AzTrials
AzTrials

Adult CholangiocarcinomaPhase 2S1310NCT02042443

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

A Phase 2 study testing Capecitabine, Fluorouracil and Laboratory Biomarker Analysis in people with Adult Cholangiocarcinoma and Advanced Adult Hepatocellular Carcinoma, run by National Cancer Institute (NCI) at 295 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?
Any age
What is being tested?
Capecitabine, Fluorouracil and Laboratory Biomarker Analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
295 sitesUnited States
Study dates
Feb 2014to 30 Apr 2017
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

None listed.

Trial locations and contacts

295 sites in 1 country.

295 sites in 1 country

United States295 sites

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

  • The Don and Sybil Harrington Cancer Center

    Amarillo, Texas, 79106

  • Kaiser Permanente-Anaheim

    Anaheim, California, 92807

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • Michigan Cancer Research Consortium NCORP

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Cancer Care of Western North Carolina

    Asheville, North Carolina, 28801

  • Mission Hospital-Memorial Campus

    Asheville, North Carolina, 28801

  • Asheville Hematology-Oncology Associates

    Asheville, North Carolina, 28803

  • Sutter Auburn Faith Hospital

    Auburn, California, 95602

  • University of Colorado Cancer Center - Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • Kaiser Permanente-Baldwin Park

    Baldwin Park, California, 91706

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • Kaiser Permanente-Bellflower

    Bellflower, California, 90706

  • Strecker Cancer Center-Belpre

    Belpre, Ohio, 45714

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Montana Cancer Consortium NCORP

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Parkland Health Center-Bonne Terre

    Bonne Terre, Missouri, 63628

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Wellmont Bristol Regional Medical Center

    Bristol, Tennessee, 37620

  • Mills - Peninsula Hospitals

    Burlingame, California, 94010

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Roper Hospital

    Charleston, South Carolina, 29401

  • Charleston Hematology Oncology Associates-Roper

    Charleston, South Carolina, 29403

  • Lowcountry Hematology Oncology PA-North Charleston

    Charleston, South Carolina, 29406

  • Charleston Hematology Oncology Associates PA-St. Francis

    Charleston, South Carolina, 29414

  • Lowcountry Hematology Oncology PA-West Ashley

    Charleston, South Carolina, 29414

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Oncology Hematology Care Inc-Eden Park

    Cincinnati, Ohio, 45202

  • Oncology Hematology Care Inc-Mercy West

    Cincinnati, Ohio, 45211

  • Oncology Hematology Care Inc - Anderson

    Cincinnati, Ohio, 45230

  • Oncology Hematology Care Inc-Kenwood

    Cincinnati, Ohio, 45236

  • Oncology Hematology Care Inc-Blue Ash

    Cincinnati, Ohio, 45242

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Southeastern Medical Oncology Center-Clinton

    Clinton, North Carolina, 28328

  • Big Horn Basin Cancer Center

    Cody, Wyoming, 82414

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

  • Kootenai Medical Center

    Coeur d'Alene, Idaho, 83814

  • Memorial Hospital Colorado Springs

    Colorado Springs, Colorado, 80909

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Columbus Oncology and Hematology Associates Inc

    Columbus, Ohio, 43214

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Columbus NCI Community Oncology Research Program

    Columbus, Ohio, 43215

  • Grant Medical Center

    Columbus, Ohio, 43215

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Doctors Hospital

    Columbus, Ohio, 43228

  • Oncology Hematology Care Inc-Crestview

    Crestview Hills, Kentucky, 41017

  • Sutter Davis Hospital

    Davis, California, 95616

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Health Center

    Dayton, Ohio, 45415

  • Dayton NCI Community Oncology Research Program

    Dayton, Ohio, 45420

  • Beaumont Hospital-Dearborn

    Dearborn, Michigan, 48124

  • Cancer Care Center of Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

  • Delaware Radiation Oncology

    Delaware, Ohio, 43015

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Smilow Cancer Hospital-Derby Care Center

    Derby, Connecticut, 06418

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Saint John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Greenville Health System Cancer Institute-Easley

    Easley, South Carolina, 29640

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Newman Regional Health

    Emporia, Kansas, 66801

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Oncology Hematology Care Inc-Healthplex

