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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02926638
Other study ID # S1400E
Secondary ID NCI-2014-01382S1
Status Terminated
Phase Phase 2/Phase 3
First received
Last updated
Start date June 16, 2014
Est. completion date October 12, 2016

Study information

Verified date March 2020
Source Southwest Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized phase II/III compares rilotumumab when given together with erlotinib hydrochloride against erlotinib hydrochloride alone in treating patients with stage IV squamous cell lung cancer that has come back after previous treatment. This is a sub-study that includes all screened patients positive for the met proto-oncogene (MET)/hepatocyte growth factor (HGF) biomarker. HGF can interact with MET and can cause tumor cells to grow more quickly. Rilotumumab may decrease the activity of HGF and may be able to shrink tumors. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving rilotumumab with erlotinib hydrochloride works better than erlotinib hydrochloride alone (standard treatment) in treating squamous cell lung cancer.


Description:

PRIMARY OBJECTIVES:

I. To evaluate if there is sufficient evidence to continue to the phase III component of S1400E by comparing investigator-assessed progression-free survival (IA-PFS) between rilotumumab plus erlotinib versus erlotinib in patients registered to S1400E. (Phase II) II. To determine if there is both a statistically and clinically-meaningful difference in IA-PFS between patients randomized to receive rilotumumab plus erlotinib versus erlotinib. (Phase III) III. To compare overall survival (OS) in patients randomized to rilotumumab plus erlotinib versus erlotinib. (Phase III)

SECONDARY OBJECTIVES:

I. To compare response rates (confirmed and unconfirmed, complete and partial responses) among patients randomized to receive rilotumumab plus erlotinib versus erlotinib. (Phase II) II. To evaluate the frequency and severity of toxicities associated with rilotumumab plus erlotinib versus erlotinib. (Phase II) III. To compare the response rates (confirmed and unconfirmed, complete and partial) among patients randomized to receive rilotumumab plus erlotinib versus erlotinib. (Phase III) IV. To evaluate the frequency and severity of toxicities associated with rilotumumab plus erlotinib versus erlotinib. (Phase III)

TERTIARY OBJECTIVES:

I. To evaluate the treatment arm randomization acceptance rate within each treatment arm of S1400E defined as the percentage of patients randomized to a treatment arm that receive any protocol treatment.

II. To identify additional predictive or prognostic tumor/blood biomarkers beyond the chosen biomarker.

III. To identify potential resistance biomarkers at disease progression. IV. To establish a tissue/blood repository from patients with refractory squamous cell cancer.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I (CLOSED TO ACCRUAL AND INTERVENTION11/25/2014): Patients receive rilotumumab intravenously (IV) over 60-120 minutes on day 1 and erlotinib hydrochloride orally (PO) daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II (CLOSED TO ACCRUAL AND INTERVENTION11/25/2014): Patients receive erlotinib hydrochloride PO daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, all patients will be followed until death or 3 years after sub-study registration, whichever occurs first.


Recruitment information / eligibility

Status Terminated
Enrollment 9
Est. completion date October 12, 2016
Est. primary completion date January 12, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)

- Patients must be assigned to S1400E; S1400E biomarker eligibility defined as C-MET positive is defined as follows:

- Analyte: C-MET

- Assay: Immunohistochemistry (IHC)

- Eligible definition: IHC positive based on Dako MET-IHC pharm DX kit

- If randomized to arm I rilotumumab plus erlotinib, patients must be willing to provide blood specimens for anti-rilotumumab anti-body testing

- Patients must not have peripheral edema > grade 1 at the time of sub-study registration

- Patients must not have received prior treatment with MET pathway, inhibitors or EGFR inhibitors (e.g., erlotinib)

- Patients must have total bilirubin =< 1.5 x institutional upper limits of normal (IULN) within 28 days prior to sub-study registration

- Patients must not have abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjorgren?s syndrome), congenital abnormality (e.g., Fuch?s dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal-Rose), and/or abnormal corneal sensitivity test (Schirmer test or similar tear production test)

- Patients must not be taking, nor plan to take while on protocol treatment and for 14 days post the last dose of study treatment, drugs, herbal supplements or foods that are known to be strong/moderate CYP3A4 substrates

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Erlotinib Hydrochloride
Given PO
Other:
Laboratory Biomarker Analysis
Correlative studies
Biological:
Rilotumumab
Given IV

