Citosin
Cysplatyna
DDP
Lederplatin
Metaplatin
Peyrone's Chloride
Peyrone's Salt
Placis
Plastistil
Platamine
Platiblastin
Platiblastin-S
Platinex
Platinol- AQ
Platinol-AQ
Platinol-AQ VHA Plus
Platinoxan
Platinum
Platinum Diamminodichloride
Platiran
Platistin
Platosin

Drug: Gemcitabine Hydrochloride

Given IV

Other Names:

Gemzar
dFdCyd
Difluorodeoxycytidine Hydrochloride
LY-188011
LY188011

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS) Time Frame: Up to 3 years	OS will be determined using the log-rank test with stratification by disease site (gallbladder adenocarcinoma versus [vs.] intrahepatic cholangiocarcinoma vs. extrahepatic cholangiocarcinoma), disease stage (locally advanced vs. metastatic), and Zubrod performance status (0 vs. 1). Distributions of overall survival by treatment arm will be estimated using the method of Kaplan-Meier.	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Time Frame: Up to 3 years	Rates of serious toxicities will be compared between arms.	Up to 3 years
Progression-free survival (PFS) Time Frame: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years	Distributions of PFS will be described using cumulative incidence estimates with differences in these estimates between treatment arms assessed by a stratified Cox regression model.	From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years
Overall response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria Time Frame: Up to 3 years	ORR is defined as confirmed and unconfirmed; complete response + partial response + stable disease. The chi-square test will be used to compare ORR, disease control rate (DCR), and rates of toxicity events across arms. ORR will be assessed in the subset of patients with measurable disease.	Up to 3 years
Disease control rate as measured by RECIST 1.1 criteria Time Frame: Up to 3 years	The chi-square test will be used to compare ORR, DCR, and rates of toxicity events across arms. Disease control includes confirmed and unconfirmed complete response, confirmed and unconfirmed partial response, and stable disease. In patients with non-measurable disease, disease control will be defined as those who are alive without disease progression.	Up to 3 years
Changes in carbohydrate antigen 19-9 (CA 19-9) levels Time Frame: Baseline up to course 3	Correlations between changes in CA19-9 levels from baseline to post-treatment and ORR will be estimated via logistic regression models, both within each treatment arm and in the overall cohort. Analyses will explore the prognostic and predictive values of CA19-9 for disease response.	Baseline up to course 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SWOG Cancer Research Network

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Rachna Shroff, SWOG Cancer Research Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2019

Primary Completion (Actual)

October 4, 2023

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

December 6, 2018

First Submitted That Met QC Criteria

December 6, 2018

First Posted (Actual)

December 7, 2018

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

S1815 (Other Identifier: CTEP)
U10CA180888 (U.S. NIH Grant/Contract)
NCI-2018-01920 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Preoperative Nab-paclitaxel, Cisplatin, and Gemcitabine Chemotherapy With or Without Infigratinib Targeted Therapy for the Treatment of Resectable Intrahepatic Cholangiocarcinoma, The OPTIC Trial

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Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver

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University of Kansas Medical Center
National Cancer Institute (NCI)

Recruiting

Sacituzumab Govitecan for the Treatment for Patients With Locally Advanced, Recurrent, or Metastatic Cholangiocarcinoma

Stage III Intrahepatic Cholangiocarcinoma AJCC v8 | Metastatic Cholangiocarcinoma | Locally Advanced Cholangiocarcinoma | Stage III Hilar Cholangiocarcinoma AJCC v8 | Stage IV Hilar Cholangiocarcinoma AJCC v8 | Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 | Recurrent Cholangiocarcinoma

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Atezolizumab With or Without Cobimetinib in Treating Patients With Metastatic Bile Duct Cancer That Cannot Be Removed by Surgery or Gallbladder Cancer

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Mayo Clinic
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Malignant Solid Neoplasm | Cholangiocarcinoma | Stage III Intrahepatic Cholangiocarcinoma AJCC v8 | Gallbladder Carcinoma | Stage III Gallbladder Cancer AJCC v8 | Stage III Hilar Cholangiocarcinoma AJCC v8 | Stage IV Gallbladder Cancer AJCC v8 | Stage IV Hilar Cholangiocarcinoma AJCC v8 | Stage IV Intrahepatic...

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Inhalation SLIT Cisplatin (Liposomal) for the Treatment of Osteosarcoma Metastatic to the Lung

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Safety and Efficacy Study of PRV111 in Subjects With Oral Squamous Cell Carcinoma (PRV111)

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Samsung Medical Center

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A Randomized Phase II Study of Concurrent Chemoradiation With Every 3 Week of Cisplatin vs With Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma

Nasophayngeal Carcinoma Between Stage II and IVb

Korea, Republic of
Cedars-Sinai Medical Center

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Trial of De-Intensified Post-operative Chemoradiation Following Robotic Surgery for HPV-positive Oropharyngeal Cancer

HPV Positive Oropharyngeal Squamous Cell Carcinoma

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Weekly Versus Three-week Chemoradiation in Patients With Advanced Cervical Cancer

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A Safety and Efficacy Study in Patients With Gastric Cancer

Gastric Cancer

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Low-Dose Weekly vs High-Dose Cisplatin (RADIO)

Locally Advanced Head and Neck Squamous Cell Carcinoma

Canada
Sun Yat-sen University

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Phase II Trial of Neoadjuvant and Adjuvant Anti-PD-1 Antibody Toripalimab Combined With CCRT in NPC Patients

Nasopharyngeal Carcinoma

China
Sun Yat-sen University
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GP vs PF as Induction Chemotherapy Combined With CCRT for Locoregionally Advanced Nasopharyngeal Carcinoma

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Gemcitabine Hydrochloride and Cisplatin With or Without Nab-Paclitaxel in Treating Patients With Newly Diagnosed Advanced Biliary Tract Cancers

A Phase III Randomized Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel Versus Gemcitabine and Cisplatin in Newly Diagnosed, Advanced Biliary Tract Cancers

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Study record dates

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Study Start (Actual)

Primary Completion (Actual)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Estimated)

Last Update Submitted That Met QC Criteria

Last Verified

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Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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Drug Interventions

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