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

April 3, 2024 updated by: National Cancer Institute (NCI)

A Phase 2 Study of Pevonedistat in Combination With Carboplatin and Paclitaxel in Advanced Intrahepatic Cholangiocarcinoma

This phase II trial studies how well pevonedistat alone or in combination with chemotherapy (paclitaxel and carboplatin) works in treating patients with bile duct cancer of the liver. Pevonedistat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as paclitaxel and carboplatin, 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. This study may help the study doctors find out how well pevonedistat shrinks bile duct cancer of the liver when given alone and when in combination with paclitaxel and carboplatin.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To determine the objective response rate of pevonedistat as a single agent and in combination with carboplatin and paclitaxel in patients with unresectable intrahepatic cholangiocarcinoma.

SECONDARY OBJECTIVES:

I. To evaluate the safety profile of pevonedistat alone and in combination with carboplatin and paclitaxel in patients with intrahepatic cholangiocarcinoma.

II. To determine the clinical benefit rate of patients with advanced intrahepatic cholangiocarcinoma (ICC) treated with pevonedistat monotherapy and in combination with carboplatin and paclitaxel.

III. To determine progression-free survival of patients treated with pevonedistat monotherapy and in combination with carboplatin and paclitaxel.

IV. To determine overall survival of patients treated with pevonedistat monotherapy and in combination with carboplatin and paclitaxel.

EXPLORATORY OBJECTIVES:

I. To determine whether overexpression of NEDD8, NAE1, and UBC12 predict response to treatment.

II. To identify the mutation profile of those cholangiocarcinomas with overexpression of the neddylation pathway.

III. To bank specimens for further future investigations.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive pevonedistat intravenously (IV) over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive pevonedistat IV over 1 hour on days 1, 3, and 5, paclitaxel IV over 3 hours on day 1, and carboplatin IV over 15-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Starting cycle 5, patients may receive pevonedistat monotherapy at the discretion of treating physician.

After completion of study treatment, patients are followed up at 30 days after last dose of study treatment, then every 3 months for the first year and every 6 months for years 2-3.

Study Type

Interventional

Enrollment (Estimated)