Locations

Country Name City State
United States Hawaii Oncology Inc-Pali Momi 'Aiea Hawaii
United States Pali Momi Medical Center 'Aiea Hawaii
United States The Cancer Center of Hawaii-Leeward 'Ewa Beach Hawaii
United States Bixby Medical Center Adrian Michigan
United States Hickman Cancer Center Adrian Michigan
United States Phoebe Putney Memorial Hospital Albany Georgia
United States The Don and Sybil Harrington Cancer Center Amarillo Texas
United States Mary Greeley Medical Center Ames Iowa
United States McFarland Clinic PC-William R Bliss Cancer Center Ames Iowa
United States Kaiser Permanente-Anaheim Anaheim California
United States AnMed Health Cancer Center Anderson South Carolina
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Langlade Hospital and Cancer Center Antigo Wisconsin
United States Kaiser Permanente-Deer Valley Medical Center Antioch California
United States Fox Valley Hematology and Oncology SC-Appleton Appleton Wisconsin
United States Cancer Care of Western North Carolina Asheville North Carolina
United States Mission Hospital-Memorial Campus Asheville North Carolina
United States Emory University Hospital Midtown Atlanta Georgia
United States Emory University/Winship Cancer Institute Atlanta Georgia
United States Northside Hospital Atlanta Georgia
United States Piedmont Hospital Atlanta Georgia
United States MultiCare Auburn Medical Center Auburn Washington
United States Sutter Auburn Faith Hospital Auburn California
United States Harold Alfond Center for Cancer Care Augusta Maine
United States Rocky Mountain Cancer Centers-Aurora Aurora Colorado
United States Rush - Copley Medical Center Aurora Illinois
United States The Medical Center of Aurora Aurora Colorado
United States Dell Seton Medical Center at The University of Texas Austin Texas
United States Kaiser Permanente-Baldwin Park Baldwin Park California
United States MedStar Franklin Square Medical Center/Weinberg Cancer Institute Baltimore Maryland
United States MedStar Union Memorial Hospital Baltimore Maryland
United States Sinai Hospital of Baltimore Baltimore Maryland
United States Eastern Maine Medical Center Bangor Maine
United States Boston Baskin Cancer Center-Bartlett Bartlett Tennessee
United States Hematology/Oncology Clinic LLP Baton Rouge Louisiana
United States Mary Bird Perkins Cancer Center Baton Rouge Louisiana
United States Ochsner Health Center-Summa Baton Rouge Louisiana
United States Cleveland Clinic Cancer Center Beachwood Beachwood Ohio
United States UPMC-Heritage Valley Health System Beaver Beaver Pennsylvania
United States Overlake Hospital Medical Center Bellevue Washington
United States Kaiser Permanente-Bellflower Bellflower California
United States PeaceHealth Saint Joseph Medical Center Bellingham Washington
United States Strecker Cancer Center-Belpre Belpre Ohio
United States Sanford Clinic North-Bemidgi Bemidji Minnesota
United States Saint Charles Health System Bend Oregon
United States Alta Bates Summit Medical Center-Herrick Campus Berkeley California
United States Central Vermont Medical Center/National Life Cancer Treatment Berlin Vermont
United States Beverly Hospital Beverly Massachusetts
United States Billings Clinic Cancer Center Billings Montana
United States Montana Cancer Consortium NCORP Billings Montana
United States Saint Vincent Healthcare Billings Montana
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Joseph Medical Center Bloomington Illinois
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Central Care Cancer Center-Carrie J Babb Cancer Center Bolivar Missouri
United States Parkland Health Center-Bonne Terre Bonne Terre Missouri
United States McFarland Clinic PC-Boone Boone Iowa
United States Boulder Community Hospital Boulder Colorado
United States Rocky Mountain Cancer Centers-Boulder Boulder Colorado
United States Toledo Clinic Cancer Centers-Bowling Green Bowling Green Ohio
United States Bozeman Deaconess Hospital Bozeman Montana
United States CoxHealth Cancer Center Branson Missouri
United States Montefiore Medical Center - Moses Campus Bronx New York
United States Montefiore Medical Center-Einstein Campus Bronx New York
United States Montefiore Medical Center-Weiler Hospital Bronx New York
United States Mills-Peninsula Medical Center Burlingame California
United States Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin
United States Lahey Hospital and Medical Center Burlington Massachusetts
United States University of Vermont College of Medicine Burlington Vermont
United States Fairview Ridges Hospital Burnsville Minnesota
United States Saint James Community Hospital and Cancer Treatment Center Butte Montana
United States Aultman Health Foundation Canton Ohio
United States Illinois CancerCare-Canton Canton Illinois
United States Mercy Medical Center Canton Ohio
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Cancer Center Cape Girardeau Missouri
United States Illinois CancerCare-Carthage Carthage Illinois
United States Rocky Mountain Oncology Casper Wyoming
United States Centralia Oncology Clinic Centralia Illinois
United States Providence Regional Cancer System-Centralia Centralia Washington
United States Christiana Care Health System-Concord Health Center Chadds Ford Pennsylvania
United States Charleston Hematology Oncology Associates PA-St. Francis Charleston South Carolina
United States Charleston Hematology Oncology Associates-Roper Charleston South Carolina
United States Lowcountry Hematology Oncology PA-North Charleston Charleston South Carolina
United States Lowcountry Hematology Oncology PA-West Ashley Charleston South Carolina
United States Medical University of South Carolina Charleston South Carolina
United States Roper Hospital Charleston South Carolina