    Fairfield, Ohio, 45014

  • Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Hurley Medical Center

    Flint, Michigan, 48502

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Kaiser Permanente Hospital

    Fontana, California, 92335

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • University of Florida

    Gainesville, Florida, 32610

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • Saint Catherine Hospital

    Garden City, Kansas, 67846

  • Southeastern Medical Oncology Center-Goldsboro

    Goldsboro, North Carolina, 27534

  • Wayne Memorial Hospital

    Goldsboro, North Carolina, 27534

  • Mercy Health Saint Mary's

    Grand Rapids, Michigan, 49503

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Saint Rose Ambulatory and Surgery Center

    Great Bend, Kansas, 67530

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • Greenville Health System Cancer Institute-Andrews

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Butternut

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Faris

    Greenville, South Carolina, 29605

  • Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Eastside

    Greenville, South Carolina, 29615

  • Greenville Health System Cancer Institute-Greer

    Greer, South Carolina, 29650

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

  • Medical Oncology and Hematology Group PC-Guilford

    Guilford, Connecticut, 06437

  • Kaiser Permanente - Harbor City

    Harbor City, California, 90710

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

  • Hays Medical Center

    Hays, Kansas, 67601

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Cancer and Blood Specialists-Henderson

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada - Henderson

    Henderson, Nevada, 89052

  • Las Vegas Cancer Center-Henderson

    Henderson, Nevada, 89052

  • 21st Century Oncology - Henderson

    Henderson, Nevada, 89074

  • Comprehensive Cancer Centers of Nevada-Southeast Henderson

    Henderson, Nevada, 89074

  • The Methodist Hospital System

    Houston, Texas, 77030

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Kaiser Permanente-Irvine

    Irvine, California, 92618

  • Allegiance Health

    Jackson, Michigan, 49201

  • Southeastern Medical Oncology Center-Jacksonville

    Jacksonville, North Carolina, 28546

  • Capital Region Medical Center-Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

  • Wellmont Medical Associates Oncology and Hematology-Johnson City

    Johnson City, Tennessee, 37604

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • University of Kansas Cancer Center-West

    Kansas City, Kansas, 66112

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • Truman Medical Center

    Kansas City, Missouri, 64108

  • The University of Kansas Cancer Center-South

    Kansas City, Missouri, 64131

  • The University of Kansas Cancer Center-North

    Kansas City, Missouri, 64154

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • Wellmont Holston Valley Hospital and Medical Center

    Kingsport, Tennessee, 37660

  • Wellmont Medical Associates Oncology and Hematology-Kingsport

    Kingsport, Tennessee, 37660

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Cancer and Blood Specialists-Shadow

    Las Vegas, Nevada, 89106

  • Nevada Cancer Research Foundation CCOP

    Las Vegas, Nevada, 89106

  • Radiation Oncology Centers of Nevada Central

    Las Vegas, Nevada, 89106

  • 21st Century Oncology

    Las Vegas, Nevada, 89109

  • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

    Las Vegas, Nevada, 89109

  • HealthCare Partners Medical Group Oncology/Hematology-San Martin

    Las Vegas, Nevada, 89113

  • Radiation Oncology Centers of Nevada Southeast

    Las Vegas, Nevada, 89119

  • Cancer Therapy and Integrative Medicine

    Las Vegas, Nevada, 89121

  • Cancer and Blood Specialists-Tenaya

    Las Vegas, Nevada, 89128

  • Comprehensive Cancer Centers of Nevada - Northwest

    Las Vegas, Nevada, 89128

  • HealthCare Partners Medical Group Oncology/Hematology-Tenaya

    Las Vegas, Nevada, 89128

  • Comprehensive Cancer Centers of Nevada-Summerlin

    Las Vegas, Nevada, 89144

  • Las Vegas Cancer Center-Medical Center

    Las Vegas, Nevada, 89148-2405

  • 21st Century Oncology - Fort Apache

    Las Vegas, Nevada, 89148

  • Cancer and Blood Specialists-Fort Apache

    Las Vegas, Nevada, 89148

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148

  • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills

    Las Vegas, Nevada, 89149

  • Comprehensive Cancer Centers of Nevada - Central Valley

    Las Vegas, Nevada, 89169

  • 21st Century Oncology - Vegas Tenaya

    Las Vegas, Nevada, 89182

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

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

    Lee's Summit, Missouri, 64064

  • Cancer Center of Kansas-Liberal

    Liberal, Kansas, 67905

  • Saint Mary Mercy Hospital

    Livonia, Michigan, 48154

  • PeaceHealth Saint John Medical Center

    Longview, Washington, 98632

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Los Angeles County-USC Medical Center