Phase

Phase 2

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
  - Kingman, Arizona, United States, 86401
    - Kingman Regional Medical Center
  - Phoenix, Arizona, United States, 85004
    - Cancer Center at Saint Joseph's
- Arkansas
  - Hot Springs, Arkansas, United States, 71913
    - CHI Saint Vincent Cancer Center Hot Springs
- California
  - Arroyo Grande, California, United States, 93420
    - PCR Oncology
  - Arroyo Grande, California, United States, 93420
    - Mission Hope Medical Oncology - Arroyo Grande
  - Auburn, California, United States, 95602
    - Sutter Auburn Faith Hospital
  - Auburn, California, United States, 95603
    - Sutter Cancer Centers Radiation Oncology Services-Auburn
  - Berkeley, California, United States, 94704
    - Alta Bates Summit Medical Center-Herrick Campus
  - Burbank, California, United States, 91505
    - Providence Saint Joseph Medical Center/Disney Family Cancer Center
  - Cameron Park, California, United States, 95682
    - Sutter Cancer Centers Radiation Oncology Services-Cameron Park
  - Castro Valley, California, United States, 94546
    - Eden Hospital Medical Center
  - Davis, California, United States, 95616
    - Sutter Davis Hospital
  - Duarte, California, United States, 91010
    - City of Hope Comprehensive Cancer Center
  - Fremont, California, United States, 94538
    - Palo Alto Medical Foundation-Fremont
  - Modesto, California, United States, 95355
    - Memorial Medical Center
  - Mountain View, California, United States, 94040
    - Palo Alto Medical Foundation-Camino Division
  - Mountain View, California, United States, 94040
    - Palo Alto Medical Foundation-Gynecologic Oncology
  - Palo Alto, California, United States, 94301
    - Palo Alto Medical Foundation Health Care
  - Roseville, California, United States, 95661
    - Sutter Cancer Centers Radiation Oncology Services-Roseville
  - Roseville, California, United States, 95661
    - Sutter Roseville Medical Center
  - Sacramento, California, United States, 95816
    - Sutter Medical Center Sacramento
  - San Francisco, California, United States, 94115
    - California Pacific Medical Center-Pacific Campus
  - San Mateo, California, United States, 94401
    - Mills Health Center
  - Santa Cruz, California, United States, 95065
    - Palo Alto Medical Foundation-Santa Cruz
  - Santa Maria, California, United States, 93444
    - Mission Hope Medical Oncology - Santa Maria
  - Santa Rosa, California, United States, 95403
    - Sutter Pacific Medical Foundation
  - Sunnyvale, California, United States, 94086
    - Palo Alto Medical Foundation-Sunnyvale
  - Vacaville, California, United States, 95687
    - Sutter Cancer Centers Radiation Oncology Services-Vacaville
  - Vallejo, California, United States, 94589
    - Sutter Solano Medical Center/Cancer Center
- Colorado
  - Colorado Springs, Colorado, United States, 80907
    - Penrose-Saint Francis Healthcare
  - Colorado Springs, Colorado, United States, 80909
    - UCHealth Memorial Hospital Central
  - Colorado Springs, Colorado, United States, 80907
    - Rocky Mountain Cancer Centers-Penrose
  - Colorado Springs, Colorado, United States, 80920
    - Memorial Hospital North
  - Denver, Colorado, United States, 80210
    - Porter Adventist Hospital
  - Durango, Colorado, United States, 81301
    - Mercy Medical Center
  - Durango, Colorado, United States, 81301
    - Southwest Oncology PC
  - Fort Collins, Colorado, United States, 80524
    - Poudre Valley Hospital
  - Fort Collins, Colorado, United States, 80528
    - Cancer Care and Hematology-Fort Collins
  - Greeley, Colorado, United States, 80631
    - UCHealth Greeley Hospital
  - Lakewood, Colorado, United States, 80228
    - Saint Anthony Hospital
  - 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
  - Loveland, Colorado, United States, 80538
    - Medical Center of the Rockies
  - Parker, Colorado, United States, 80138
    - Parker Adventist Hospital
  - Pueblo, Colorado, United States, 81004
    - Saint Mary Corwin Medical Center
- Florida
  - Coral Gables, Florida, United States, 33146
    - UM Sylvester Comprehensive Cancer Center at Coral Gables
  - Deerfield Beach, Florida, United States, 33442
    - UM Sylvester Comprehensive Cancer Center at Deerfield Beach
  - Fort Lauderdale, Florida, United States, 33308
    - Holy Cross Hospital
  - Miami, Florida, United States, 33136
    - University of Miami Miller School of Medicine-Sylvester Cancer Center
  - Miami, Florida, United States, 33176
    - UM Sylvester Comprehensive Cancer Center at Kendall
  - Plantation, Florida, United States, 33324
    - UM Sylvester Comprehensive Cancer Center at Plantation
- Hawaii
  - '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
  - 'Aiea, Hawaii, United States, 96701
    - Hawaii Cancer Care - Westridge
  - 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
    - Hawaii Cancer Care Inc - Waterfront Plaza
  - 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
  - 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 Cancer Institute - Boise
  - Caldwell, Idaho, United States, 83605
    - Saint Alphonsus Cancer Care Center-Caldwell
  - Coeur d'Alene, Idaho, United States, 83814
    - Kootenai Health - Coeur d'Alene
  - 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 Luke's Cancer Institute - Nampa
  - Nampa, Idaho, United States, 83687
    - Saint Alphonsus Cancer Care Center-Nampa
  - Post Falls, Idaho, United States, 83854
    - Kootenai Clinic Cancer Services - Post Falls
  - Sandpoint, Idaho, United States, 83864
    - Kootenai Cancer Clinic
  - Twin Falls, Idaho, United States, 83301
    - Saint Luke's Cancer Institute - Twin Falls
- Illinois
  - Chicago, Illinois, United States, 60611
    - Northwestern University
  - Lake Forest, Illinois, United States, 60045
    - Northwestern Medicine Lake Forest Hospital
- Indiana
  - Indianapolis, Indiana, United States, 46237
    - Franciscan Health Indianapolis
  - Indianapolis, Indiana, United States, 46202
    - Indiana University/Melvin and Bren Simon Cancer 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
    - Mary Greeley Medical Center
  - Ames, Iowa, United States, 50010
    - McFarland Clinic - Ames
  - Boone, Iowa, United States, 50036
    - McFarland Clinic - 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
  - 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, 50314
    - Mission Cancer and Blood - Laurel
  - Des Moines, Iowa, United States, 50316
    - Iowa Lutheran Hospital
  - Fort Dodge, Iowa, United States, 50501
    - Trinity Regional Medical Center
  - Fort Dodge, Iowa, United States, 50501
    - McFarland Clinic - Trinity Cancer Center
  - Jefferson, Iowa, United States, 50129
    - McFarland Clinic - Jefferson
  - Marshalltown, Iowa, United States, 50158
    - McFarland Clinic - Marshalltown
  - West Des Moines, Iowa, United States, 50266-7700
    - Methodist West Hospital
  - West Des Moines, Iowa, United States, 50266
    - Mercy Medical Center-West Lakes
- Kansas
  - Fairway, Kansas, United States, 66205
    - University of Kansas Clinical Research Center
  - Hays, Kansas, United States, 67601
    - HaysMed University of Kansas Health System
  - Kansas City, Kansas, United States, 66160
    - University of Kansas Cancer Center
  - Kansas City, Kansas, United States, 66112
    - University of Kansas Cancer Center-West
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
  - Olathe, Kansas, United States, 66061
    - Olathe Health Cancer Center
  - Overland Park, Kansas, United States, 66210
    - University of Kansas Cancer Center-Overland Park
  - Pittsburg, Kansas, United States, 66762