United States West Virginia University Charleston Charleston West Virginia
United States Novant Health Presbyterian Medical Center Charlotte North Carolina
United States Oncology Specialists of Charlotte Charlotte North Carolina
United States Southern Oncology Specialists-Charlotte Charlotte North Carolina
United States Saint Luke's Hospital Chesterfield Missouri
United States Cheyenne Regional Medical Center-West Cheyenne Wyoming
United States Mount Sinai Hospital Medical Center Chicago Illinois
United States Swedish Covenant Hospital Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin
United States Oncology Hematology Care Inc - Anderson Cincinnati Ohio
United States Oncology Hematology Care Inc-Blue Ash Cincinnati Ohio
United States Oncology Hematology Care Inc-Eden Park Cincinnati Ohio
United States Oncology Hematology Care Inc-Kenwood Cincinnati Ohio
United States Oncology Hematology Care Inc-Mercy West Cincinnati Ohio
United States Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado
United States University of Missouri - Ellis Fischel Columbia Missouri
United States Baptist Cancer Center-Golden Triangle Columbus Mississippi
United States Columbus NCI Community Oncology Research Program Columbus Ohio
United States Columbus Oncology and Hematology Associates Inc Columbus Ohio
United States Doctors Hospital Columbus Ohio
United States Grant Medical Center Columbus Ohio
United States Mount Carmel Health Center West Columbus Ohio
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States The Mark H Zangmeister Center Columbus Ohio
United States Cookeville Regional Medical Center Cookeville Tennessee
United States Mercy Hospital Coon Rapids Minnesota
United States Baptist Health Corbin Corbin Kentucky
United States Oncology Hematology Care Inc-Crestview Crestview Hills Kentucky
United States Siteman Cancer Center at West County Hospital Creve Coeur Missouri
United States Northside Hospital-Forsyth Cumming Georgia
United States Carle on Vermilion Danville Illinois
United States Genesis Medical Center - East Campus Davenport Iowa
United States Sutter Davis Hospital Davis California
United States Dayton NCI Community Oncology Research Program Dayton Ohio
United States Good Samaritan Hospital - Dayton Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Samaritan North Health Center Dayton Ohio
United States Beaumont Hospital-Dearborn Dearborn Michigan
United States Cancer Care Center of Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach Florida
United States Delaware Health Center-Grady Cancer Center Delaware Ohio
United States Delaware Radiation Oncology Delaware Ohio
United States Grady Memorial Hospital Delaware Ohio
United States Colorado Blood Cancer Institute Denver Colorado
United States Colorado Cancer Research Program NCORP Denver Colorado
United States Porter Adventist Hospital Denver Colorado
United States Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado
United States Rocky Mountain Cancer Centers-Midtown Denver Colorado
United States Rocky Mountain Cancer Centers-Rose Denver Colorado
United States Rose Medical Center Denver Colorado
United States SCL Health Saint Joseph Hospital Denver Colorado
United States Smilow Cancer Hospital-Derby Care Center Derby Connecticut
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Iowa-Wide Oncology Research Coalition NCORP Des Moines Iowa
United States Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa
United States Henry Ford Hospital Detroit Michigan
United States Saint John Hospital and Medical Center Detroit Michigan
United States Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States City of Hope Comprehensive Cancer Center Duarte California
United States Mercy Medical Center Durango Colorado
United States Greenville Health System Cancer Institute-Easley Easley South Carolina
United States Veterans Adminstration New Jersey Health Care System East Orange New Jersey
United States Marshfield Clinic Cancer Center at Sacred Heart Eau Claire Wisconsin
United States Sacred Heart Hospital Eau Claire Wisconsin
United States Fairview-Southdale Hospital Edina Minnesota
United States Carle Physician Group-Effingham Effingham Illinois
United States Crossroads Cancer Center Effingham Illinois
United States Advocate Sherman Hospital Elgin Illinois
United States Hardin Memorial Hospital Elizabethtown Kentucky
United States Michiana Hematology Oncology PC-Elkhart Elkhart Indiana
United States Arnot Ogden Medical Center/Falck Cancer Center Elmira New York
United States Comprehensive Cancer Care and Research Institute of Colorado LLC Englewood Colorado
United States Swedish Medical Center Englewood Colorado
United States Ephrata Cancer Center Ephrata Pennsylvania
United States Ephrata Community Hospital Ephrata Pennsylvania
United States Illinois CancerCare-Eureka Eureka Illinois
United States NorthShore University HealthSystem-Evanston Hospital Evanston Illinois
United States Saint Francis Hospital Evanston Illinois
United States Providence Regional Cancer Partnership Everett Washington
United States Oncology Hematology Care Inc-Healthplex Fairfield Ohio
United States Roger Maris Cancer Center Fargo North Dakota
United States Sanford Broadway Medical Center Fargo North Dakota
United States Sanford Clinic North-Fargo Fargo North Dakota
United States Weisberg Cancer Treatment Center Farmington Hills Michigan
United States Blanchard Valley Hospital Findlay Ohio
United States IU Health Central Indiana Cancer Centers-Fishers Fishers Indiana
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Kaiser Permanente Hospital Fontana California
United States McFarland Clinic PC-Trinity Cancer Center Fort Dodge Iowa
