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Trametinib or Combination Chemotherapy in Treating Patients With Refractory or Advanced Biliary or Gallbladder Cancer or That Cannot Be Removed by Surgery (S1310)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02042443
First Posted: January 22, 2014
Last Update Posted: September 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
  Purpose
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.

Condition Intervention Phase
Adult Cholangiocarcinoma Advanced Adult Hepatocellular Carcinoma BCLC Stage C Adult Hepatocellular Carcinoma BCLC Stage D Adult Hepatocellular Carcinoma Hilar Cholangiocarcinoma Localized Non-Resectable Adult Liver Carcinoma Recurrent Adult Liver Carcinoma Recurrent Childhood Liver Cancer Recurrent Extrahepatic Bile Duct Carcinoma Recurrent Gallbladder Carcinoma Stage II Gallbladder Cancer Stage III Childhood Hepatocellular Carcinoma Stage IIIA Gallbladder Cancer Stage IIIB Gallbladder Cancer Stage IV Childhood Hepatocellular Carcinoma Stage IV Distal Bile Duct Cancer Stage IVA Gallbladder Cancer Stage IVB Gallbladder Cancer Unresectable Extrahepatic Bile Duct Carcinoma Drug: Capecitabine Drug: Fluorouracil Other: Laboratory Biomarker Analysis Drug: Leucovorin Calcium Drug: Trametinib Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Single Agent MEK Inhibitor Trametinib (GSK1120212) Vs 5-Fluorouracil or Capecitabine in Refractory Advanced Biliary Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • 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.

  • 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.


Enrollment: 53
Study Start Date: February 2014
Study Completion Date: April 30, 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Trametinib
Given PO
Other Names:
  • GSK1120212
  • JTP-74057
  • MEK Inhibitor GSK1120212
  • Mekinist
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.
Drug: Capecitabine
Given PO
Other Names:
  • Ro 09-1978/000
  • Xeloda
Drug: Fluorouracil
Given IV
Other Names:
  • 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
  • 5-Fluorouracil
  • 5-Fluracil
  • 5-FU
  • AccuSite
  • Carac
  • Fluoro Uracil
  • Fluouracil
  • Flurablastin
  • Fluracedyl
  • Fluracil
  • Fluril
  • Fluroblastin
  • Ribofluor
  • Ro 2-9757
  • Ro-2-9757
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Leucovorin Calcium
Given IV
Other Names:
  • Adinepar
  • Calcifolin
  • Calcium (6S)-Folinate
  • Calcium Folinate
  • Calcium Leucovorin
  • Calfolex
  • Calinat
  • Cehafolin
  • Citofolin
  • Citrec
  • Citrovorum Factor
  • Cromatonbic Folinico
  • Dalisol
  • Disintox
  • Divical
  • Ecofol
  • Emovis
  • Factor, Citrovorum
  • Flynoken A
  • Folaren
  • Folaxin
  • FOLI-cell
  • Foliben
  • Folidan
  • Folidar
  • Folinac
  • Folinate Calcium
  • folinic acid
  • Folinic Acid Calcium Salt Pentahydrate
  • Folinoral
  • Folinvit
  • Foliplus
  • Folix
  • Imo
  • Lederfolat
  • Lederfolin
  • Leucosar
  • leucovorin
  • Rescufolin
  • Rescuvolin
  • Tonofolin
  • Wellcovorin

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02042443


  Hide Study Locations
Locations
United States, Alaska
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
Anchorage, Alaska, United States, 99508
United States, California
Kaiser Permanente-Anaheim
Anaheim, California, United States, 92807
Sutter Auburn Faith Hospital
Auburn, California, United States, 95602
Kaiser Permanente-Baldwin Park
Baldwin Park, California, United States, 91706
Kaiser Permanente-Bellflower
Bellflower, California, United States, 90706
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States, 94704
Mills - Peninsula Hospitals
Burlingame, California, United States, 94010
Sutter Davis Hospital
Davis, California, United States, 95616
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Kaiser Permanente Hospital
Fontana, California, United States, 92335
Kaiser Permanente - Harbor City
Harbor City, California, United States, 90710
Kaiser Permanente-Irvine
Irvine, California, United States, 92618
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
Los Angeles County-USC Medical Center
Los Angeles, California, United States, 90033
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Kaiser Permanente-Cadillac
Los Angeles, California, United States, 90034
Fremont - Rideout Cancer Center
Marysville, California, United States, 95901
Memorial Medical Center
Modesto, California, United States, 95355
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States, 94040
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, United States, 94040
Sutter Cancer Research Consortium
Novato, California, United States, 94945
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States, 94301
Kaiser Permanente - Panorama City
Panorama City, California, United States, 91402
Kaiser Permanente-Riverside
Riverside, California, United States, 92505
Sutter Roseville Medical Center
Roseville, California, United States, 95661
Sutter General Hospital
Sacramento, California, United States, 95816
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Kaiser Permanente-San Diego Mission
San Diego, California, United States, 92108
Kaiser Permanente-San Diego Zion
San Diego, California, United States, 92120
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States, 94115
Kaiser Permanente-San Marcos
San Marcos, California, United States, 92069
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California, United States, 95065
Sutter Pacific Medical Foundation
Santa Rosa, California, United States, 95403
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, United States, 94086
Sutter Solano Medical Center/Cancer Center
Vallejo, California, United States, 94589
Kaiser Permanente
Woodland Hills, California, United States, 91367
