Whole-Brain Radiation Therapy or Stereotactic Radiosurgery with or without Lapatinib Ditosylate in Treating Patients with Brain Metastasis from HER2-Positive Breast Cancer

Status: Active

Description

This randomized phase II trial studies how well whole-brain radiation therapy or stereotactic radiosurgery with or without lapatinib ditosylate works in treating patients with breast cancer that has too many of a protein called human epidermal growth factor receptor 2 (HER2) on its cells and has spread to the brain. Radiation therapy uses high energy x rays to kill tumor cells and shrink tumors. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether whole-brain radiation therapy or stereotactic radiosurgery together with lapatinib ditosylate is an effective treatment for brain metastasis from breast cancer.

Eligibility Criteria

Inclusion Criteria

  • Pathologically (histologically or cytologically) proven diagnosis of invasive breast cancer
  • HER2-overexpressing breast cancer (3+ staining by immunohistochemistry or HER2 gene amplification by fluorescent in situ hybridization [FISH] or silver in situ hybridization [SISH] >= 2.0)
  • At least 1 measurable unirradiated parenchymal brain metastasis within 21 days prior to study entry; patients who are to undergo SRS must have no more than 10 brain metastases; there is no limit on number of brain metastases for WBRT; the minimum size as measured on T1-weighted gadolinium-enhanced MRI must be as follows according to the number of brain metastases: * For a single solitary lesion the size must be >= 10 mm * For 2 or more lesions, the size of at least 2 of the lesions must be >= 5 mm * Patients may also have the following provided the size requirements above are met: ** Progressive parenchymal brain metastasis following stereotactic radiosurgery for 1-3 brain metastases, with at least 1 new measurable brain lesion ** Progressive parenchymal brain metastasis following surgical resection of 1-3 brain metastases, with at least 1 measurable brain lesion
  • History/physical examination within 21 days prior to study entry
  • Karnofsky performance status >= 60 within 21 days prior to study entry
  • Able to swallow and retain oral medication (note: for patients unable to swallow tablets, an oral suspension preparation is acceptable)
  • Absolute neutrophil count (ANC) >= 1,200 cells/mm^3 (within 21 days prior to study entry)
  • Platelets >= 70,000 cells/mm^3 (within 21 days prior to study entry)
  • Hemoglobin >= 8.0 g/dL (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dL is acceptable) (within 21 days prior to study entry)
  • Creatinine < 1.5 times institutional upper limit of normal (within 21 days prior to study entry)
  • Bilirubin < 1.5 times institutional upper limit of normal (within 21 days prior to study entry)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 times institutional upper limit of normal with or without liver metastasis (within 21 days prior to study entry)
  • Patient must provide study specific informed consent prior to study entry
  • Women of childbearing potential must have a negative serum pregnancy test within 21 days prior to study entry
  • Sexually active women of childbearing potential and sexually active men must practice adequate contraception during therapy and for 12 months after protocol treatment completion
  • Prior lapatinib is allowed as long as the last dose received was > 21 days prior to study entry and provided the patient has not received it at any time after the diagnosis of brain metastasis

Exclusion Criteria

  • Prior WBRT
  • Prior radiation therapy (RT) (any site) with concurrent lapatinib defined as 1 or more days on which the patient received both radiation therapy and lapatinib on the same day
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Prior invasive malignancy (except non-melanomatous skin cancer, curatively resected thyroid papillary carcinoma, and invasive and non-invasive cancers related to the breast cancer) unless disease free for a minimum of 3 years
  • Leptomeningeal disease
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields except patients who have progressed following stereotactic radiosurgery for 1-3 brain metastases, with at least one new lesion
  • Severe, active co-morbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months * Transmural myocardial infarction within the last 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study entry * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; hepatic or biliary disease that is acute or currently active or that requires antiviral therapy (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per investigator assessment) * History of left ventricular ejection fraction (LVEF) below institutional normal unless repeated and within institutional normal range within 90 days of study entry
  • Grade 2 or greater rash of any cause at time of study entry
  • Grade 2 or greater diarrhea of any cause at time of study entry

Locations & Contacts

Arizona

Phoenix
Saint Joseph's Hospital and Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 877-602-4111

California

Carmichael
Mercy San Juan Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 916-556-3301
Email: OncologyResearch@DignityHealth.org
Dublin
Epic Care-Dublin
Status: Active
Contact: Site Public Contact
Phone: 925-875-1677
Emeryville
Bay Area Breast Surgeons Inc
Status: Active
Contact: Site Public Contact
Phone: 510-835-9900
Epic Care Partners in Cancer Care
Status: Active
Contact: Site Public Contact
Phone: 510-629-6682
Martinez
Contra Costa Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 925-957-5400
Oakland
Alta Bates Summit Medical Center - Summit Campus
Status: Active
Contact: Site Public Contact
Phone: 510-204-1414
Bay Area Tumor Institute
Status: Active
Contact: Site Public Contact
Phone: 510-465-2242
Email: lradke@bati.org
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 650-498-7061
Email: ccto-office@stanford.edu
Sacramento
Mercy General Hospital Radiation Oncology Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 916-453-4528
Walnut Creek
Epic Care Cyberknife Center
Status: Active
Contact: Site Public Contact
Phone: 510-465-8016
Email: somega@bati.org