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Fredericksburg Oncology Inc Fredericksburg Virginia
United States Hematology Oncology Associates of Fredericksburg Inc Fredericksburg Virginia
United States Kaiser Permanente-Fremont Fremont California
United States Washington Hospital Fremont California
United States Kaiser Permanente Fresno California
United States Unity Hospital Fridley Minnesota
United States Saint Jude Medical Center Fullerton California
United States University of Florida Health Science Center ?? Gainesville Gainesville Florida
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States Georgetown Hospital System Georgetown South Carolina
United States Aurora Health Care Germantown Health Center Germantown Wisconsin
United States Adams Cancer Center Gettysburg Pennsylvania
United States NorthShore University HealthSystem-Glenbrook Hospital Glenview Illinois
United States Addison Gilbert Hospital Gloucester Massachusetts
United States Mountain Blue Cancer Care Center Golden Colorado
United States National Jewish Health-Western Hematology Oncology Golden Colorado
United States Wayne Memorial Hospital Goldsboro North Carolina
United States Aurora Cancer Care-Grafton Grafton Wisconsin
United States Benefis Healthcare- Sletten Cancer Institute Great Falls Montana
United States North Colorado Medical Center Greeley Colorado
United States Aurora BayCare Medical Center Green Bay Wisconsin
United States UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg Pennsylvania
United States Greenville Health System Cancer Institute-Andrews Greenville South Carolina
United States Greenville Health System Cancer Institute-Butternut Greenville South Carolina
United States Greenville Health System Cancer Institute-Eastside Greenville South Carolina
United States Greenville Health System Cancer Institute-Faris Greenville South Carolina
United States Greenville Memorial Hospital Greenville South Carolina
United States Saint Francis Hospital Greenville South Carolina
United States Wayne Hospital Greenville Ohio
United States Rocky Mountain Cancer Centers-Greenwood Village Greenwood Village Colorado
United States Gibbs Cancer Center-Pelham Greer South Carolina
United States Boston Baskin Cancer Center-Grenada Grenada Mississippi
United States Medical Oncology and Hematology Group PC-Guilford Guilford Connecticut
United States Cherry Tree Cancer Center Hanover Pennsylvania
United States Kaiser Permanente - Harbor City Harbor City California
United States PinnacleHealth Cancer Center-Community Campus Harrisburg Pennsylvania
United States Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut
United States Saint Peter's Community Hospital Helena Montana
United States 21st Century Oncology - Henderson Henderson Nevada
United States Cancer and Blood Specialists-Henderson Henderson Nevada
United States Comprehensive Cancer Centers of Nevada - Henderson Henderson Nevada
United States Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson Nevada
United States Las Vegas Cancer Center-Henderson Henderson Nevada
United States Hendersonville Hematology and Oncology at Pardee Hendersonville North Carolina
United States Margaret R Pardee Memorial Hospital Hendersonville North Carolina
United States Park Ridge Hospital Breast Health Center Hendersonville North Carolina
United States Penn State Milton S Hershey Medical Center Hershey Pennsylvania
United States NorthShore University HealthSystem-Highland Park Hospital Highland Park Illinois
United States Hawaii Cancer Care Inc-Liliha Honolulu Hawaii
United States Hawaii Cancer Care Inc-POB II Honolulu Hawaii
United States Hawaii Oncology Inc-Kuakini Honolulu Hawaii
United States Kaiser Permanente Moanalua Medical Center Honolulu Hawaii
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Kuakini Medical Center Honolulu Hawaii
United States Queen's Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital Honolulu Hawaii
United States The Cancer Center of Hawaii-Liliha Honolulu Hawaii
United States University of Hawaii Cancer Center Honolulu Hawaii
United States M D Anderson Cancer Center Houston Texas
United States The Methodist Hospital System Houston Texas
United States Lake Norman Hematology Oncology Specialists-Huntersville Huntersville North Carolina
United States Southern Oncology Specialists-Huntersville Huntersville North Carolina
United States Hutchinson Area Health Care Hutchinson Minnesota
United States Centerpoint Medical Center LLC Independence Missouri
United States Cleveland Clinic Cancer Center Independence Independence Ohio
United States Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana
United States IU Health Central Indiana Cancer Centers-East Indianapolis Indiana
United States Sidney and Lois Eskenazi Hospital Indianapolis Indiana
United States Springmill Medical Center Indianapolis Indiana
United States Kaiser Permanente-Irvine Irvine California
United States Allegiance Health Jackson Michigan
United States McFarland Clinic PC-Jefferson Jefferson Iowa
United States Capital Region Medical Center-Goldschmidt Cancer Center Jefferson City Missouri
United States UPMC-Johnstown/John P. Murtha Regional Cancer Center Johnstown Pennsylvania
United States Fowler Family Center for Cancer Care Jonesboro Arkansas
United States Freeman Health System Joplin Missouri
United States Mercy Hospital-Joplin Joplin Missouri
United States West Michigan Cancer Center Kalamazoo Michigan
United States Kalispell Regional Medical Center Kalispell Montana
United States Presence Saint Mary's Hospital Kankakee Illinois
United States Heartland Hematology and Oncology Associates Incorporated Kansas City Missouri
United States Research Medical Center Kansas City Missouri
United States Saint Luke's Hospital of Kansas City Kansas City Missouri
