Trametinib or Combination Chemotherapy in Treating Patients With Refractory or Advanced Biliary or Gallbladder Cancer or That Cannot Be Removed by Surgery (S1310)
August 11, 2017 updated by: National Cancer Institute (NCI)
Randomized Phase II Trial of Single Agent MEK Inhibitor Trametinib (GSK1120212) Vs 5-Fluorouracil or Capecitabine in Refractory Advanced Biliary Cancer
This randomized phase II trial studies how well trametinib or combination chemotherapy works in treating patients with refractory or advanced biliary or gallbladder cancer or that cannot be removed by surgery.
Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, and capecitabine, 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 yet known whether giving trametinib is more effective than combination chemotherapy in treating patients with biliary or gallbladder cancer.
Study Overview
Status
Completed
Conditions
- Hilar Cholangiocarcinoma
- Advanced Adult Hepatocellular Carcinoma
- Localized Non-Resectable Adult Liver Carcinoma
- Recurrent Adult Liver Carcinoma
- Recurrent Gallbladder Carcinoma
- Stage IV Distal Bile Duct Cancer
- Unresectable Extrahepatic Bile Duct Carcinoma
- Stage II Gallbladder Cancer
- Stage IIIA Gallbladder Cancer
- Stage IIIB Gallbladder Cancer
- Stage IVA Gallbladder Cancer
- Stage IVB Gallbladder Cancer
- Recurrent Childhood Liver Cancer
- BCLC Stage C Adult Hepatocellular Carcinoma
- Adult Cholangiocarcinoma
- BCLC Stage D Adult Hepatocellular Carcinoma
- Recurrent Extrahepatic Bile Duct Carcinoma
- Stage III Childhood Hepatocellular Carcinoma
- Stage IV Childhood Hepatocellular Carcinoma
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To assess overall survival (OS) in patients with refractory advanced biliary cancer randomized to Arm 1: trametinib compared to those randomized to Arm 2: chemotherapy (either 5-fluorouracil [fluorouracil] and leucovorin [leucovorin calcium] or capecitabine).
SECONDARY OBJECTIVES:
I. To determine the frequency and severity of adverse events of trametinib in this patient population.
II. To assess response rate (RR) and progression-free survival (PFS) in patients randomized to Arm 1: trametinib and patients randomized to Arm 2: chemotherapy (fluorouracil [5-FU] or capecitabine in this patient population).
TERTIARY OBJECTIVES:
I. To determine if a 16-gene expression signature is predictive of mitogen-activated protein kinase kinase (MEK) efficacy as evidenced by improved RR, PFS, and OS.
II. To evaluate the effects of trametinib on the inflammatory cytokine and explore potential associations with response rate and survival.
III. To estimate lean soft tissue and fat mass weight gain as a result of treatment with trametinib vs. capecitabine in patients with advanced refractory biliary cancer.
IV. To bank tissue samples for other future correlative studies including next generation sequencing and whole genome methylation assays. NOTE: These potential future correlative studies will not be performed until an amended protocol with relevant detailed information including specific arms and assays is approved by Cancer Therapy Evaluation Program (CTEP).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive trametinib orally (PO) once daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive 1 of 2 treatment regimens at the discretion of the investigator.
ARM IIA: Patients receive leucovorin calcium intravenously (IV) over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM IIB: Patients receive capecitabine PO twice daily (BID) on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years.
