Trametinib or Combination Chemotherapy in Treating Patients With Refractory or Advanced Biliary or Gallbladder Cancer or That Cannot Be Removed by Surgery

PHASE2CompletedINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

January 31, 2017

Study Completion Date

April 30, 2017

Conditions
Adult CholangiocarcinomaAdvanced Adult Hepatocellular CarcinomaBCLC Stage C Adult Hepatocellular CarcinomaBCLC Stage D Adult Hepatocellular CarcinomaHilar CholangiocarcinomaLocalized Non-Resectable Adult Liver CarcinomaRecurrent Adult Liver CarcinomaRecurrent Childhood Liver CancerRecurrent Extrahepatic Bile Duct CarcinomaRecurrent Gallbladder CarcinomaStage II Gallbladder CancerStage III Childhood Hepatocellular CarcinomaStage IIIA Gallbladder CancerStage IIIB Gallbladder CancerStage IV Childhood Hepatocellular CarcinomaStage IV Distal Bile Duct CancerStage IVA Gallbladder CancerStage IVB Gallbladder CancerUnresectable Extrahepatic Bile Duct Carcinoma
Interventions
DRUG

Capecitabine

Given PO

DRUG

Fluorouracil

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Leucovorin Calcium

Given IV

DRUG

Trametinib

Given PO

Trial Locations (295)