United States CHI Health Good Samaritan Kearney Nebraska
United States Ochsner Medical Center Kenner Kenner Louisiana
United States Aurora Cancer Care-Kenosha South Kenosha Wisconsin
United States Kettering Medical Center Kettering Ohio
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Kinston Medical Specialists PA Kinston North Carolina
United States UC San Diego Moores Cancer Center La Jolla California
United States Marshfield Clinic - Ladysmith Center Ladysmith Wisconsin
United States IU Health Arnett Cancer Care Lafayette Indiana
United States Rocky Mountain Cancer Centers-Lakewood Lakewood Colorado
United States Saint Anthony Hospital Lakewood Colorado
United States Carolina Blood and Cancer Care Associates PA-Lancaster Lancaster South Carolina
United States City of Hope Antelope Valley Lancaster California
United States Fairfield Medical Center Lancaster Ohio
United States Lancaster Radiation Oncology Lancaster Ohio
United States Sparrow Hospital Lansing Michigan
United States 21st Century Oncology Las Vegas Nevada
United States 21st Century Oncology - Fort Apache Las Vegas Nevada
United States 21st Century Oncology - Vegas Tenaya Las Vegas Nevada
United States Cancer and Blood Specialists-Shadow Las Vegas Nevada
United States Cancer and Blood Specialists-Tenaya Las Vegas Nevada
United States Cancer Therapy and Integrative Medicine Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Northwest Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-San Martin Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Tenaya Las Vegas Nevada
United States Las Vegas Cancer Center-Medical Center Las Vegas Nevada
United States Nevada Cancer Research Foundation CCOP Las Vegas Nevada
United States Nevada Cancer Specialists-Fort Apache Las Vegas Nevada
United States Radiation Oncology Centers of Nevada Central Las Vegas Nevada
United States Radiation Oncology Centers of Nevada Southeast Las Vegas Nevada
United States Summerlin Hospital Medical Center Las Vegas Nevada
United States Cancer Centers of Southwest Oklahoma Research Lawton Oklahoma
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States Saint Luke's East - Lee's Summit Lee's Summit Missouri
United States Beebe Medical Center Lewes Delaware
United States Saint Joseph Regional Medical Center Lewiston Idaho
United States Baptist Health Lexington Lexington Kentucky
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States Liberty Radiation Oncology Center Liberty Missouri
United States Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii
United States Lima Memorial Hospital Lima Ohio
United States Nebraska Cancer Research Center Lincoln Nebraska
United States Nebraska Hematology and Oncology Lincoln Nebraska
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Littleton Adventist Hospital Littleton Colorado
United States Rocky Mountain Cancer Centers-Littleton Littleton Colorado
United States Saint Mary Mercy Hospital Livonia Michigan
United States Loma Linda University Medical Center Loma Linda California
United States Rocky Mountain Cancer Centers-Sky Ridge Lone Tree Colorado
United States Sky Ridge Medical Center Lone Tree Colorado
United States Longmont United Hospital Longmont Colorado
United States Rocky Mountain Cancer Centers-Longmont Longmont Colorado
United States Kaiser Permanente Los Angeles Medical Center Los Angeles California
United States Kaiser Permanente-Cadillac Los Angeles California
United States Los Angeles County-USC Medical Center Los Angeles California
United States USC / Norris Comprehensive Cancer Center Los Angeles California
United States The James Graham Brown Cancer Center at University of Louisville Louisville Kentucky
United States McKee Medical Center Loveland Colorado
United States Covenant Medical Center-Lakeside Lubbock Texas
United States Lynchburg Hematology-Oncology Clinic Lynchburg Virginia
United States Illinois CancerCare-Macomb Macomb Illinois
United States Baptist Health Madisonville/Merle Mahr Cancer Center Madisonville Kentucky
United States Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
United States Saint John's Hospital - Healtheast Maplewood Minnesota
United States Marietta Memorial Hospital Marietta Ohio
United States Vince Lombardi Cancer Clinic-Marinette Marinette Wisconsin
United States McFarland Clinic PC-Marshalltown Marshalltown Iowa
United States Marshfield Clinic Marshfield Wisconsin
United States Marshfield Medical Center Marshfield Wisconsin
United States Mercy Medical Center - North Iowa Mason City Iowa
United States Matthews Radiation Oncology Center Matthews North Carolina
United States Novant Health Cancer Specialists-Matthews Matthews North Carolina
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Toledo Clinic Cancer Centers-Maumee Maumee Ohio
United States Toledo Radiation Oncology at Northwest Ohio Onocolgy Center Maumee Ohio
United States Hillcrest Hospital Cancer Center Mayfield Heights Ohio
United States Loyola University Medical Center Maywood Illinois
United States UPMC Cancer Center at UPMC McKeesport McKeesport Pennsylvania
United States Baptist Memorial Hospital and Cancer Center-Memphis Memphis Tennessee
United States Baptist Memorial Hospital for Women Memphis Tennessee
United States Family Cancer Center-Memphis Memphis Tennessee
United States Robert Veith MD LLC Metairie Louisiana
United States University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
United States Franciscan Saint Anthony Health-Michigan City Michigan City Indiana
United States Woodland Cancer Care Center Michigan City Indiana
United States Mid-Michigan Medical Center - Midland Midland Michigan
United States Aurora Cancer Care-Milwaukee Milwaukee Wisconsin