    - Ascension Via Christi - Pittsburg
  - Salina, Kansas, United States, 67401
    - Salina Regional Health Center
  - Topeka, Kansas, United States, 66606
    - University of Kansas Health System Saint Francis Campus
  - Westwood, Kansas, United States, 66205
    - University of Kansas Hospital-Westwood Cancer Center
- 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
    - Jewish Hospital
  - Louisville, Kentucky, United States, 40245
    - UofL Health Medical Center Northeast
  - Louisville, Kentucky, United States, 40215
    - Saints Mary and Elizabeth Hospital
  - Shepherdsville, Kentucky, United States, 40165
    - Jewish Hospital Medical Center South
- Maine
  - Brewer, Maine, United States, 04412
    - Lafayette Family Cancer Center-EMMC
- Massachusetts
  - Springfield, Massachusetts, United States, 01104
    - Mercy Medical Center
  - Worcester, Massachusetts, United States, 01655
    - UMass Memorial Medical Center - University Campus
- Michigan
  - Ann Arbor, Michigan, United States, 48106
    - Saint Joseph Mercy Hospital
  - Battle Creek, Michigan, United States, 49017
    - Bronson Battle Creek
  - Bay City, Michigan, United States, 48706
    - McLaren Cancer Institute-Bay City
  - Brighton, Michigan, United States, 48114
    - Saint Joseph Mercy Brighton
  - Brighton, Michigan, United States, 48114
    - Trinity Health IHA Medical Group Hematology Oncology - Brighton
  - Canton, Michigan, United States, 48188
    - Saint Joseph Mercy Canton
  - Canton, Michigan, United States, 48188
    - Trinity Health IHA Medical Group Hematology Oncology - Canton
  - Caro, Michigan, United States, 48723
    - Caro Cancer Center
  - Chelsea, Michigan, United States, 48118
    - Saint Joseph Mercy Chelsea
  - Chelsea, Michigan, United States, 48118
    - Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
  - Clarkston, Michigan, United States, 48346
    - McLaren Cancer Institute-Clarkston
  - Clarkston, Michigan, United States, 48346
    - Hematology Oncology Consultants-Clarkston
  - Clarkston, Michigan, United States, 48346
    - Newland Medical Associates-Clarkston
  - Detroit, Michigan, United States, 48201
    - Wayne State University/Karmanos Cancer Institute
  - Detroit, Michigan, United States, 48236
    - Ascension Saint John Hospital
  - East China Township, Michigan, United States, 48054
    - Great Lakes Cancer Management Specialists-Doctors Park
  - 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
  - Flint, Michigan, United States, 48503
    - Hurley Medical Center
  - Flint, Michigan, United States, 48503
    - Genesee Cancer and Blood Disease Treatment Center
  - Flint, Michigan, United States, 48503
    - Genesee Hematology Oncology PC
  - Flint, Michigan, United States, 48503
    - Genesys Hurley Cancer Institute
  - 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
    - Trinity Health Grand Rapids Hospital
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Academic Hematology Oncology Specialists
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Michigan Breast Specialists-Grosse Pointe Woods
  - 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, 48912
    - Mid-Michigan Physicians-Lansing
  - Lansing, Michigan, United States, 48910
    - Karmanos Cancer Institute at McLaren Greater Lansing
  - Lansing, Michigan, United States, 48912
    - University of Michigan Health - Sparrow Lansing
  - Lapeer, Michigan, United States, 48446
    - McLaren Cancer Institute-Lapeer Region
  - Livonia, Michigan, United States, 48154
    - Trinity Health Saint Mary Mercy Livonia Hospital
  - Livonia, Michigan, United States, 48154
    - Hope Cancer Clinic
  - Macomb, Michigan, United States, 48044
    - Great Lakes Cancer Management Specialists-Macomb Medical Campus
  - Macomb, Michigan, United States, 48044
    - Michigan Breast Specialists-Macomb Township
  - Marlette, Michigan, United States, 48453
    - Saint Mary's Oncology/Hematology Associates of Marlette
  - 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
    - Trinity Health Muskegon Hospital
  - Niles, Michigan, United States, 49120
    - Corewell Health Lakeland Hospitals - Niles Hospital
  - Norton Shores, Michigan, United States, 49444
    - Cancer and Hematology Centers of Western Michigan - Norton Shores
  - Petoskey, Michigan, United States, 49770
    - McLaren Cancer Institute-Northern Michigan
  - Pontiac, Michigan, United States, 48341
    - Saint Joseph Mercy Oakland
  - Pontiac, Michigan, United States, 48341
    - 21st Century Oncology-Pontiac
  - Pontiac, Michigan, United States, 48341
    - Hope Cancer Center
  - Pontiac, Michigan, United States, 48341
    - Newland Medical Associates-Pontiac
  - Port Huron, Michigan, United States, 48060
    - McLaren-Port Huron
  - Reed City, Michigan, United States, 49677
    - Corewell Health Reed City Hospital
  - Rochester Hills, Michigan, United States, 48309
    - Great Lakes Cancer Management Specialists-Rochester Hills
  - Saginaw, Michigan, United States, 48601
    - Ascension Saint Mary's Hospital
  - Saginaw, Michigan, United States, 48604
    - Oncology Hematology Associates of Saginaw Valley PC
  - Saint Joseph, Michigan, United States, 49085
    - Lakeland Medical Center Saint Joseph
  - Saint Joseph, Michigan, United States, 49085
    - Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
  - Sterling Heights, Michigan, United States, 48312
    - Bhadresh Nayak MD PC-Sterling Heights
  - Tawas City, Michigan, United States, 48764
    - Ascension Saint Joseph Hospital
  - Traverse City, Michigan, United States, 49684
    - Munson Medical Center
  - Warren, Michigan, United States, 48093
    - Saint John Macomb-Oakland Hospital
  - Warren, Michigan, United States, 48088
    - Advanced Breast Care Center PLLC
  - Warren, Michigan, United States, 48093
    - Great Lakes Cancer Management Specialists-Macomb Professional Building
  - Warren, Michigan, United States, 48093
    - Macomb Hematology Oncology PC
  - Warren, Michigan, United States, 48093
    - Michigan Breast Specialists-Warren
  - West Branch, Michigan, United States, 48661
    - Saint Mary's Oncology/Hematology Associates of West Branch
  - Wyoming, Michigan, United States, 49519
    - University of Michigan Health - West
  - Ypsilanti, Michigan, United States, 48197
    - Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
  - Ypsilanti, Michigan, United States, 48106
    - Huron Gastroenterology PC
- Minnesota
  - 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
  - Edina, Minnesota, United States, 55435
    - Fairview Southdale Hospital
  - Fridley, Minnesota, United States, 55432
    - Unity Hospital
  - 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
  - Princeton, Minnesota, United States, 55371
    - Fairview Northland Medical Center
  - Robbinsdale, Minnesota, United States, 55422
    - North Memorial Medical Health Center
  - 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
  - Shakopee, Minnesota, United States, 55379
    - Saint Francis Regional Medical Center
  - Stillwater, Minnesota, United States, 55082
    - Lakeview Hospital
  - 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
  - Wyoming, Minnesota, United States, 55092
    - Fairview Lakes Medical Center
- Missouri
  - Kansas City, Missouri, United States, 64154
    - University of Kansas Cancer Center - North
  - Kansas City, Missouri, United States, 64108
    - Truman Medical Centers
  - Lee's Summit, Missouri, United States, 64064
    - University of Kansas Cancer Center - Lee's Summit
  - North Kansas City, Missouri, United States, 64116
    - University of Kansas Cancer Center at North Kansas City Hospital