Study Type
Interventional
Enrollment (Actual)
53
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
-
-
Alaska
-
Anchorage, Alaska, United States, 99508
- Alaska Breast Care and Surgery 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
-
-
California
-
Anaheim, California, United States, 92807
- Kaiser Permanente-Anaheim
-
Auburn, California, United States, 95602
- Sutter Auburn Faith Hospital
-
Baldwin Park, California, United States, 91706
- Kaiser Permanente-Baldwin Park
-
Bellflower, California, United States, 90706
- Kaiser Permanente-Bellflower
-
Berkeley, California, United States, 94704
- Alta Bates Summit Medical Center-Herrick Campus
-
Burlingame, California, United States, 94010
- Mills - Peninsula Hospitals
-
Davis, California, United States, 95616
- Sutter Davis Hospital
-
Duarte, California, United States, 91010
- City of Hope Comprehensive Cancer Center
-
Fontana, California, United States, 92335
- Kaiser Permanente Hospital
-
Harbor City, California, United States, 90710
- Kaiser Permanente - Harbor City
-
Irvine, California, United States, 92618
- Kaiser Permanente-Irvine
-
Los Angeles, California, United States, 90033
- USC / Norris Comprehensive Cancer Center
-
Los Angeles, California, United States, 90033
- Los Angeles County-USC Medical Center
-
Los Angeles, California, United States, 90027
- Kaiser Permanente Los Angeles Medical Center
-
Los Angeles, California, United States, 90034
- Kaiser Permanente-Cadillac
-
Marysville, California, United States, 95901
- Fremont - Rideout Cancer Center
-
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
-
Novato, California, United States, 94945
- Sutter Cancer Research Consortium
-
Orange, California, United States, 92868
- UC Irvine Health/Chao Family Comprehensive Cancer Center
-
Palo Alto, California, United States, 94301
- Palo Alto Medical Foundation Health Care
-
Panorama City, California, United States, 91402
- Kaiser Permanente - Panorama City
-
Riverside, California, United States, 92505
- Kaiser Permanente-Riverside
-
Roseville, California, United States, 95661
- Sutter Roseville Medical Center
-
Sacramento, California, United States, 95817
- University of California Davis Comprehensive Cancer Center
-
Sacramento, California, United States, 95816
- Sutter General Hospital
-
San Diego, California, United States, 92120
- Kaiser Permanente-San Diego Zion
-
San Diego, California, United States, 92108
- Kaiser Permanente-San Diego Mission
-
San Francisco, California, United States, 94115
- California Pacific Medical Center-Pacific Campus
-
San Marcos, California, United States, 92069
- Kaiser Permanente-San Marcos
-
Santa Cruz, California, United States, 95065
- Palo Alto Medical Foundation-Santa Cruz
-
Santa Rosa, California, United States, 95403
- Sutter Pacific Medical Foundation
-
Sunnyvale, California, United States, 94086
- Palo Alto Medical Foundation-Sunnyvale
-
Vallejo, California, United States, 94589
- Sutter Solano Medical Center/Cancer Center
-
Woodland Hills, California, United States, 91367
- Kaiser Permanente
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado Cancer Center - Anschutz Cancer Pavilion
-
Colorado Springs, Colorado, United States, 80909
- Memorial Hospital Colorado Springs
-
-
Connecticut
-
Derby, Connecticut, United States, 06418
- Smilow Cancer Hospital-Derby Care Center
-
Guilford, Connecticut, United States, 06437
- Medical Oncology and Hematology Group PC-Guilford
-
Hartford, Connecticut, United States, 06105
- Smilow Cancer Hospital Care Center at Saint Francis
-
New Haven, Connecticut, United States, 06520
- Yale University
-
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
- Charlotte Hungerford Hospital Center for Cancer Care
-
Waterbury, Connecticut, United States, 06708
- Smilow Cancer Hospital-Waterbury Care Center
-
-
Florida
-
Gainesville, Florida, United States, 32610
- University of Florida
-
Tampa, Florida, United States, 33612
- Moffitt Cancer Center
-
-
Idaho
-
Boise, Idaho, United States, 83706
- Saint Alphonsus Cancer Care Center-Boise
-
Coeur d'Alene, Idaho, United States, 83814
- Kootenai Medical Center
-
Post Falls, Idaho, United States, 83854
- Kootenai Cancer Center
-
Sandpoint, Idaho, United States, 83864
- Kootenai Cancer Clinic
-
-
Illinois
-
Bloomington, Illinois, United States, 61704
- Illinois CancerCare-Bloomington
-
Bloomington, Illinois, United States, 61701
- Saint Joseph Medical Center
-
Canton, Illinois, United States, 61520
- Illinois CancerCare-Canton
-
Carbondale, Illinois, United States, 62902
- Memorial Hospital of Carbondale
-
Carthage, Illinois, United States, 62321