United States, Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
Memorial Hospital Colorado Springs
Colorado Springs, Colorado, United States, 80909
United States, Connecticut
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, United States, 06418
Medical Oncology and Hematology Group PC-Guilford
Guilford, Connecticut, United States, 06437
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States, 06105
Yale University
New Haven, Connecticut, United States, 06520
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, United States, 06473
Smilow Cancer Hospital-Orange Care Center
Orange, Connecticut, United States, 06477
Charlotte Hungerford Hospital Center for Cancer Care
Torrington, Connecticut, United States, 06790
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, United States, 06708
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States, 83706
Kootenai Medical Center
Coeur d'Alene, Idaho, United States, 83814
Kootenai Cancer Center
Post Falls, Idaho, United States, 83854
Kootenai Cancer Clinic
Sandpoint, Idaho, United States, 83864
United States, Illinois
Saint Joseph Medical Center
Bloomington, Illinois, United States, 61701
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States, 61704
Illinois CancerCare-Canton
Canton, Illinois, United States, 61520
Memorial Hospital of Carbondale
Carbondale, Illinois, United States, 62902
Illinois CancerCare-Carthage
Carthage, Illinois, United States, 62321
Centralia Oncology Clinic
Centralia, Illinois, United States, 62801
Cancer Care Center of Decatur
Decatur, Illinois, United States, 62526
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Crossroads Cancer Center
Effingham, Illinois, United States, 62401
Illinois CancerCare-Eureka
Eureka, Illinois, United States, 61530
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States, 61401
Western Illinois Cancer Treatment Center
Galesburg, Illinois, United States, 61401
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States, 61443
Illinois CancerCare-Macomb
Macomb, Illinois, United States, 61455
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States, 62864
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Radiation Oncology of Northern Illinois
Ottawa, Illinois, United States, 61350
Illinois CancerCare-Pekin
Pekin, Illinois, United States, 61554
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, United States, 61554
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61603
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, United States, 61615
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Illinois CancerCare-Peru
Peru, Illinois, United States, 61354
Valley Radiation Oncology
Peru, Illinois, United States, 61354
Illinois CancerCare-Princeton
Princeton, Illinois, United States, 61356
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62702
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Springfield Clinic
Springfield, Illinois, United States, 62703
Memorial Medical Center
Springfield, Illinois, United States, 62781
United States, Indiana
Reid Health
Richmond, Indiana, United States, 47374
United States, Kansas
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States, 67042
Newman Regional Health
Emporia, Kansas, United States, 66801
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Saint Catherine Hospital
Garden City, Kansas, United States, 67846
Saint Rose Ambulatory and Surgery Center
Great Bend, Kansas, United States, 67530
Hays Medical Center
Hays, Kansas, United States, 67601
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
University of Kansas Cancer Center-West
Kansas City, Kansas, United States, 66112
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States, 67905
Cancer Center of Kansas-Manhattan
Manhattan, Kansas, United States, 66502
Cancer Center of Kansas - McPherson
McPherson, Kansas, United States, 67460
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Olathe Medical Center
Olathe, Kansas, United States, 66061
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States, 66210
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States, 67357
Via Christi Hospital-Pittsburg
Pittsburg, Kansas, United States, 66762
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67401
Salina Regional Health Center
Salina, Kansas, United States, 67401
Saint Francis Hospital and Medical Center - Topeka
Topeka, Kansas, United States, 66606
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Associates In Womens Health
Wichita, Kansas, United States, 67208
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States, 67214
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Wichita NCI Community Oncology Research Program
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Kentucky
Oncology Hematology Care Inc-Crestview
Crestview Hills, Kentucky, United States, 41017
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805
United States, Michigan
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, United States, 48106
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Bronson Battle Creek
Battle Creek, Michigan, United States, 49017
Beaumont Hospital-Dearborn
Dearborn, Michigan, United States, 48124
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States, 48334
Hurley Medical Center
Flint, Michigan, United States, 48502
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
Allegiance Health
Jackson, Michigan, United States, 49201
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Mercy Health Mercy Campus
Muskegon, Michigan, United States, 49444
Lakeland Community Hospital
Niles, Michigan, United States, 49120
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341
Lake Huron Medical Center
Port Huron, Michigan, United States, 48060
Spectrum Health Reed City Hospital
Reed City, Michigan, United States, 49677