10032

Columbia University/Herbert Irving Cancer Center, New York

14642

University of Rochester, Rochester

24273

Southwest VA Regional Cancer Center, Norton

27104

Southeast Clinical Oncology Research (SCOR) Consortium NCORP, Winston-Salem

27534

Southeastern Medical Oncology Center-Goldsboro, Goldsboro

Wayne Memorial Hospital, Goldsboro

27893

Southeastern Medical Oncology Center-Wilson, Wilson

28328

Southeastern Medical Oncology Center-Clinton, Clinton

28546

Southeastern Medical Oncology Center-Jacksonville, Jacksonville

28677

Iredell Memorial Hospital, Statesville

28801

Cancer Care of Western North Carolina, Asheville

Mission Hospital-Memorial Campus, Asheville

28803

Asheville Hematology-Oncology Associates, Asheville

29303

Spartanburg Medical Center, Spartanburg

29307

Greenville Health System Cancer Institute-Spartanburg, Spartanburg

29401

Roper Hospital, Charleston

29403

Charleston Hematology Oncology Associates-Roper, Charleston

29406

Lowcountry Hematology Oncology PA-North Charleston, Charleston

29414

Charleston Hematology Oncology Associates PA-St. Francis, Charleston

Lowcountry Hematology Oncology PA-West Ashley, Charleston

29464

Lowcountry Hematology Oncology PA-Mount Pleasant, Mt. Pleasant

29601

Saint Francis Hospital, Greenville

29605

Greenville Health System Cancer Institute-Andrews, Greenville

Greenville Health System Cancer Institute-Butternut, Greenville

Greenville Health System Cancer Institute-Faris, Greenville

Greenville Memorial Hospital, Greenville

29615

Greenville Health System Cancer Institute-Eastside, Greenville

29640

Greenville Health System Cancer Institute-Easley, Easley

29650

Greenville Health System Cancer Institute-Greer, Greer

29651

Gibbs Cancer Center-Pelham, Greer

29672

Greenville Health System Cancer Institute-Seneca, Seneca

32610

University of Florida, Gainesville

33612

Moffitt Cancer Center, Tampa

37604

Wellmont Medical Associates Oncology and Hematology-Johnson City, Johnson City

37620

Wellmont Bristol Regional Medical Center, Bristol

37660

Wellmont Holston Valley Hospital and Medical Center, Kingsport

Wellmont Medical Associates Oncology and Hematology-Kingsport, Kingsport

41017

Oncology Hematology Care Inc-Crestview, Crestview Hills

43015

Delaware Health Center-Grady Cancer Center, Delaware

Delaware Radiation Oncology, Delaware

Grady Memorial Hospital, Delaware

43050

Knox Community Hospital, Mount Vernon

43055

Licking Memorial Hospital, Newark

Newark Radiation Oncology, Newark

43081

Saint Ann's Hospital, Westerville

43130

Fairfield Medical Center, Lancaster

43210

Ohio State University Comprehensive Cancer Center, Columbus

43214

Columbus Oncology and Hematology Associates Inc, Columbus

Riverside Methodist Hospital, Columbus

43215

Columbus NCI Community Oncology Research Program, Columbus

Grant Medical Center, Columbus

43219

The Mark H Zangmeister Center, Columbus

43222

Mount Carmel Health Center West, Columbus

43228

Doctors Hospital, Columbus

43701

Genesis Healthcare System Cancer Care Center, Zanesville

45014

Oncology Hematology Care Inc-Healthplex, Fairfield

45202

Oncology Hematology Care Inc-Eden Park, Cincinnati

45211

Oncology Hematology Care Inc-Mercy West, Cincinnati

45230

Oncology Hematology Care Inc - Anderson, Cincinnati

45236

Oncology Hematology Care Inc-Kenwood, Cincinnati

45242

Oncology Hematology Care Inc-Blue Ash, Cincinnati

45331

Wayne Hospital, Greenville

45373

Upper Valley Medical Center, Troy

45406

Good Samaritan Hospital - Dayton, Dayton

45409

Miami Valley Hospital, Dayton

45415

Samaritan North Health Center, Dayton

45420

Dayton NCI Community Oncology Research Program, Dayton

45429

Kettering Medical Center, Kettering

45505

Springfield Regional Medical Center, Springfield

45601

Adena Regional Medical Center, Chillicothe

45662

Southern Ohio Medical Center, Portsmouth

45714

Strecker Cancer Center-Belpre, Belpre

45750

Marietta Memorial Hospital, Marietta

45840