    Los Angeles, California, 90033

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Kaiser Permanente-Cadillac

    Los Angeles, California, 90034

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Cancer Center of Kansas-Manhattan

    Manhattan, Kansas, 66502

  • Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Fremont - Rideout Cancer Center

    Marysville, California, 95901

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Cancer Center of Kansas - McPherson

    McPherson, Kansas, 67460

  • Providence Milwaukie Hospital

    Milwaukie, Oregon, 97222

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Community Medical Hospital

    Missoula, Montana, 59804

  • Memorial Medical Center

    Modesto, California, 95355

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Knox Community Hospital

    Mount Vernon, Ohio, 43050

  • Palo Alto Medical Foundation-Camino Division

    Mountain View, California, 94040

  • Palo Alto Medical Foundation-Gynecologic Oncology

    Mountain View, California, 94040

  • Lowcountry Hematology Oncology PA-Mount Pleasant

    Mt. Pleasant, South Carolina, 29464

  • Mercy Health Mercy Campus

    Muskegon, Michigan, 49444

  • Yale University

    New Haven, Connecticut, 06520

  • Columbia University/Herbert Irving Cancer Center

    New York, New York, 10032

  • Licking Memorial Hospital

    Newark, Ohio, 43055

  • Newark Radiation Oncology

    Newark, Ohio, 43055

  • Providence Newberg Medical Center

    Newberg, Oregon, 97132

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Lakeland Community Hospital

    Niles, Michigan, 49120

  • Yale-New Haven Hospital North Haven Medical Center

    North Haven, Connecticut, 06473

  • Southwest VA Regional Cancer Center

    Norton, Virginia, 24273

  • Sutter Cancer Research Consortium

    Novato, California, 94945

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Olathe Medical Center

    Olathe, Kansas, 66061

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Smilow Cancer Hospital-Orange Care Center

    Orange, Connecticut, 06477

  • Providence Willamette Falls Medical Center

    Oregon City, Oregon, 97045

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Radiation Oncology of Northern Illinois

    Ottawa, Illinois, 61350

  • University of Kansas Cancer Center-Overland Park

    Overland Park, Kansas, 66210

  • Palo Alto Medical Foundation Health Care

    Palo Alto, California, 94301

  • Kaiser Permanente - Panorama City

    Panorama City, California, 91402

  • Cancer Center of Kansas - Parsons

    Parsons, Kansas, 67357

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

  • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

    Pekin, Illinois, 61554

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61603

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • OSF Saint Francis Radiation Oncology at Peoria Cancer Center

    Peoria, Illinois, 61615

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

  • Valley Radiation Oncology

    Peru, Illinois, 61354

  • Via Christi Hospital-Pittsburg

    Pittsburg, Kansas, 66762

  • Saint Joseph Mercy Oakland

    Pontiac, Michigan, 48341

  • Lake Huron Medical Center

    Port Huron, Michigan, 48060

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Southern Ohio Medical Center

    Portsmouth, Ohio, 45662

  • Kootenai Cancer Center

    Post Falls, Idaho, 83854

  • Cancer Center of Kansas - Pratt

    Pratt, Kansas, 67124

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Spectrum Health Reed City Hospital

    Reed City, Michigan, 49677

  • Reid Health

    Richmond, Indiana, 47374

  • Kaiser Permanente-Riverside

    Riverside, California, 92505

  • University of Rochester

    Rochester, New York, 14642

  • Phelps County Regional Medical Center

    Rolla, Missouri, 65401

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

    Rolla, Missouri, 65401

  • Sutter Roseville Medical Center

    Roseville, California, 95661

  • Sutter General Hospital

    Sacramento, California, 95816

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Saint Mary's of Michigan

    Saginaw, Michigan, 48601

  • Lakeland Hospital

    Saint Joseph, Michigan, 49085

  • Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085

  • Sainte Genevieve County Memorial Hospital

    Sainte Genevieve, Missouri, 63670

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • Salina Regional Health Center

    Salina, Kansas, 67401

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • Kaiser Permanente-San Diego Mission

    San Diego, California, 92108

  • Kaiser Permanente-San Diego Zion

    San Diego, California, 92120

  • California Pacific Medical Center-Pacific Campus

    San Francisco, California, 94115

  • Kaiser Permanente-San Marcos

    San Marcos, California, 92069

  • Kootenai Cancer Clinic

    Sandpoint, Idaho, 83864

  • Palo Alto Medical Foundation-Santa Cruz

    Santa Cruz, California, 95065

  • Christus Saint Vincent Regional Cancer Center

    Santa Fe, New Mexico, 87505

  • Sutter Pacific Medical Foundation

    Santa Rosa, California, 95403

  • Swedish Medical Center-First Hill

    Seattle, Washington, 98122-4307

  • Greenville Health System Cancer Institute-Seneca

    Seneca, South Carolina, 29672

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Greenville Health System Cancer Institute-Spartanburg