United States Aurora Saint Luke's Medical Center Milwaukee Wisconsin
United States Aurora Sinai Medical Center Milwaukee Wisconsin
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Health Partners Inc Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Trinity Cancer Care Center Minot North Dakota
United States Memorial Regional Cancer Center Day Road Mishawaka Indiana
United States Michiana Hematology Oncology PC-Mishawaka Mishawaka Indiana
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States Kaiser Permanente-Modesto Modesto California
United States Memorial Medical Center Modesto California
United States Mercy Memorial Hospital Monroe Michigan
United States Toledo Clinic Cancer Centers-Monroe Monroe Michigan
United States UPMC-Coraopolis/Heritage Valley Radiation Oncology Moon Pennsylvania
United States Lake Norman Hematology Oncology Specialists-Mooresville Mooresville North Carolina
United States Virtua Memorial Mount Holly New Jersey
United States Lowcountry Hematology Oncology PA-Mount Pleasant Mount Pleasant South Carolina
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Knox Community Hospital Mount Vernon Ohio
United States Palo Alto Medical Foundation-Camino Division Mountain View California
United States Palo Alto Medical Foundation-Gynecologic Oncology Mountain View California
United States Hematology Oncology Consultants Limited Naperville Illinois
United States Smilow Cancer Center/Yale-New Haven Hospital New Haven Connecticut
United States Yale University New Haven Connecticut
United States Yale-New Haven Hospital Saint Raphael Campus New Haven Connecticut
United States Louisiana State University Health Science Center New Orleans Louisiana
United States LSU Healthcare Network/Saint Charles New Orleans Louisiana
United States Ochsner Medical Center Jefferson New Orleans Louisiana
United States Tulane University Health Sciences Center New Orleans Louisiana
United States University Medical Center New Orleans New Orleans Louisiana
United States Cancer Center of Western Wisconsin New Richmond Wisconsin
United States New Ulm Medical Center New Ulm Minnesota
United States Columbia University/Herbert Irving Cancer Center New York New York
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States Christiana Gynecologic Oncology LLC Newark Delaware
United States Delaware Clinical and Laboratory Physicians PA Newark Delaware
United States Helen F Graham Cancer Center Newark Delaware
United States Licking Memorial Hospital Newark Ohio
United States Medical Oncology Hematology Consultants PA Newark Delaware
United States Newark Radiation Oncology Newark Ohio
United States Regional Hematology and Oncology PA Newark Delaware
United States Faith Regional Medical Offices West Norfolk Nebraska
United States Community Cancer Center Foundation Normal Illinois
United States Yale-New Haven Hospital North Haven Medical Center North Haven Connecticut
United States Eastern Connecticut Hematology and Oncology Associates Norwich Connecticut
United States Sutter Cancer Research Consortium Novato California
United States Kaiser Permanente-Oakland Oakland California
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Capital Medical Center Olympia Washington
United States Providence - Saint Peter Hospital Olympia Washington
United States Alegent Health Bergan Mercy Medical Center Omaha Nebraska
United States Alegent Health Immanuel Medical Center Omaha Nebraska
United States Alegent Health Lakeside Hospital Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Missouri Valley Cancer Consortium Omaha Nebraska
United States Oncology Hematology West Omaha Nebraska
United States Saint Joseph Hospital - Orange Orange California
United States Smilow Cancer Hospital-Orange Care Center Orange Connecticut
United States Saint Charles Hospital Oregon Ohio
United States Toledo Clinic Cancer Centers-Oregon Oregon Ohio
United States Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Radiation Oncology of Northern Illinois Ottawa Illinois
United States Menorah Medical Center Overland Park Kansas
United States Saint Luke's South Hospital Overland Park Kansas
United States Family Cancer Center-Oxford Oxford Mississippi
United States Kaiser Permanente - Panorama City Panorama City California
United States Feather River Cancer Center Paradise California
United States Parker Adventist Hospital Parker Colorado
United States Rocky Mountain Cancer Centers-Parker Parker Colorado
United States Illinois CancerCare-Pekin Pekin Illinois
United States OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Pekin Illinois
United States Sacred Heart Hospital Pensacola Florida
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States OSF Saint Francis Medical Center Peoria Illinois
United States OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States FirstHealth of the Carolinas-Moore Regional Hosiptal Pinehurst North Carolina
United States University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania
United States UPMC Jefferson Regional Radiation Oncology Pittsburgh Pennsylvania
United States UPMC-Magee Womens Hospital Pittsburgh Pennsylvania
United States UPMC-Passavant Hospital Pittsburgh Pennsylvania
United States UPMC-Presbyterian Hospital Pittsburgh Pennsylvania
United States UPMC-Saint Clair Hospital Cancer Center Pittsburgh Pennsylvania
United States UPMC-Saint Margaret Pittsburgh Pennsylvania
United States UPMC-Shadyside Hospital Pittsburgh Pennsylvania
United States Michiana Hematology Oncology PC-Plymouth Plymouth Indiana
United States Saint Joseph Mercy Oakland Pontiac Michigan
United States Lake Huron Medical Center Port Huron Michigan
United States Kaiser Permanente Northwest Portland Oregon