Blanchard Valley Hospital, Findlay

47374

Reid Health, Richmond

48060

Lake Huron Medical Center, Port Huron

48093

Saint John Macomb-Oakland Hospital, Warren

48106

Michigan Cancer Research Consortium NCORP, Ann Arbor

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

48124

Beaumont Hospital-Dearborn, Dearborn

48154

Saint Mary Mercy Hospital, Livonia

48201

Wayne State University/Karmanos Cancer Institute, Detroit

48236

Saint John Hospital and Medical Center, Detroit

48334

Weisberg Cancer Treatment Center, Farmington Hills

48341

Saint Joseph Mercy Oakland, Pontiac

48502

Hurley Medical Center, Flint

48503

Genesys Hurley Cancer Institute, Flint

48601

Saint Mary's of Michigan, Saginaw

48912

Sparrow Hospital, Lansing

49017

Bronson Battle Creek, Battle Creek

49085

Lakeland Hospital, Saint Joseph

Marie Yeager Cancer Center, Saint Joseph

49120

Lakeland Community Hospital, Niles

49201

Allegiance Health, Jackson

49444

Mercy Health Mercy Campus, Muskegon

49503

Mercy Health Saint Mary's, Grand Rapids

Spectrum Health at Butterworth Campus, Grand Rapids

49677

Spectrum Health Reed City Hospital, Reed City

49684

Munson Medical Center, Traverse City

59101

Billings Clinic Cancer Center, Billings

Montana Cancer Consortium NCORP, Billings

Saint Vincent Healthcare, Billings

59405

Benefis Healthcare- Sletten Cancer Institute, Great Falls

59601

Saint Peter's Community Hospital, Helena

59701

Saint James Community Hospital and Cancer Treatment Center, Butte

59715

Bozeman Deaconess Hospital, Bozeman

59802

Saint Patrick Hospital - Community Hospital, Missoula

59804

Community Medical Hospital, Missoula

59901

Kalispell Regional Medical Center, Kalispell

60153

Loyola University Medical Center, Maywood

61350

Illinois CancerCare-Ottawa Clinic, Ottawa

Radiation Oncology of Northern Illinois, Ottawa

61354

Illinois CancerCare-Peru, Peru

Valley Radiation Oncology, Peru

61356

Illinois CancerCare-Princeton, Princeton

61401

Illinois CancerCare-Galesburg, Galesburg

Western Illinois Cancer Treatment Center, Galesburg

61443

Illinois CancerCare-Kewanee Clinic, Kewanee

61455

Illinois CancerCare-Macomb, Macomb

61520

Illinois CancerCare-Canton, Canton

61530

Illinois CancerCare-Eureka, Eureka

61554

Illinois CancerCare-Pekin, Pekin

OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center, Pekin

61603

Methodist Medical Center of Illinois, Peoria

61615

Illinois CancerCare-Peoria, Peoria

OSF Saint Francis Radiation Oncology at Peoria Cancer Center, Peoria

61637

OSF Saint Francis Medical Center, Peoria

61701

Saint Joseph Medical Center, Bloomington

61704

Illinois CancerCare-Bloomington, Bloomington

62321

Illinois CancerCare-Carthage, Carthage

62401

Crossroads Cancer Center, Effingham

62526

Cancer Care Center of Decatur, Decatur

Decatur Memorial Hospital, Decatur

62702

Central Illinois Hematology Oncology Center, Springfield

Southern Illinois University School of Medicine, Springfield

62703

Springfield Clinic, Springfield

62781

Memorial Medical Center, Springfield

62801

Centralia Oncology Clinic, Centralia

62864

Good Samaritan Regional Health Center, Mount Vernon

62902

Memorial Hospital of Carbondale, Carbondale

63080

Missouri Baptist Sullivan Hospital, Sullivan

63109

Saint Louis Cancer and Breast Institute-South City, St Louis

63127

Missouri Baptist Outpatient Center-Sunset Hills, Sunset Hills

63131

Missouri Baptist Medical Center, St Louis

63141

Mercy Hospital Saint Louis, St Louis

63628

Parkland Health Center-Bonne Terre, Bonne Terre

63670

Sainte Genevieve County Memorial Hospital, Sainte Genevieve

63703

Saint Francis Medical Center, Cape Girardeau

Southeast Cancer Center, Cape Girardeau

64064

The University of Kansas Cancer Center-Lee's Summit, Lee's Summit

64108

Truman Medical Center, Kansas City

64131

The University of Kansas Cancer Center-South, Kansas City

64154

The University of Kansas Cancer Center-North, Kansas City

65109