    Spartanburg, South Carolina, 29307

  • Central Illinois Hematology Oncology Center

    Springfield, Illinois, 62702

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Springfield Clinic

    Springfield, Illinois, 62703

  • Memorial Medical Center

    Springfield, Illinois, 62781

  • Cancer Research for the Ozarks NCORP

    Springfield, Missouri, 65804

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Springfield Regional Medical Center

    Springfield, Ohio, 45505

  • Saint Louis Cancer and Breast Institute-South City

    St Louis, Missouri, 63109

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Iredell Memorial Hospital

    Statesville, North Carolina, 28677

  • Missouri Baptist Sullivan Hospital

    Sullivan, Missouri, 63080

  • Palo Alto Medical Foundation-Sunnyvale

    Sunnyvale, California, 94086

  • Missouri Baptist Outpatient Center-Sunset Hills

    Sunset Hills, Missouri, 63127

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Saint Francis Hospital and Medical Center - Topeka

    Topeka, Kansas, 66606

  • Charlotte Hungerford Hospital Center for Cancer Care

    Torrington, Connecticut, 06790

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Upper Valley Medical Center

    Troy, Ohio, 45373

  • Sutter Solano Medical Center/Cancer Center

    Vallejo, California, 94589

  • PeaceHealth Southwest Medical Center

    Vancouver, Washington, 98664

  • Saint John Macomb-Oakland Hospital

    Warren, Michigan, 48093

  • Smilow Cancer Hospital-Waterbury Care Center

    Waterbury, Connecticut, 06708

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Saint Ann's Hospital

    Westerville, Ohio, 43081

  • Associates In Womens Health

    Wichita, Kansas, 67208

  • Cancer Center of Kansas-Wichita Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas - Wichita

    Wichita, Kansas, 67214

  • Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wichita NCI Community Oncology Research Program

    Wichita, Kansas, 67214

  • Southeastern Medical Oncology Center-Wilson

    Wilson, North Carolina, 27893

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

  • Southeast Clinical Oncology Research (SCOR) Consortium NCORP

    Winston-Salem, North Carolina, 27104

  • Kaiser Permanente

    Woodland Hills, California, 91367

  • Genesis Healthcare System Cancer Care Center

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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:

  1. 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.

Being tested
Capecitabine, Fluorouracil, Laboratory Biomarker Analysis, Leucovorin Calcium, Trametinib
Medical subject headings
Cholangiocarcinoma, Klatskin Tumor, Carcinoma, Hepatocellular, Bile Duct Neoplasms, Gallbladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CapecitabineDrug

    Also called Ro 09-1978/000, Xeloda

    Given PO

  • FluorouracilDrug

    Also called 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-FU

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Leucovorin CalciumDrug

    Also called Adinepar, Calcifolin, Calcium (6S)-Folinate, Calcium Folinate

    Given IV

  • TrametinibDrug

    Also called GSK1120212, JTP-74057, MEK Inhibitor GSK1120212, Mekinist

    Given PO

Study groups in NCT02042443
Study groupRoleWhat they receive
TrametinibExperimentalPatients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Other: Laboratory Biomarker Analysis; Drug: Trametinib
ChemotherapyExperimentalPatients 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.
Receives: Drug: Capecitabine; Drug: Fluorouracil; Other: Laboratory Biomarker Analysis; Drug: Leucovorin Calcium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    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.

    Measured: Up to 2 years from registration

Secondary outcomes (3)

  1. Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug

    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.

    Measured: Up to 2 years

  2. Objective Response Rate

    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.

    Measured: Up to 2 years from registration

  3. Progression-free Survival

    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.

    Measured: Up to 2 years from registration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionJan 2017
  4. Study completion30 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02042443
Sponsor's protocol ID
NCI-2013-02485
Other IDs
NCI-2013-02485, S1310, SWOG-S1310, S1310, S1310, U10CA180888, U10CA032102
Acronym
S1310
Status last verified
Aug 2017
First submitted
20 Jan 2014
Last updated
12 Sep 2017
Data monitoring committee
No

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