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Lakeland Hospital
Saint Joseph, Michigan, United States, 49085
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States, 49085
Munson Medical Center
Traverse City, Michigan, United States, 49684
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
United States, Missouri
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, United States, 63628
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63703
Southeast Cancer Center
Cape Girardeau, Missouri, United States, 63703
Capital Region Medical Center-Goldschmidt Cancer Center
Jefferson City, Missouri, United States, 65109
Truman Medical Center
Kansas City, Missouri, United States, 64108
The University of Kansas Cancer Center-South
Kansas City, Missouri, United States, 64131
The University of Kansas Cancer Center-North
Kansas City, Missouri, United States, 64154
The University of Kansas Cancer Center-Lee's Summit
Lee's Summit, Missouri, United States, 64064
Phelps County Regional Medical Center
Rolla, Missouri, United States, 65401
Saint John's Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States, 65401
Saint Louis Cancer and Breast Institute-South City
Saint Louis, Missouri, United States, 63109
Missouri Baptist Medical Center
Saint Louis, Missouri, United States, 63131
Mercy Hospital Saint Louis
Saint Louis, Missouri, United States, 63141
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, United States, 63670
Cancer Research for the Ozarks NCORP
Springfield, Missouri, United States, 65804
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, United States, 63080
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri, United States, 63127
United States, Montana
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
Montana Cancer Consortium NCORP
Billings, Montana, United States, 59101
Saint Vincent Healthcare
Billings, Montana, United States, 59101
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States, 59701
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Saint Peter's Community Hospital
Helena, Montana, United States, 59601
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States, 59802
Community Medical Hospital
Missoula, Montana, United States, 59804
United States, Nevada
Cancer and Blood Specialists-Henderson
Henderson, Nevada, United States, 89052
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, United States, 89052
Las Vegas Cancer Center-Henderson
Henderson, Nevada, United States, 89052
21st Century Oncology - Henderson
Henderson, Nevada, United States, 89074
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, United States, 89074
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
Cancer and Blood Specialists-Shadow
Las Vegas, Nevada, United States, 89106
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States, 89106
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, United States, 89106
21st Century Oncology
Las Vegas, Nevada, United States, 89109
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Las Vegas, Nevada, United States, 89109
HealthCare Partners Medical Group Oncology/Hematology-San Martin
Las Vegas, Nevada, United States, 89113
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, United States, 89119
Cancer Therapy and Integrative Medicine
Las Vegas, Nevada, United States, 89121
Cancer and Blood Specialists-Tenaya
Las Vegas, Nevada, United States, 89128
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, United States, 89128
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Las Vegas, Nevada, United States, 89128
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, United States, 89144
Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada, United States, 89148-2405
21st Century Oncology - Fort Apache
Las Vegas, Nevada, United States, 89148
Cancer and Blood Specialists-Fort Apache
Las Vegas, Nevada, United States, 89148
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89148
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Las Vegas, Nevada, United States, 89149
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, United States, 89169
21st Century Oncology - Vegas Tenaya
Las Vegas, Nevada, United States, 89182
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87102
Christus Saint Vincent Regional Cancer Center
Santa Fe, New Mexico, United States, 87505
United States, New York
Columbia University/Herbert Irving Cancer Center
New York, New York, United States, 10032
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Cancer Care of Western North Carolina
Asheville, North Carolina, United States, 28801
Mission Hospital-Memorial Campus
Asheville, North Carolina, United States, 28801
Asheville Hematology-Oncology Associates
Asheville, North Carolina, United States, 28803
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, United States, 28328
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, United States, 27534
Wayne Memorial Hospital
Goldsboro, North Carolina, United States, 27534
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, United States, 28546
Iredell Memorial Hospital
Statesville, North Carolina, United States, 28677
Southeastern Medical Oncology Center-Wilson
Wilson, North Carolina, United States, 27893
Southeast Clinical Oncology Research (SCOR) Consortium NCORP
Winston-Salem, North Carolina, United States, 27104
United States, Ohio
Strecker Cancer Center-Belpre
Belpre, Ohio, United States, 45714
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Oncology Hematology Care Inc-Eden Park
Cincinnati, Ohio, United States, 45202
Oncology Hematology Care Inc-Mercy West
Cincinnati, Ohio, United States, 45211
Oncology Hematology Care Inc - Anderson
Cincinnati, Ohio, United States, 45230
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, United States, 45236
Oncology Hematology Care Inc-Blue Ash