- Illinois CancerCare-Carthage
-
Centralia, Illinois, United States, 62801
- Centralia Oncology Clinic
-
Decatur, Illinois, United States, 62526
- Decatur Memorial Hospital
-
Decatur, Illinois, United States, 62526
- Cancer Care Center of Decatur
-
Effingham, Illinois, United States, 62401
- Crossroads Cancer Center
-
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
-
Kewanee, Illinois, United States, 61443
- Illinois CancerCare-Kewanee Clinic
-
Macomb, Illinois, United States, 61455
- Illinois CancerCare-Macomb
-
Maywood, Illinois, United States, 60153
- Loyola University Medical Center
-
Mount Vernon, Illinois, United States, 62864
- Good Samaritan Regional Health Center
-
Ottawa, Illinois, United States, 61350
- Illinois CancerCare-Ottawa Clinic
-
Ottawa, Illinois, United States, 61350
- Radiation Oncology of Northern Illinois
-
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, 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
-
Peoria, Illinois, United States, 61603
- Methodist Medical Center of Illinois
-
Peru, Illinois, United States, 61354
- Illinois CancerCare-Peru
-
Peru, Illinois, United States, 61354
- Valley Radiation Oncology
-
Princeton, Illinois, United States, 61356
- Illinois CancerCare-Princeton
-
Springfield, Illinois, United States, 62781
- Memorial Medical Center
-
Springfield, Illinois, United States, 62702
- Southern Illinois University School of Medicine
-
Springfield, Illinois, United States, 62702
- Central Illinois Hematology Oncology Center
-
Springfield, Illinois, United States, 62703
- Springfield Clinic
-
-
Indiana
-
Richmond, Indiana, United States, 47374
- Reid Health
-
-
Kansas
-
Chanute, Kansas, United States, 66720
- Cancer Center of Kansas - Chanute
-
Dodge City, Kansas, United States, 67801
- Cancer Center of Kansas - Dodge City
-
El Dorado, Kansas, United States, 67042
- Cancer Center of Kansas - El Dorado
-
Emporia, Kansas, United States, 66801
- Newman Regional Health
-
Fort Scott, Kansas, United States, 66701
- Cancer Center of Kansas - Fort Scott
-
Garden City, Kansas, United States, 67846
- Saint Catherine Hospital
-
Great Bend, Kansas, United States, 67530
- Saint Rose Ambulatory and Surgery Center
-
Hays, Kansas, United States, 67601
- Hays Medical Center
-
Independence, Kansas, United States, 67301
- Cancer Center of Kansas-Independence
-
Kansas City, Kansas, United States, 66160
- University of Kansas Cancer Center
-
Kansas City, Kansas, United States, 66112
- University of Kansas Cancer Center-West
-
Kingman, Kansas, United States, 67068
- Cancer Center of Kansas-Kingman
-
Lawrence, Kansas, United States, 66044
- Lawrence Memorial Hospital
-
Liberal, Kansas, United States, 67905
- Cancer Center of Kansas-Liberal
-
Manhattan, Kansas, United States, 66502
- Cancer Center of Kansas-Manhattan
-
McPherson, Kansas, United States, 67460
- Cancer Center of Kansas - McPherson
-
Newton, Kansas, United States, 67114
- Cancer Center of Kansas - Newton
-
Olathe, Kansas, United States, 66061
- Olathe Medical Center
-
Overland Park, Kansas, United States, 66210
- University of Kansas Cancer Center-Overland Park
-
Parsons, Kansas, United States, 67357
- Cancer Center of Kansas - Parsons
-
Pittsburg, Kansas, United States, 66762
- Via Christi Hospital-Pittsburg
-
Pratt, Kansas, United States, 67124
- Cancer Center of Kansas - Pratt
-
Salina, Kansas, United States, 67401
- Salina Regional Health Center
-
Salina, Kansas, United States, 67401
- Cancer Center of Kansas - Salina
-
Topeka, Kansas, United States, 66606
- Saint Francis Hospital and Medical Center - Topeka
-
Wellington, Kansas, United States, 67152
- Cancer Center of Kansas - Wellington
-
Wichita, Kansas, United States, 67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
-
Wichita, Kansas, United States, 67214
- Cancer Center of Kansas - Wichita
-
Wichita, Kansas, United States, 67208
- Associates In Womens Health
-
Wichita, Kansas, United States, 67214
- Wichita NCI Community Oncology Research Program
-
Wichita, Kansas, United States, 67214
- Via Christi Regional Medical Center
-
Winfield, Kansas, United States, 67156
- Cancer Center of Kansas - Winfield
-
-
Kentucky
-
Crestview Hills, Kentucky, United States, 41017
- Oncology Hematology Care Inc-Crestview
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02118
- Boston Medical Center
-
Burlington, Massachusetts, United States, 01805
- Lahey Hospital and Medical Center
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48106-0995
- Saint Joseph Mercy Hospital
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan Comprehensive Cancer Center
-