Capital Region Medical Center-Goldschmidt Cancer Center, Jefferson City

65401

Phelps County Regional Medical Center, Rolla

Saint John's Clinic-Rolla-Cancer and Hematology, Rolla

65804

Cancer Research for the Ozarks NCORP, Springfield

Mercy Hospital Springfield, Springfield

65807

CoxHealth South Hospital, Springfield

66044

Lawrence Memorial Hospital, Lawrence

66061

Olathe Medical Center, Olathe

66112

University of Kansas Cancer Center-West, Kansas City

66160

University of Kansas Cancer Center, Kansas City

66210

University of Kansas Cancer Center-Overland Park, Overland Park

66502

Cancer Center of Kansas-Manhattan, Manhattan

66606

Saint Francis Hospital and Medical Center - Topeka, Topeka

66701

Cancer Center of Kansas - Fort Scott, Fort Scott

66720

Cancer Center of Kansas - Chanute, Chanute

66762

Via Christi Hospital-Pittsburg, Pittsburg

66801

Newman Regional Health, Emporia

67042

Cancer Center of Kansas - El Dorado, El Dorado

67068

Cancer Center of Kansas-Kingman, Kingman

67114

Cancer Center of Kansas - Newton, Newton

67124

Cancer Center of Kansas - Pratt, Pratt

67152

Cancer Center of Kansas - Wellington, Wellington

67156

Cancer Center of Kansas - Winfield, Winfield

67208

Associates In Womens Health, Wichita

Cancer Center of Kansas-Wichita Medical Arts Tower, Wichita

67214

Cancer Center of Kansas - Wichita, Wichita

Via Christi Regional Medical Center, Wichita

Wichita NCI Community Oncology Research Program, Wichita

67301

Cancer Center of Kansas-Independence, Independence

67357

Cancer Center of Kansas - Parsons, Parsons

67401

Cancer Center of Kansas - Salina, Salina

Salina Regional Health Center, Salina

67460

Cancer Center of Kansas - McPherson, McPherson

67530

Saint Rose Ambulatory and Surgery Center, Great Bend

67601

Hays Medical Center, Hays

67801

Cancer Center of Kansas - Dodge City, Dodge City

67846

Saint Catherine Hospital, Garden City

67905

Cancer Center of Kansas-Liberal, Liberal

73104

University of Oklahoma Health Sciences Center, Oklahoma City

77030

The Methodist Hospital System, Houston

79106

The Don and Sybil Harrington Cancer Center, Amarillo

80045

University of Colorado Cancer Center - Anschutz Cancer Pavilion, Aurora

80909

Memorial Hospital Colorado Springs, Colorado Springs

82414

Big Horn Basin Cancer Center, Cody

Billings Clinic-Cody, Cody

82609

Rocky Mountain Oncology, Casper

82801

Welch Cancer Center, Sheridan

83706

Saint Alphonsus Cancer Care Center-Boise, Boise

83814

Kootenai Medical Center, Coeur d'Alene

83854

Kootenai Cancer Center, Post Falls

83864

Kootenai Cancer Clinic, Sandpoint

84112

Huntsman Cancer Institute/University of Utah, Salt Lake City

87102

University of New Mexico Cancer Center, Albuquerque

87505

Christus Saint Vincent Regional Cancer Center, Santa Fe

89052

Cancer and Blood Specialists-Henderson, Henderson

Comprehensive Cancer Centers of Nevada - Henderson, Henderson

Las Vegas Cancer Center-Henderson, Henderson

89074

21st Century Oncology - Henderson, Henderson

Comprehensive Cancer Centers of Nevada-Southeast Henderson, Henderson

89102

University Medical Center of Southern Nevada, Las Vegas

89106

Cancer and Blood Specialists-Shadow, Las Vegas

Nevada Cancer Research Foundation CCOP, Las Vegas

Radiation Oncology Centers of Nevada Central, Las Vegas

89109

21st Century Oncology, Las Vegas

HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway, Las Vegas

89113

HealthCare Partners Medical Group Oncology/Hematology-San Martin, Las Vegas

89119

Radiation Oncology Centers of Nevada Southeast, Las Vegas

89121

Cancer Therapy and Integrative Medicine, Las Vegas

89128

Cancer and Blood Specialists-Tenaya, Las Vegas

Comprehensive Cancer Centers of Nevada - Northwest, Las Vegas

HealthCare Partners Medical Group Oncology/Hematology-Tenaya, Las Vegas

89144

Comprehensive Cancer Centers of Nevada-Summerlin, Las Vegas

89148

21st Century Oncology - Fort Apache, Las Vegas

Cancer and Blood Specialists-Fort Apache, Las Vegas