- 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
  - 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
  - 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
  - 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
    - GenesisCare USA - 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, 89102
    - OptumCare Cancer Care at Charleston
  - Las Vegas, Nevada, United States, 89106
    - Radiation Oncology Centers of Nevada Central
  - Las Vegas, Nevada, United States, 89109
    - GenesisCare USA - Las Vegas
  - 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
    - GenesisCare USA - Vegas 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, 89148
    - GenesisCare USA - Fort Apache
  - Las Vegas, Nevada, United States, 89149
    - HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
  - 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, 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, 89169
    - University Cancer Center
  - Las Vegas, Nevada, United States, 89113
    - Urology Specialists of Nevada - Southwest
  - 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/Dartmouth Cancer Center
- New Jersey
  - Teaneck, New Jersey, United States, 07666
    - Holy Name Hospital
- New York
  - Buffalo, New York, United States, 14263
    - Roswell Park Cancer Institute
  - Rochester, New York, United States, 14642
    - University of Rochester
- North Carolina
  - Chapel Hill, North Carolina, United States, 27599
    - UNC Lineberger Comprehensive Cancer Center
  - Greenville, North Carolina, United States, 27834
    - East Carolina University
  - Hillsborough, North Carolina, United States, 27278
    - University of North Carolina-Hillsborough Campus
- Ohio
  - Beavercreek, Ohio, United States, 45431
    - Indu and Raj Soin Medical Center
  - Boardman, Ohio, United States, 44512
    - Saint Elizabeth Boardman Hospital
  - Centerville, Ohio, United States, 45459
    - Miami Valley Hospital South
  - Centerville, Ohio, United States, 45459
    - Dayton Physicians LLC-Miami Valley South
  - 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, 45247
    - TriHealth Cancer Institute-Westside
  - Cincinnati, Ohio, United States, 45255
    - TriHealth Cancer Institute-Anderson
  - Cleveland, Ohio, United States, 44109
    - MetroHealth Medical Center
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Foundation
  - Cleveland, Ohio, United States, 44111
    - Cleveland Clinic Cancer Center/Fairview Hospital
  - 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
  - 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
  - Greenville, Ohio, United States, 45331
    - Wayne Hospital
  - Greenville, Ohio, United States, 45331
    - Dayton Physicians LLC-Wayne
  - 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
  - Mansfield, Ohio, United States, 44906
    - Cleveland Clinic Cancer Center Mansfield
  - Mayfield Heights, Ohio, United States, 44124
    - Hillcrest Hospital Cancer Center
  - Sandusky, Ohio, United States, 44870
    - North Coast Cancer Care
  - Strongsville, Ohio, United States, 44136
    - Cleveland Clinic Cancer Center Strongsville
  - Troy, Ohio, United States, 45373
    - Upper Valley Medical Center
  - Troy, Ohio, United States, 45373
    - Dayton Physicians LLC - Troy
  - Warren, Ohio, United States, 44484
    - Saint Joseph Warren Hospital
  - Warrensville Heights, Ohio, United States, 44122
    - South Pointe Hospital
  - Wooster, Ohio, United States, 44691
    - Cleveland Clinic Wooster Family Health and Surgery Center
  - Youngstown, Ohio, United States, 44501
    - Saint Elizabeth Youngstown Hospital
- Oklahoma
  - Lawton, Oklahoma, United States, 73505
    - Cancer Centers of Southwest Oklahoma Research
  - Oklahoma City, Oklahoma, United States, 73104
    - University of Oklahoma Health Sciences Center
- 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
  - Newberg, Oregon, United States, 97132
    - Providence Newberg Medical Center
  - Ontario, Oregon, United States, 97914
    - Saint Alphonsus Medical Center-Ontario
  - 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
- Pennsylvania
  - Allentown, Pennsylvania, United States, 18103
    - Lehigh Valley Hospital-Cedar Crest
  - Bethlehem, Pennsylvania, United States, 18017
    - Lehigh Valley Hospital - Muhlenberg
  - East Stroudsburg, Pennsylvania, United States, 18301
    - Pocono Medical Center
  - Hazleton, Pennsylvania, United States, 18201
    - Lehigh Valley Hospital-Hazleton
  - Philadelphia, Pennsylvania, United States, 19111
    - Fox Chase Cancer Center
  - Philadelphia, Pennsylvania, United States, 19104
    - University of Pennsylvania/Abramson Cancer Center
  - Philadelphia, Pennsylvania, United States, 19140
    - Temple University Hospital
  - Pittsburgh, Pennsylvania, United States, 15232
    - University of Pittsburgh Cancer Institute (UPCI)
- South Carolina
  - Boiling Springs, South Carolina, United States, 29316
    - Prisma Health Cancer Institute - Spartanburg
  - Easley, South Carolina, United States, 29640
    - Prisma Health Cancer Institute - Easley
  - Greenville, South Carolina, United States, 29605
    - Prisma Health Cancer Institute - Faris
  - Greenville, South Carolina, United States, 29615
    - Prisma Health Cancer Institute - Eastside
  - Greenville, South Carolina, United States, 29605
    - Prisma Health Cancer Institute - Butternut
  - Greer, South Carolina, United States, 29650
    - Prisma Health Cancer Institute - Greer
  - Seneca, South Carolina, United States, 29672
    - Prisma Health Cancer Institute - Seneca
- South Dakota
  - Sioux Falls, South Dakota, United States, 57105
    - Avera Cancer Institute
- Tennessee
  - Bristol, Tennessee, United States, 37620
    - Bristol 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
  - Kingsport, Tennessee, United States, 37660
    - Ballad Health Cancer Care - Kingsport
  - Kingsport, Tennessee, United States, 37660
    - Wellmont Holston Valley Hospital and Medical Center
  - Nashville, Tennessee, United States, 37232
    - Vanderbilt University/Ingram Cancer Center
  - Nashville, Tennessee, United States, 37204
    - Vanderbilt Breast Center at One Hundred Oaks
- Texas
  - 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
  - Richardson, Texas, United States, 75080
    - UT Southwestern Clinical Center at Richardson/Plano
- Virginia
  - Bristol, Virginia, United States, 24201
    - Wellmont Medical Associates-Bristol
  - Martinsville, Virginia, United States, 24115
    - Sovah Health Martinsville
  - Norton, Virginia, United States, 24273
    - Southwest VA Regional 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, 98122
    - Swedish Medical Center-First Hill
  - Seattle, Washington, United States, 98104
    - Pacific Gynecology Specialists
  - 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, 98664
    - PeaceHealth Southwest Medical Center
  - Walla Walla, Washington, United States, 99362
    - Providence Saint Mary Regional Cancer Center
  - Yelm, Washington, United States, 98597
    - Providence Regional Cancer System-Yelm
- Wisconsin
  - Madison, Wisconsin, United States, 53792
    - University of Wisconsin Carbone Cancer Center
  - Menomonee Falls, Wisconsin, United States, 53051
    - Froedtert Menomonee Falls Hospital
  - Milwaukee, Wisconsin, United States, 53226
    - Medical College of Wisconsin
  - New Richmond, Wisconsin, United States, 54017
    - Cancer Center of Western Wisconsin
  - West Bend, Wisconsin, United States, 53095
    - Froedtert West Bend Hospital/Kraemer Cancer 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:

Patient must be >= 18 years of age
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Patient must have a life expectancy >= 12 weeks
Patient must have histologically confirmed intrahepatic cholangiocarcinoma or biphasic hepatocellular carcinoma and cholangiocarcinoma that is metastatic or unresectable and who have progressed on or been intolerant of one prior line of systemic gemcitabine containing chemotherapy regimen.
- NOTE: Prior immunotherapy or targeted therapies are allowed and will not be considered a line of therapy unless administered with cytotoxic chemotherapy
Patient must have measurable disease. For patients who have received localized therapy (embolization, chemoembolization, radiofrequency ablation or radiation) are eligible if measurable disease is not within the treatment field or the treated disease has clearly progressed since last localized therapy
Leukocytes >= 3,000/mcL (obtained within 14 days prior to randomization)
Absolute neutrophil count >= 1,500/mcL (obtained within 14 days prior to randomization)
Platelets >= 100,000/mcL (obtained within 14 days prior to randomization)
Total bilirubin =< institutional upper limit of normal (ULN) except in patients with Gilbert's syndrome. Patients with Gilbert's syndrome may enroll if direct bilirubin =< 1.5 x ULN of the direct bilirubin (obtained within 14 days prior to randomization)
Hemoglobin >= 9 g/dL (obtained within 14 days prior to randomization)
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained within 14 days prior to randomization)
Creatinine =< institutional ULN, OR glomerular filtration rate (GFR) >= 40 mL/min/1.73 m^2 (obtained within 14 days prior to randomization)
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Known HIV positive patients who meet the following criteria will be considered eligible:
- CD4 count >= 350 cells/mm^3
- Undetectable viral load
- Maintained on modern therapeutic regimens utilizing non-CYP interactive agents (i.e. excluding ritonavir)
- No history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Patients who received prior platinum or taxane chemotherapy are eligible
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. In addition, patients with any of the known cardiopulmonary disease, defined as follows, would be ineligible for this trial:
- Unstable angina
- Congestive heart failure (New York Heart Association [NYHA] class III or IV;);
- Myocardial infarction within 6 months prior to randomization (patients who had ischemic heart disease such as acute coronary syndrome [ACS], myocardial infarction, and/or revascularization greater than 6 months before randomization and who are without cardiac symptoms may enroll)
- Symptomatic cardiomyopathy
- Clinically symptomatic pulmonary hypertension requiring pharmacologic therapy
- Clinically significant arrhythmia, defined as:
  - History of polymorphic ventricular fibrillation or torsade de pointes,
  - Permanent atrial fibrillation, defined as continuous atrial fibrillation for >= 6 months,
  - Persistent atrial fibrillation, defined as sustained atrial fibrillation lasting > 7 days and/or requiring cardioversion in the 4 weeks before randomization,
  - Grade 3 atrial fibrillation defined as symptomatic and incompletely controlled medically, or controlled with device (e.g., pacemaker), or ablation
  - Patients with paroxysmal atrial fibrillation or grade < 3 atrial fibrillation for period of at least 6 months are permitted to enroll provided that their rate is controlled on a stable regimen
Patients must have the ability to understand and the willingness to sign a written informed consent document
Participants with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible

Exclusion Criteria:

Patients must not have had major surgery within 14 days before randomization. Patients with surgery planned during study period are ineligible
Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. Patients must also not expect to conceive or father children from the time of registration, while on study treatment, and until at least 4 months after the last dose of study treatment. All females of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
Women of childbearing potential and sexually active males must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and continue for at least 4 months after the last dose of protocol treatment
Male patients must not donate sperm during the course of this study or within 4 months after receiving their last dose of protocol treatment
Female patients must not donate eggs (ova) during the course of this study or within 4 months after receiving their last dose of protocol treatment
Patient must not have a prolonged rate corrected QT (QTc) interval >= 480 msec calculated according to institutional guideline
Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e. have residual toxicities > grade 1) are ineligible with the exception of alopecia
Patients with persistent >= grade 2 diarrhea lasting more than 3 days within 14 weeks of randomization are ineligible
Patients with known central nervous system (CNS) involvement are ineligible
Patients must not be receiving any other investigational agents
Patients must not have received chemotherapy or radiotherapy within 2 weeks prior to randomization. Prior treatment with radiation therapy involving >= 25% of hematopoietically active bone marrow will be ineligible
Patients must not have received immunotherapy within 8 weeks prior to randomization
Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to pevonedistat, carboplatin, or paclitaxel
Patient must not be receiving any treatment with clinically significant metabolic enzyme inducers within 14 days before the first dose of the study drug as below. Clinically significant metabolic enzyme inducers are not permitted during the study. Patients must not be receiving any medications or substances that are strong inducers of CYP3A4/5 (i.e. phenytoin, rifampin, St. Johns wort) or inhibitors of breast cancer resistance protein (BCRP) (i.e. cyclosporine). Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if a new medication need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product. Inhibitors of CYP3A4/5 are allowed
Patients must not have uncontrolled intercurrent illness
Patients must not have uncontrolled coagulopathy or bleeding disorder
Patients must not have active, uncontrolled infection or severe infectious disease such as severe pneumonia, meningitis, or septicemia
Patients with known moderate chronic obstructive pulmonary disease, interstitial lung disease, and pulmonary fibrosis are ineligible
Patients must not have psychiatric illness/social situations that would limit compliance with study requirements
Participants must not have had prior pevonedistat treatment