United States Mercy Hospital Portland Maine
United States Southern Ohio Medical Center Portsmouth Ohio
United States Kootenai Cancer Center Post Falls Idaho
United States Illinois CancerCare-Princeton Princeton Illinois
United States Rocky Mountain Cancer Centers - Pueblo Pueblo Colorado
United States Saint Mary Corwin Medical Center Pueblo Colorado
United States MultiCare Good Samaritan Hospital Puyallup Washington
United States Aurora Cancer Care-Racine Racine Wisconsin
United States Eisenhower Medical Center Rancho Mirage California
United States Northwest Hospital Center Randallstown Maryland
United States Rapid City Regional Hospital Rapid City South Dakota
United States Kaiser Permanente-Redwood City Redwood City California
United States Beebe Health Campus Rehoboth Beach Delaware
United States Alpine Hematology-Oncology Reno Nevada
United States Radiation Oncology Associates Reno Nevada
United States Reno Oncology Consultants Reno Nevada
United States Renown Regional Medical Center Reno Nevada
United States Saint Mary's Regional Medical Center Reno Nevada
United States Marshfield Clinic at James Beck Cancer Center Rhinelander Wisconsin
United States Saint Mary's Hospital Rhinelander Wisconsin
United States Lakeview Medical Center-Marshfield Clinic Rice Lake Wisconsin
United States Marshfield Clinic-Rice Lake Center Rice Lake Wisconsin
United States Kaiser Permanente-Richmond Richmond California
United States Reid Health Richmond Indiana
United States Virginia Cancer Institute Richmond Virginia
United States Virginia Commonwealth University/Massey Cancer Center Richmond Virginia
United States Kaiser Permanente-Riverside Riverside California
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Highland Hospital Rochester New York
United States University of Rochester Rochester New York
United States Penobscot Bay Medical Center Rockport Maine
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Saint John's Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States Kaiser Permanente-Roseville Roseville California
United States Sutter Roseville Medical Center Roseville California
United States William Beaumont Hospital-Royal Oak Royal Oak Michigan
United States Kaiser Permanente - Sacramento Sacramento California
United States Kaiser Permanente-South Sacramento Sacramento California
United States Sutter Medical Center Sacramento Sacramento California
United States University of California Davis Comprehensive Cancer Center Sacramento California
United States Saint Mary's of Michigan Saginaw Michigan
United States Saint Helena Hospital Saint Helena California
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Metro Minnesota Community Oncology Research Consortium Saint Louis Park Minnesota
United States Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States Regions Hospital Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Siteman Cancer Center at Saint Peters Hospital Saint Peters Missouri
United States Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah
United States Kaiser Permanente-San Diego Mission San Diego California
United States Kaiser Permanente-San Diego Zion San Diego California
United States California Pacific Medical Center-Pacific Campus San Francisco California
United States Kaiser Permanente-San Francisco San Francisco California
United States Kaiser Permanente-Santa Teresa-San Jose San Jose California
United States Kaiser Permanente San Leandro San Leandro California
United States Kaiser Permanente-San Marcos San Marcos California
United States Kaiser Permanente-San Rafael San Rafael California
United States North Coast Cancer Care Sandusky Ohio
United States Kaiser Permanente Medical Center - Santa Clara Santa Clara California
United States Kaiser Permanente-Santa Rosa Santa Rosa California
United States Sutter Pacific Medical Foundation Santa Rosa California
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Memorial University Medical Center Savannah Georgia
United States Guthrie Medical Group PC-Robert Packer Hospital Sayre Pennsylvania
United States Regional West Medical Center Scottsbluff Nebraska
United States Nanticoke Memorial Hospital Seaford Delaware
United States Greenville Health System Cancer Institute-Seneca Seneca South Carolina
United States UPMC Cancer Center at UPMC Northwest Seneca Pennsylvania
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin
United States Welch Cancer Center Sheridan Wyoming
United States Siouxland Regional Cancer Center Sioux City Iowa
United States Sanford Cancer Center-Oncology Clinic Sioux Falls South Dakota
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States North Shore Medical Center Skokie Illinois
United States Memorial Hospital of South Bend South Bend Indiana
United States Michiana Hematology Oncology PC-South Bend South Bend Indiana
United States Northern Indiana Cancer Research Consortium South Bend Indiana
United States VCU Community Memorial Health Center South Hill Virginia
United States City of Hope South Pasadena South Pasadena California
United States Kaiser Permanente-South San Francisco South San Francisco California
United States Family Cancer Center-Southhaven Southaven Mississippi
United States Providence Hospital-Southfield Cancer Center Southfield Michigan
United States Baptist Memorial Hospital-Desoto Southhaven Mississippi
United States Greenville Health System Cancer Institute-Spartanburg Spartanburg South Carolina
United States Spartanburg Medical Center Spartanburg South Carolina
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Springfield Regional Medical Center Springfield Ohio
United States Baptist Cancer Institute-Starkville Starkville Mississippi
United States Marshfield Clinic Cancer Care at Saint Michael's Hospital Stevens Point Wisconsin