Ann Arbor, Michigan, United States, 48106
- Michigan Cancer Research Consortium NCORP
-
Battle Creek, Michigan, United States, 49017
- Bronson Battle Creek
-
Dearborn, Michigan, United States, 48124
- Beaumont Hospital-Dearborn
-
Detroit, Michigan, United States, 48236
- Saint John Hospital and Medical Center
-
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, 48502
- Hurley Medical Center
-
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
- Mercy Health Saint Mary's
-
Jackson, Michigan, United States, 49201
- Allegiance Health
-
Lansing, Michigan, United States, 48912
- Sparrow Hospital
-
Livonia, Michigan, United States, 48154
- Saint Mary Mercy Hospital
-
Muskegon, Michigan, United States, 49444
- Mercy Health Mercy Campus
-
Niles, Michigan, United States, 49120
- Lakeland Community Hospital
-
Pontiac, Michigan, United States, 48341
- Saint Joseph Mercy Oakland
-
Port Huron, Michigan, United States, 48060
- Lake Huron Medical Center
-
Reed City, Michigan, United States, 49677
- Spectrum Health Reed City Hospital
-
Saginaw, Michigan, United States, 48601
- Saint Mary's of Michigan
-
Saint Joseph, Michigan, United States, 49085
- Marie Yeager Cancer Center
-
Saint Joseph, Michigan, United States, 49085
- Lakeland Hospital
-
Traverse City, Michigan, United States, 49684
- Munson Medical Center
-
Warren, Michigan, United States, 48093
- Saint John Macomb-Oakland Hospital
-
-
Missouri
-
Bonne Terre, Missouri, United States, 63628
- Parkland Health Center-Bonne Terre
-
Cape Girardeau, Missouri, United States, 63703
- Saint Francis Medical Center
-
Cape Girardeau, Missouri, United States, 63703
- Southeast Cancer Center
-
Jefferson City, Missouri, United States, 65109
- Capital Region Medical Center-Goldschmidt Cancer Center
-
Kansas City, Missouri, United States, 64131
- The University of Kansas Cancer Center-South
-
Kansas City, Missouri, United States, 64108
- Truman Medical Center
-
Kansas City, Missouri, United States, 64154
- The University of Kansas Cancer Center-North
-
Lee's Summit, Missouri, United States, 64064
- The University of Kansas Cancer Center-Lee's Summit
-
Rolla, Missouri, United States, 65401
- Phelps County Regional Medical Center
-
Rolla, Missouri, United States, 65401
- Saint John's Clinic-Rolla-Cancer and Hematology
-
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, 63109
- Saint Louis Cancer and Breast Institute-South City
-
Sainte Genevieve, Missouri, United States, 63670
- Sainte Genevieve County Memorial Hospital
-
Springfield, Missouri, United States, 65804
- Cancer Research for the Ozarks NCORP
-
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
-
-
Montana
-
Billings, Montana, United States, 59101
- Billings Clinic Cancer Center
-
Billings, Montana, United States, 59101
- Saint Vincent Healthcare
-
Billings, Montana, United States, 59101
- Montana Cancer Consortium NCORP
-
Bozeman, Montana, United States, 59715
- Bozeman Deaconess Hospital
-
Butte, Montana, United States, 59701
- Saint James Community Hospital and Cancer Treatment Center
-
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
-
-
Nevada
-
Henderson, Nevada, United States, 89052
- Comprehensive Cancer Centers of Nevada - Henderson
-
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
-
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, 89144
- Comprehensive Cancer Centers of Nevada-Summerlin
-
Las Vegas, Nevada, United States, 89148
- Comprehensive Cancer Centers of Nevada
-
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, 89121
- Cancer Therapy and Integrative Medicine
-
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, 89148
- Cancer and Blood Specialists-Fort Apache
-
Las Vegas, Nevada, United States, 89106
- Nevada Cancer Research Foundation CCOP
-
Las Vegas, Nevada, United States, 89148
- 21st Century Oncology - Fort Apache
-
Las Vegas, Nevada, United States, 89182
- 21st Century Oncology - Vegas Tenaya
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87102
- University of New Mexico Cancer Center
-
Santa Fe, New Mexico, United States, 87505
- Christus Saint Vincent Regional Cancer Center
-
-
New York
-
New York, New York, United States, 10032
- Columbia University/Herbert Irving Cancer Center
-
Rochester, New York, United States, 14642
- University of Rochester
-
-
North Carolina
-
Asheville, North Carolina, United States, 28801
- Cancer Care of Western North Carolina
-
Asheville, North Carolina, United States, 28801
- Mission Hospital-Memorial Campus
-
Asheville, North Carolina, United States, 28803
- Asheville Hematology-Oncology Associates
-
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