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 A (pevonedistat) Patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Drug: Pevonedistat Given IV Other Names: MLN4924 Nedd8-Activating Enzyme Inhibitor MLN4924
Experimental: Arm B (pevonedistat, paclitaxel, carboplatin) Patients receive pevonedistat IV over 1 hour on days 1, 3, and 5, paclitaxel IV over 3 hours on day 1, and carboplatin IV over 15-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Starting cycle 5, patients may receive pevonedistat monotherapy at the discretion of treating physician.	Drug: Carboplatin Given IV Other Names: Blastocarb Carboplat Carboplatin Hexal Carboplatino Carboplatinum Carbosin Carbosol Carbotec CBDCA Displata Ercar JM-8 Nealorin Novoplatinum Paraplatin Paraplatin AQ Paraplatine Platinwas Ribocarbo JM8 Drug: Paclitaxel Given IV Other Names: Taxol Anzatax Asotax Bristaxol Praxel Taxol Konzentrat Drug: Pevonedistat Given IV Other Names: MLN4924 Nedd8-Activating Enzyme Inhibitor MLN4924

Participant Group / Arm

Intervention / Treatment

Experimental: Arm A (pevonedistat)

Patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: Pevonedistat

Given IV

Other Names:

MLN4924
Nedd8-Activating Enzyme Inhibitor MLN4924

Experimental: Arm B (pevonedistat, paclitaxel, carboplatin)

Patients receive pevonedistat IV over 1 hour on days 1, 3, and 5, paclitaxel IV over 3 hours on day 1, and carboplatin IV over 15-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Starting cycle 5, patients may receive pevonedistat monotherapy at the discretion of treating physician.

Drug: Carboplatin

Given IV

Other Names:

Blastocarb
Carboplat
Carboplatin Hexal
Carboplatino
Carboplatinum
Carbosin
Carbosol
Carbotec
CBDCA
Displata
Ercar
JM-8
Nealorin
Novoplatinum
Paraplatin
Paraplatin AQ
Paraplatine
Platinwas
Ribocarbo
JM8

Drug: Paclitaxel

Given IV

Other Names:

Taxol
Anzatax
Asotax
Bristaxol
Praxel
Taxol Konzentrat

Drug: Pevonedistat

Given IV

Other Names:

MLN4924
Nedd8-Activating Enzyme Inhibitor MLN4924

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate Time Frame: 3 years	Will assess complete or partial response by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival Time Frame: 3 years	3 years
Progression-free survival Time Frame: 3 years	3 years
Incidence of adverse events Time Frame: Up to 30 days after the last dose of treatment	Up to 30 days after the last dose of treatment
Disease control rate Time Frame: 3 years	3 years
Clinical benefit rate Time Frame: 3 years	3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overexpression of NEDD8, NAE1, and UBC12 Time Frame: 3 years	Will perform immunohistochemistry on formalin-fixed paraffin-embedded (FFPE) tissue determine whether overexpression of NEDD8, NAE1, and UBC12 can predict response to treatment. Biomarker quantification will be calculated as a continuous variable (mean optical density) and also as ordered categories (ex. 0, 1+, 2+, or 3+). Biomarker quantification will then be correlated with treatment response. Descriptive statistics will primarily be generated to summarize the correlative data. Statistical significance will be determined by students' t-test for normally distributed data. If data distributions are not normal, non-parametric methods will be used (Wilcoxon rank sum test).	3 years
Mutation profile of cholangiocarcinomas with overexpression of the neddylation pathway Time Frame: 3 years		3 years
Specimen banking Time Frame: 3 years		3 years