Comprehensive Cancer Centers of Nevada, Las Vegas

89149

HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills, Las Vegas

89169

Comprehensive Cancer Centers of Nevada - Central Valley, Las Vegas

89182

21st Century Oncology - Vegas Tenaya, Las Vegas

90027

Kaiser Permanente Los Angeles Medical Center, Los Angeles

90033

Los Angeles County-USC Medical Center, Los Angeles

USC / Norris Comprehensive Cancer Center, Los Angeles

90034

Kaiser Permanente-Cadillac, Los Angeles

90706

Kaiser Permanente-Bellflower, Bellflower

90710

Kaiser Permanente - Harbor City, Harbor City

91010

City of Hope Comprehensive Cancer Center, Duarte

91367

Kaiser Permanente, Woodland Hills

91402

Kaiser Permanente - Panorama City, Panorama City

91706

Kaiser Permanente-Baldwin Park, Baldwin Park

92069

Kaiser Permanente-San Marcos, San Marcos

92108

Kaiser Permanente-San Diego Mission, San Diego

92120

Kaiser Permanente-San Diego Zion, San Diego

92335

Kaiser Permanente Hospital, Fontana

92505

Kaiser Permanente-Riverside, Riverside

92618

Kaiser Permanente-Irvine, Irvine

92807

Kaiser Permanente-Anaheim, Anaheim

92868

UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange

94010

Mills - Peninsula Hospitals, Burlingame

94040

Palo Alto Medical Foundation-Camino Division, Mountain View

Palo Alto Medical Foundation-Gynecologic Oncology, Mountain View

94086

Palo Alto Medical Foundation-Sunnyvale, Sunnyvale

94115

California Pacific Medical Center-Pacific Campus, San Francisco

94301

Palo Alto Medical Foundation Health Care, Palo Alto

94589

Sutter Solano Medical Center/Cancer Center, Vallejo

94704

Alta Bates Summit Medical Center-Herrick Campus, Berkeley

94945

Sutter Cancer Research Consortium, Novato

95065

Palo Alto Medical Foundation-Santa Cruz, Santa Cruz

95355

Memorial Medical Center, Modesto

95403

Sutter Pacific Medical Foundation, Santa Rosa

95602

Sutter Auburn Faith Hospital, Auburn

95616

Sutter Davis Hospital, Davis

95661

Sutter Roseville Medical Center, Roseville

95816

Sutter General Hospital, Sacramento

95817

University of California Davis Comprehensive Cancer Center, Sacramento

95901

Fremont - Rideout Cancer Center, Marysville

97015

Clackamas Radiation Oncology Center, Clackamas

97045

Providence Willamette Falls Medical Center, Oregon City

97132

Providence Newberg Medical Center, Newberg

97213

Providence Portland Medical Center, Portland

97222

Providence Milwaukie Hospital, Milwaukie

97225

Providence Saint Vincent Medical Center, Portland

97239

Oregon Health and Science University, Portland

98632

PeaceHealth Saint John Medical Center, Longview

98664

PeaceHealth Southwest Medical Center, Vancouver

99508

Alaska Breast Care and Surgery LLC, Anchorage

Alaska Women's Cancer Care, Anchorage

Anchorage Oncology Centre, Anchorage

Katmai Oncology Group, Anchorage

Providence Alaska Medical Center, Anchorage

06418

Smilow Cancer Hospital-Derby Care Center, Derby

06437

Medical Oncology and Hematology Group PC-Guilford, Guilford

06105

Smilow Cancer Hospital Care Center at Saint Francis, Hartford

06520

Yale University, New Haven

06473

Yale-New Haven Hospital North Haven Medical Center, North Haven

06477

Smilow Cancer Hospital-Orange Care Center, Orange

06790

Charlotte Hungerford Hospital Center for Cancer Care, Torrington

06708

Smilow Cancer Hospital-Waterbury Care Center, Waterbury

02118

Boston Medical Center, Boston

01805

Lahey Hospital and Medical Center, Burlington

48106-0995

Saint Joseph Mercy Hospital, Ann Arbor

89148-2405

Las Vegas Cancer Center-Medical Center, Las Vegas

45005-1066

Atrium Medical Center-Middletown Regional Hospital, Franklin

98122-4307

Swedish Medical Center-First Hill, Seattle

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT02042443 - Trametinib or Combination Chemotherapy in Treating Patients With Refractory or Advanced Biliary or Gallbladder Cancer or That Cannot Be Removed by Surgery | Biotech Hunter | Biotech Hunter