-
Jacksonville, North Carolina, United States, 28546
- Southeastern Medical Oncology Center-Jacksonville
-
Statesville, North Carolina, United States, 28677
- Iredell Memorial Hospital
-
Wilson, North Carolina, United States, 27893
- Southeastern Medical Oncology Center-Wilson
-
Winston-Salem, North Carolina, United States, 27104
- Southeast Clinical Oncology Research (SCOR) Consortium NCORP
-
-
Ohio
-
Belpre, Ohio, United States, 45714
- Strecker Cancer Center-Belpre
-
Chillicothe, Ohio, United States, 45601
- Adena Regional Medical Center
-
Cincinnati, Ohio, United States, 45242
- Oncology Hematology Care Inc-Blue Ash
-
Cincinnati, Ohio, United States, 45202
- Oncology Hematology Care Inc-Eden Park
-
Cincinnati, Ohio, United States, 45211
- Oncology Hematology Care Inc-Mercy West
-
Cincinnati, Ohio, United States, 45236
- Oncology Hematology Care Inc-Kenwood
-
Cincinnati, Ohio, United States, 45230
- Oncology Hematology Care Inc - Anderson
-
Columbus, Ohio, United States, 43214
- Riverside Methodist Hospital
-
Columbus, Ohio, United States, 43210
- Ohio State University Comprehensive Cancer Center
-
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, 43215
- Grant Medical Center
-
Columbus, Ohio, United States, 43222
- Mount Carmel Health Center West
-
Columbus, Ohio, United States, 43215
- Columbus NCI Community Oncology Research Program
-
Dayton, Ohio, United States, 45406
- Good Samaritan Hospital - Dayton
-
Dayton, Ohio, United States, 45409
- Miami Valley Hospital
-
Dayton, Ohio, United States, 45415
- Samaritan North Health Center
-
Dayton, Ohio, United States, 45420
- Dayton NCI Community Oncology Research Program
-
Delaware, Ohio, United States, 43015
- Delaware Health Center-Grady Cancer Center
-
Delaware, Ohio, United States, 43015
- Delaware Radiation Oncology
-
Delaware, Ohio, United States, 43015
- Grady Memorial Hospital
-
Fairfield, Ohio, United States, 45014
- Oncology Hematology Care Inc-Healthplex
-
Findlay, Ohio, United States, 45840
- Blanchard Valley Hospital
-
Franklin, Ohio, United States, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
-
Greenville, Ohio, United States, 45331
- Wayne Hospital
-
Kettering, Ohio, United States, 45429
- Kettering Medical Center
-
Lancaster, Ohio, United States, 43130
- Fairfield Medical Center
-
Marietta, Ohio, United States, 45750
- Marietta Memorial 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
-
Portsmouth, Ohio, United States, 45662
- Southern Ohio Medical Center
-
Springfield, Ohio, United States, 45505
- Springfield Regional Medical Center
-
Troy, Ohio, United States, 45373
- Upper Valley Medical Center
-
Westerville, Ohio, United States, 43081
- Saint Ann's Hospital
-
Zanesville, Ohio, United States, 43701
- Genesis Healthcare System Cancer Care Center
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma Health Sciences Center
-
-
Oregon
-
Clackamas, Oregon, United States, 97015
- Clackamas Radiation Oncology Center
-
Milwaukie, Oregon, United States, 97222
- Providence Milwaukie Hospital
-
Newberg, Oregon, United States, 97132
- Providence Newberg Medical Center
-
Oregon City, Oregon, United States, 97045
- Providence Willamette Falls Medical Center
-
Portland, Oregon, United States, 97239
- Oregon Health and Science University
-
Portland, Oregon, United States, 97213
- Providence Portland Medical Center
-
Portland, Oregon, United States, 97225
- Providence Saint Vincent Medical Center
-
-
South Carolina
-
Charleston, South Carolina, United States, 29401
- Roper Hospital
-
Charleston, South Carolina, United States, 29403
- Charleston Hematology Oncology Associates-Roper
-
Charleston, South Carolina, United States, 29406
- Lowcountry Hematology Oncology PA-North Charleston
-
Charleston, South Carolina, United States, 29414
- Charleston Hematology Oncology Associates PA-St. Francis
-
Charleston, South Carolina, United States, 29414
- Lowcountry Hematology Oncology PA-West Ashley
-
Easley, South Carolina, United States, 29640
- Greenville Health System Cancer Institute-Easley
-
Greenville, South Carolina, United States, 29601
- Saint Francis Hospital
-
Greenville, South Carolina, United States, 29605
- Greenville Health System Cancer Institute-Andrews
-
Greenville, South Carolina, United States, 29605
- Greenville Health System Cancer Institute-Faris
-
Greenville, South Carolina, United States, 29605
- Greenville Memorial Hospital
-
Greenville, South Carolina, United States, 29615
- Greenville Health System Cancer Institute-Eastside
-
Greenville, South Carolina, United States, 29605
- Greenville Health System Cancer Institute-Butternut