Collaborators and Investigators

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

Sponsor

National Cancer Institute (NCI)

Investigators

Principal Investigator: Dustin A Deming, ECOG-ACRIN Cancer Research Group

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)

March 16, 2020

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

November 22, 2019

First Submitted That Met QC Criteria

November 22, 2019

First Posted (Actual)

November 25, 2019

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

NCI-2019-07769 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
U10CA180820 (U.S. NIH Grant/Contract)
EA2187 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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Recruiting

Modified Immune Cells (Autologous Dendritic Cells) and a Vaccine (Prevnar) After High-Dose External Beam Radiation Therapy in Treating Patients With Unresectable Liver Cancer

Stage III Intrahepatic Cholangiocarcinoma AJCC v8 | Unresectable Hepatocellular Carcinoma | Stage III Hepatocellular Carcinoma AJCC v8 | Stage IV Hepatocellular Carcinoma AJCC v8 | Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 | Unresectable Intrahepatic Cholangiocarcinoma

United States
Mayo Clinic
National Cancer Institute (NCI)

Not yet recruiting

Radioembolization With Tremelimumab and Durvalumab for Locally Advanced Unresectable or Oligo-Metastatic Intrahepatic Cholangiocarcinoma

Stage III Intrahepatic Cholangiocarcinoma AJCC v8 | Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 | Unresectable Intrahepatic Cholangiocarcinoma | Locally Advanced Intrahepatic Cholangiocarcinoma | Oligometastatic Intrahepatic Cholangiocarcinoma

United States
SWOG Cancer Research Network
National Cancer Institute (NCI)

Active, not recruiting

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

Stage III Intrahepatic Cholangiocarcinoma AJCC v8 | Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8 | Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8 | Stage III Gallbladder Cancer AJCC v8 | Stage IIIA Gallbladder Cancer AJCC v8 | Stage IIIB Gallbladder Cancer AJCC v8 | Unresectable Extrahepatic... and other conditions

United States
National Cancer Institute (NCI)

Recruiting

Testing the Combination of New Anti-cancer Drug Peposertib With Avelumab and Radiation Therapy for Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies

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...

United States

Clinical Trials on Carboplatin

Eisai Inc.

Completed

A Dose-Finding Study of E7389 in Combination With Carboplatin in Patients With Solid Tumors

Cancer

United States, Austria, India
Samyang Biopharmaceuticals Corporation

Completed

Determine MTD, Evaluate Efficacy and Safety of Genexol®-PM Plus Carboplatin With Advanced Ovarian Cancer

Ovarian Cancer
NHS Greater Glasgow and Clyde

Completed

Carboplatin in Treating Patients With Stage IC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Ovarian Cancer | Fallopian Tube Cancer | Primary Peritoneal Cavity Cancer

United Kingdom, Australia, New Zealand
Duke University

Completed

Carboplatin in Patients With Progressive Gliomas

Brain and Central Nervous System Tumors

United States, Canada
National Cancer Institute (NCI)

Completed

AZD2281 Plus Carboplatin to Treat Breast and Ovarian Cancer

Breast Cancer | Ovarian Cancer

United States
National Cancer Institute (NCI)
Children's Oncology Group

Completed

Lobradimil and Carboplatin in Treating Children With Brain Tumors

Brain and Central Nervous System Tumors

United States, Canada, Puerto Rico, Australia, Netherlands, New Zealand, Switzerland
All India Institute of Medical Sciences, New Delhi
Council of Scientific and Industrial Research, India

Unknown

Trial Comparing Two Carboplatin Doses in Groups C and D Intraocular Retinoblastoma

Intraocular Retinoblastoma

India
H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)

Completed

BMS-188797 and Carboplatin in Treating Patients With Advanced Nonhematologic Cancer

Unspecified Adult Solid Tumor, Protocol Specific

United States
Eli Lilly and Company

Completed

ALIMTA(Pemetrexed)/Cisplatin and ALIMTA(Pemetrexed)/Carboplatin in Extensive Stage Small Cell Lung Cancer.

Lung Neoplasms

United States
MEI Pharma, Inc.

Completed

OVATURE (OVArian TUmor REsponse) A Phase III Study of Weekly Carboplatin With and Without Phenoxodiol in Patients With Platinum-Resistant, Recurrent Epithelial Ovarian Cancer (OVATURE)

Peritoneal Neoplasms | Ovarian Cancer | Fallopian Tube Cancer

United States, Spain, Belgium, United Kingdom, Australia, Italy, Poland

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

A Phase 2 Study of Pevonedistat in Combination With Carboplatin and Paclitaxel in Advanced Intrahepatic Cholangiocarcinoma

Study Overview

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Clinical Trials on Stage III Intrahepatic Cholangiocarcinoma AJCC v8

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