Cincinnati, Ohio, United States, 45242
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, United States, 43214
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Columbus NCI Community Oncology Research Program
Columbus, Ohio, United States, 43215
Grant Medical Center
Columbus, Ohio, United States, 43215
The Mark H Zangmeister Center
Columbus, Ohio, United States, 43219
Mount Carmel Health Center West
Columbus, Ohio, United States, 43222
Doctors Hospital
Columbus, Ohio, United States, 43228
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States, 45406
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Samaritan North Health Center
Dayton, Ohio, United States, 45415
Dayton NCI Community Oncology Research Program
Dayton, Ohio, United States, 45420
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, United States, 43015
Delaware Radiation Oncology
Delaware, Ohio, United States, 43015
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Oncology Hematology Care Inc-Healthplex
Fairfield, Ohio, United States, 45014
Blanchard Valley Hospital
Findlay, Ohio, United States, 45840
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Wayne Hospital
Greenville, Ohio, United States, 45331
Kettering Medical Center
Kettering, Ohio, United States, 45429
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Knox Community Hospital
Mount Vernon, Ohio, United States, 43050
Licking Memorial Hospital
Newark, Ohio, United States, 43055
Newark Radiation Oncology
Newark, Ohio, United States, 43055
Southern Ohio Medical Center
Portsmouth, Ohio, United States, 45662
Springfield Regional Medical Center
Springfield, Ohio, United States, 45505
Upper Valley Medical Center
Troy, Ohio, United States, 45373
Saint Ann's Hospital
Westerville, Ohio, United States, 43081
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, United States, 43701
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States, 97015
Providence Milwaukie Hospital
Milwaukie, Oregon, United States, 97222
Providence Newberg Medical Center
Newberg, Oregon, United States, 97132
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States, 97045
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, South Carolina
Roper Hospital
Charleston, South Carolina, United States, 29401
Charleston Hematology Oncology Associates-Roper
Charleston, South Carolina, United States, 29403
Lowcountry Hematology Oncology PA-North Charleston
Charleston, South Carolina, United States, 29406
Charleston Hematology Oncology Associates PA-St. Francis
Charleston, South Carolina, United States, 29414
Lowcountry Hematology Oncology PA-West Ashley
Charleston, South Carolina, United States, 29414
Greenville Health System Cancer Institute-Easley
Easley, South Carolina, United States, 29640
Saint Francis Hospital
Greenville, South Carolina, United States, 29601
Greenville Health System Cancer Institute-Andrews
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Butternut
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, 29605
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, United States, 29615
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, United States, 29650
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States, 29651
Lowcountry Hematology Oncology PA-Mount Pleasant
Mount Pleasant, South Carolina, United States, 29464
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States, 29672
Spartanburg Medical Center
Spartanburg, South Carolina, United States, 29303
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States, 29307
United States, Tennessee
Wellmont Bristol Regional Medical Center
Bristol, Tennessee, United States, 37620
Wellmont Medical Associates Oncology and Hematology-Johnson City
Johnson City, Tennessee, United States, 37604
Wellmont Holston Valley Hospital and Medical Center
Kingsport, Tennessee, United States, 37660
Wellmont Medical Associates Oncology and Hematology-Kingsport
Kingsport, Tennessee, United States, 37660
United States, Texas
The Don and Sybil Harrington Cancer Center
Amarillo, Texas, United States, 79106
The Methodist Hospital System
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
United States, Virginia
Southwest VA Regional Cancer Center
Norton, Virginia, United States, 24273
United States, Washington
PeaceHealth Saint John Medical Center
Longview, Washington, United States, 98632
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122-4307
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States, 98664
United States, Wyoming
Rocky Mountain Oncology
Casper, Wyoming, United States, 82609
Big Horn Basin Cancer Center
Cody, Wyoming, United States, 82414
Billings Clinic-Cody
Cody, Wyoming, United States, 82414
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Richard Kim Southwest Oncology Group
  More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02042443     History of Changes
Other Study ID Numbers: NCI-2013-02485
NCI-2013-02485 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
S1310
SWOG-S1310
S1310 ( Other Identifier: SWOG )
S1310 ( Other Identifier: CTEP )
U10CA180888 ( U.S. NIH Grant/Contract )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: January 20, 2014
First Posted: January 22, 2014
Results First Submitted: July 12, 2017
Results First Posted: August 10, 2017
Last Update Posted: September 12, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Cholangiocarcinoma
Gallbladder Neoplasms
Bile Duct Neoplasms
Klatskin Tumor
Carcinoma, Ductal
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Biliary Tract Neoplasms
Biliary Tract Diseases
Gallbladder Diseases
Bile Duct Diseases
Neoplasms, Ductal, Lobular, and Medullary
Capecitabine
Fluorouracil
Trametinib
Calcium, Dietary
Leucovorin
Levoleucovorin
Folic Acid
Antimetabolites, Antineoplastic
Antimetabolites