-
Greer, South Carolina, United States, 29651
- Gibbs Cancer Center-Pelham
-
Greer, South Carolina, United States, 29650
- Greenville Health System Cancer Institute-Greer
-
Mount Pleasant, South Carolina, United States, 29464
- Lowcountry Hematology Oncology PA-Mount Pleasant
-
Seneca, South Carolina, United States, 29672
- Greenville Health System Cancer Institute-Seneca
-
Spartanburg, South Carolina, United States, 29303
- Spartanburg Medical Center
-
Spartanburg, South Carolina, United States, 29307
- Greenville Health System Cancer Institute-Spartanburg
-
-
Tennessee
-
Bristol, Tennessee, United States, 37620
- Wellmont Bristol Regional Medical Center
-
Johnson City, Tennessee, United States, 37604
- Wellmont Medical Associates Oncology and Hematology-Johnson City
-
Kingsport, Tennessee, United States, 37660
- Wellmont Holston Valley Hospital and Medical Center
-
Kingsport, Tennessee, United States, 37660
- Wellmont Medical Associates Oncology and Hematology-Kingsport
-
-
Texas
-
Amarillo, Texas, United States, 79106
- The Don and Sybil Harrington Cancer Center
-
Houston, Texas, United States, 77030
- The Methodist Hospital System
-
-
Utah
-
Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Institute/University of Utah
-
-
Virginia
-
Norton, Virginia, United States, 24273
- Southwest VA Regional Cancer Center
-
-
Washington
-
Longview, Washington, United States, 98632
- PeaceHealth Saint John Medical Center
-
Seattle, Washington, United States, 98122-4307
- Swedish Medical Center-First Hill
-
Vancouver, Washington, United States, 98664
- PeaceHealth Southwest Medical Center
-
-
Wyoming
-
Casper, Wyoming, United States, 82609
- Rocky Mountain Oncology
-
Cody, Wyoming, United States, 82414
- Big Horn Basin Cancer Center
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- DISEASE RELATED CRITERIA
- Patients must have histologically or cytologically documented carcinoma primary to the intra- or extra-hepatic biliary system or gall bladder with clinical and/or radiologic evidence of unresectable, locally advanced or metastatic disease; patients with ampullary carcinoma are not eligible
- Patients must have measurable disease; computed tomography (CT) scans or magnetic resonance imaging (MRI)s 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 (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
- PRIOR/CONCURRENT THERAPY CRITERIA
Patients must have completed any prior chemotherapy at least 21 days prior to registration and have recovered from any of the effects AND
- Patients must have experienced progression to no more than 1 prior regimen of systemic chemotherapy for advanced biliary cancer OR
- Patients who received adjuvant chemotherapy and had evidence of disease recurrence within 6 months of completion of the adjuvant treatment are also eligible; if patient received adjuvant treatment and had disease recurrence after 6 months, patients will only be eligible after failing one regimen of systemic chemotherapy used to treat the (unresectable or metastatic) disease recurrence
- Patients must not have been treated with prior MEK inhibitors; prior 5-FU or capecitabine treatment is allowed only if given as a radiosensitizer concurrently with radiation therapy at least 12 weeks prior to registration or if given as part of any adjuvant therapy regimen >= 12 months prior to study enrollment
- Patients must have no plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy or any other type of therapy (including herbal or natural supplements) for treatment of cancer while on this treatment protocol
For patients who have received prior cryotherapy, radiation therapy, radiofrequency ablation, therasphere, ethanol injection, transarterial chemoembolization (TACE) or photodynamic therapy, the following criteria must be met:
- 28 days have elapsed since that therapy (lesions that have not been treated with local therapy must be present and measureable)
- CLINICAL/LABORATORY CRITERIA
- Patients must have a Zubrod performance status of 0-1
- Absolute neutrophil count (ANC) > 1000/mcL
- Platelets > 100000/mcL
- Total bilirubin =< 2.0 x the institutional upper limit of normal limits (IULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both =< 3 x IULN; if liver metastases are present, AST and ALT must be =< 5 x IULN
- If the patient has had decompression of the biliary tree within the last 14 days, stability of the bilirubin level needs to be confirmed with two measurements that are within 5 to 7 days of each other; (the second measurement must be obtained within 7 days prior to registration;) both the first and second measurement must be =< 2.0 x IULN; stability is defined as the second measurement being no more than one point higher than the first