United States Saint Michael's Hospital Stevens Point Wisconsin
United States Lakeview Hospital Stillwater Minnesota
United States Kaiser Permanente-Stockton Stockton California
United States Cleveland Clinic Cancer Center Strongsville Strongsville Ohio
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States Aurora Medical Center in Summit Summit Wisconsin
United States Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri
United States Flower Hospital Sylvania Ohio
United States MultiCare Allenmore Hospital Tacoma Washington
United States MultiCare Tacoma General Hospital Tacoma Washington
United States Northwest Medical Specialties PLLC Tacoma Washington
United States Northwest NCI Community Oncology Research Program Tacoma Washington
United States Saint Joseph Medical Center Tacoma Washington
United States Moffitt Cancer Center Tampa Florida
United States Rocky Mountain Cancer Centers-Thornton Thornton Colorado
United States Mercy Hospital of Tiffin Tiffin Ohio
United States Mercy Saint Anne Hospital Toledo Ohio
United States Saint Vincent Mercy Medical Center Toledo Ohio
United States Toledo Clinic Cancer Centers-Toledo Toledo Ohio
United States Toledo Community Hospital Oncology Program CCOP Toledo Ohio
United States University of Toledo Toledo Ohio
United States Cotton O'Neil Cancer Center / Stormont Vail Health Topeka Kansas
United States Charlotte Hungerford Hospital Center for Cancer Care Torrington Connecticut
United States Upper Valley Medical Center Troy Ohio
United States William Beaumont Hospital - Troy Troy Michigan
United States Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa Oklahoma
United States Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin
United States UPMC Uniontown Hospital Radiation Oncology Uniontown Pennsylvania
United States Carle Cancer Center Urbana Illinois
United States The Carle Foundation Hospital Urbana Illinois
United States Kaiser Permanente Medical Center-Vacaville Vacaville California
United States South Georgia Medical Center/Pearlman Cancer Center Valdosta Georgia
United States Kaiser Permanente-Vallejo Vallejo California
United States Sutter Solano Medical Center/Cancer Center Vallejo California
United States Virtua Voorhees Voorhees New Jersey
United States Ridgeview Medical Center Waconia Minnesota
United States Kaiser Permanente-Walnut Creek Walnut Creek California
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Northwestern Medicine Cancer Center Warrenville Warrenville Illinois
United States MedStar Georgetown University Hospital Washington District of Columbia
United States UPMC Washington Hospital Radiation Oncology Washington Pennsylvania
United States Smilow Cancer Hospital-Waterbury Care Center Waterbury Connecticut
United States Covenant Medical Center Waterloo Iowa
United States Aurora Cancer Care-Waukesha Waukesha Wisconsin
United States Aspirus Regional Cancer Center Wausau Wisconsin
United States Marshfield Clinic-Wausau Center Wausau Wisconsin
United States Fulton County Health Center Wauseon Ohio
United States Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin
United States Aurora West Allis Medical Center West Allis Wisconsin
United States Chester County Hospital West Chester Pennsylvania
United States Methodist West Hospital West Des Moines Iowa
United States Reading Hospital West Reading Pennsylvania
United States Saint Ann's Hospital Westerville Ohio
United States Diagnostic and Treatment Center Weston Wisconsin
United States Marshfield Clinic - Weston Center Weston Wisconsin
United States Saint Clare's Hospital Weston Wisconsin
United States Michiana Hematology Oncology PC-Westville Westville Indiana
United States SCL Health Lutheran Medical Center Wheat Ridge Colorado
United States UPMC Susquehanna Williamsport Pennsylvania
United States Rice Memorial Hospital Willmar Minnesota
United States Christiana Care Health System-Wilmington Hospital Wilmington Delaware
United States Shenandoah Oncology Associates PC Winchester Virginia
United States Southeast Clinical Oncology Research (SCOR) Consortium NCORP Winston-Salem North Carolina
United States Wake Forest University Health Sciences Winston-Salem North Carolina
United States Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Kaiser Permanente Woodland Hills California
United States Cleveland Clinic Wooster Family Health and Surgery Center Wooster Ohio
United States WellSpan Health-York Cancer Center York Pennsylvania
United States WellSpan Health-York Hospital York Pennsylvania
United States York Hospital York Maine
United States Rush-Copley Healthcare Center Yorkville Illinois
United States Genesis Healthcare System Cancer Care Center Zanesville Ohio

Sponsors (2)

Lead Sponsor Collaborator
Southwest Oncology Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Treatment Arm Randomization Acceptance Rate Monitored by the percentage of patients that receive at least one dose of the treatment they are randomized to. Up to 3 years
Primary Investigator-assessed Progression-free Survival Between Arms A stratified (using randomization stratification factors) log-rank test will be used to test the primary hypotheses related to investigator-assessed progression-free survival, comparing the two treatment arms. From date of sub-study registration to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause, assessed up to 18 months since completion of accrual
Primary Objective Response Rate (Confirmed and Unconfirmed, Complete and Partial) Between Arms Up to 3 years
Secondary Frequency and Severity of Toxicities Associated With Investigational Therapy Versus Standard of Care Up to 3 years
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