Patients must have adequate kidney function as evidenced by at least ONE of the following:
- Serum creatinine =< 1.5 x IULN within 28 days prior to registration
- Calculated creatinine clearance >= 50 ml/min for patients with creatinine level of 1.0-1.5 x IULN; the serum creatinine value used in the calculation must have been obtained within 28 days prior to registration
Patients with known history or current evidence of retinal vein occlusion (RVO) or retinal pigment epithelial detachment (RPED) are not eligible:
- History of RVO or RPED, or predisposing factors to RVO or RPED (e.g. such as uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such as hypertension, diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes)
Visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or RPED such as:
- Evidence of new optic disc cupping
- Evidence of new visual field defects
- Intraocular pressure > 21 mmHg
- NOTE: ophthalmic exam is required for all patients; this exam should not be performed until or unless it is very clear the patient is otherwise eligible for registration; this exam should not be performed until or unless it is very clear the patient is otherwise eligible for registration
- Patients must have echocardiogram and left ventricular ejection fraction (LVEF) >= institutional lower limit of normal (LLN) within 28 days prior to registration; this exam should not be performed until or unless it is very clear the patient is otherwise eligible for registration
- Patients must not have uncontrolled or clinically significant cardiovascular disease including: myocardial infarction within past 6 months; uncontrolled angina within past 6 months; class II-IV New York Heart Association (NYHA) congestive heart failure; grade 3 cardiac valve dysfunction; cardiac arrhythmia not controlled by medication; history of stroke or transient ischemic attack within 6 months; history of arterial thrombotic event (ATE) of any type in the past 6 months; treatment-refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mmHg which cannot be controlled with anti-hypertensive therapy; known intra-cardiac defibrillators; known cardiac metastases
- Patients must have an electrocardiogram (ECG) within 28 days prior to registration; patients must have corrected QT interval (QTc) =< 500 msec; this exam should not be performed until or unless it is very clear the patient is otherwise eligible for registration
- Must be able to swallow and retain orally-administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
- Must not have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trametinib, or excipients or to dimethyl sulfoxide (DMSO) or other agents used in study
- Must not have active hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (patients with chronic or cleared HBV and HCV infection are eligible)
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
- Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method while on study and for 4 months after discontinuation of study drug; 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
- 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 five years
- SPECIMEN SUBMISSION CRITERIA
- Patients must submit paraffin-embedded tissue and blood for banking within 28 days after registration; paraffin-embedded tissue from prior surgical resection or from a diagnostic biopsy is acceptable
- REGULATORY CRITERIA
- Patients or their legally authorized representative 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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Trametinib
Patients receive trametinib PO QD on days 1-21.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Correlative studies
Given PO
Other Names:
|
|
Experimental: Chemotherapy
Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15 (courses repeat every 28 days); or B) capecitabine PO BID on days 1-14 (courses repeat every 21 days).
Patients treated until disease progression or unacceptable toxicity.
|
Correlative studies
Given IV
Other Names:
Given PO
Other Names:
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Survival
Time Frame: Up to 2 years from registration
|
From date of registration to date of death due to any cause.
Patients last known to be alive are censored at date of last contact.
|
Up to 2 years from registration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Time Frame: Up to 2 years
|
Adverse event reporting followed the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0.
Only adverse events that are possibly, probably or definitely related to study drug are reported.
|
Up to 2 years
|
|
Objective Response Rate
Time Frame: Up to 2 years from registration
|
Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration.
Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration.
Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR.
Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.
|
Up to 2 years from registration
|
|
Progression-free Survival
Time Frame: Up to 2 years from registration
|
From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause.
Patients last known to be alive and progression free are censored at date of last contact.
|
Up to 2 years from registration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Richard Kim, Southwest Oncology 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
February 1, 2014
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
April 30, 2017
Study Registration Dates
First Submitted
January 20, 2014
First Submitted That Met QC Criteria
January 20, 2014
First Posted (Estimate)
January 22, 2014
Study Record Updates
Last Update Posted (Actual)
September 12, 2017
Last Update Submitted That Met QC Criteria
August 11, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Digestive System Neoplasms
- Liver Diseases
- Gallbladder Diseases
- Biliary Tract Diseases
- Bile Duct Diseases
- Biliary Tract Neoplasms
- Neoplasms, Ductal, Lobular, and Medullary
- Carcinoma
- Carcinoma, Hepatocellular
- Recurrence
- Cholangiocarcinoma
- Liver Neoplasms
- Klatskin Tumor
- Gallbladder Neoplasms
- Carcinoma, Ductal
- Bile Duct Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Micronutrients
- Protein Kinase Inhibitors
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Antidotes
- Vitamin B Complex
- Hematinics
- Fluorouracil
- Capecitabine
- Leucovorin
- Calcium
- Levoleucovorin
- Folic Acid
- Calcium, Dietary
- Trametinib
Other Study ID Numbers
- NCI-2013-02485 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U10CA032102 (U.S. NIH Grant/Contract)
- U10CA180888 (U.S. NIH Grant/Contract)
- S1310 (Other Identifier: CTEP)
- SWOG-S1310
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.
Clinical Trials on Hilar Cholangiocarcinoma
-
Zhongda HospitalCompleted
-
University of Kansas Medical CenterNational Cancer Institute (NCI)RecruitingStage 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 CholangiocarcinomaUnited States
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnUnresectable Extrahepatic Bile Duct Carcinoma | Recurrent Cholangiocarcinoma | Non-Resectable Cholangiocarcinoma | Stage III Intrahepatic Cholangiocarcinoma | Stage IIIA Hilar Cholangiocarcinoma | Stage IIIB Hilar Cholangiocarcinoma | Stage IVA Hilar Cholangiocarcinoma | Stage IVA Intrahepatic Cholangiocarcinoma and other conditionsUnited States
-
Khon Kaen UniversityUnknownUnresectable Hilar CholangiocarcinomaThailand
-
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co...TerminatedHilar CholangiocarcinomaChina
-
Zhujiang HospitalUnknownHilar CholangiocarcinomaChina
-
Khon Kaen UniversityCompletedHilar CholangiocarcinomaThailand
-
National Cancer Institute (NCI)RecruitingCholangiocarcinoma | 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 Cholangiocarcinoma...United States
-
Hospital Vall d'HebronRecruiting
-
Moscow Clinical Scientific CenterCompletedIntrahepatic Cholangiocarcinoma | Hilar Cholangiocarcinoma
Clinical Trials on Laboratory Biomarker Analysis
-
Children's Oncology GroupNational Cancer Institute (NCI)Completed
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)CompletedProstate Cancer
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Active, not recruitingLeukemia | Acute Lymphoblastic Leukemia | Acute Promyelocytic LeukemiaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedUntreated Adult Acute Lymphoblastic Leukemia | Untreated Childhood Acute Lymphoblastic LeukemiaUnited States, Canada, Australia, New Zealand, Puerto Rico, Switzerland
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedChildhood Acute Lymphoblastic Leukemia in Remission | Recurrent Childhood Acute Lymphoblastic LeukemiaUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedLung CancerUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Completed
-
Children's Oncology GroupNational Cancer Institute (NCI)WithdrawnClear Cell Renal Cell Carcinoma | Rhabdoid Tumor of the Kidney | Congenital Mesoblastic Nephroma | Childhood Kidney NeoplasmUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)WithdrawnBreast Carcinoma | BRCA1 Mutation Carrier | BRCA2 Mutation CarrierUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedWilms Tumor and Other Childhood Kidney TumorsUnited States