Connecticut

Hartford
Smilow Cancer Hospital Care Center at Saint Francis
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 203-785-5702
Email: canceranswers@yale.edu

Delaware

Lewes
Beebe Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 302-645-3770
Email: Dmiskin@Beebehealthcare.org
Newark
Christiana Care Health System-Christiana Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Delaware Clinical and Laboratory Physicians PA
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Helen F Graham Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Medical Oncology Hematology Consultants PA
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Regional Hematology and Oncology PA
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Rehoboth Beach
Beebe Health Campus
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 302-645-3100
Email: Dmiskin@Beebehealthcare.org
Seaford
Nanticoke Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 302-645-3100
Email: Dmiskin@Beebehealthcare.org
Wilmington
Christiana Care Health System-Wilmington Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org

Florida

Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 305-243-2647
Miami
Miami Cancer Institute
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 786-596-2000
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 305-243-2647

Georgia

Cumming
Northside Hospital-Forsyth
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 404-303-3355
Email: clinicaltrials@northside.com
Fayetteville
Piedmont Fayette Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org
Gainesville
Northeast Georgia Medical Center-Gainesville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 770-219-8800
Email: cancerpatient.navigator@nghs.com
Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: Active
Contact: Site Public Contact
Phone: 912-819-5704
Email: underberga@sjchs.org

Illinois

Aurora
Rush - Copley Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 630-978-6212
Email: Cancer.Research@rushcopley.com
Chicago
John H Stroger Jr Hospital of Cook County
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 312-864-5204
Presence Saint Joseph Hospital-Chicago
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 773-665-3109
Danville
Carle on Vermilion
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Effingham
Carle Physician Group-Effingham
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Mount Vernon
Good Samaritan Regional Health Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 618-242-4600
Urbana
Carle Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com

Indiana

Fort Wayne
Radiation Oncology Associates PC
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 877-437-2408
Mishawaka
Memorial Regional Cancer Center Day Road
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
South Bend
Memorial Hospital of South Bend
Status: Active
Contact: Site Public Contact
Phone: 800-284-7370
Michiana Hematology Oncology PC-South Bend
Status: Temporarily closed to accrual
Contact: Binh Nguyen Tran
Phone: 574-237-1328

Iowa

Cedar Rapids
Saint Luke's Hospital
Status: Active
Contact: Site Public Contact
Phone: 319-368-5514
Email: Rachel.varner@unitypoint.org

Kansas

Garden City
Central Care Cancer Center - Garden City
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 913-948-5588
Email: aroland@kccop.org
Great Bend
Central Care Cancer Center - Great Bend
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 913-948-5588
Email: aroland@kccop.org
Lenexa
Kansas Institute of Medicine Cancer and Blood Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 913-948-5588
Email: aroland@kccop.org
Minimally Invasive Surgery Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 913-948-5588
Email: aroland@kccop.org
Overland Park
Menorah Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 913-948-5588
Email: aroland@kccop.org

Maryland

Baltimore
Greater Baltimore Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 443-849-3706

Massachusetts

Boston
Boston Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 617-638-8265

Michigan

Adrian
Bixby Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 517-265-0116
Hickman Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 517-265-0116
Ann Arbor
Saint Joseph Mercy Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
University of Michigan Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-865-1125
Battle Creek
Bronson Battle Creek
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Big Rapids
Spectrum Health Big Rapids Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 616-456-8115
Brighton
Saint Joseph Mercy Brighton
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Brownstown
Henry Ford Cancer Institute-Downriver
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Canton
Saint Joseph Mercy Canton
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Chelsea
Saint Joseph Mercy Chelsea
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Clinton Township
Henry Ford Macomb Hospital-Clinton Township
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Dearborn
Beaumont Hospital – Dearborn
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 248-551-7695
Detroit
Ascension Saint John Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Henry Ford Hospital
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Flint
Genesys Hurley Cancer Institute
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Hurley Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Grand Rapids
Mercy Health Saint Mary's
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Spectrum Health at Butterworth Campus
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Iron Mountain
Green Bay Oncology - Iron Mountain
Status: Temporarily closed to accrual
Contact: James L. Leenstra
Phone: 855-776-0015
Jackson
Allegiance Health
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Kalamazoo
Borgess Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Bronson Methodist Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
West Michigan Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Lansing
Sparrow Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Livonia
Saint Mary Mercy Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Monroe
Mercy Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-240-5400
Toledo Clinic Cancer Centers-Monroe
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-444-3561
Muskegon
Mercy Health Mercy Campus
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Niles
Lakeland Hospital Niles
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Pontiac
21st Century Oncology-Pontiac
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Joseph Mercy Oakland
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Port Huron
Lake Huron Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Saginaw
Ascension Saint Mary's Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Joseph
Lakeland Medical Center Saint Joseph
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Marie Yeager Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Traverse City
Munson Medical Center
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Warren
Saint John Macomb-Oakland Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
West Bloomfield
Henry Ford West Bloomfield Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Wyoming
Metro Health Hospital
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org

Minnesota

Burnsville
Fairview Ridges Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Coon Rapids
Mercy Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Edina
Fairview-Southdale Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Fridley
Unity Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Maple Grove
Fairview Maple Grove Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Maplewood
Minnesota Oncology Hematology PA-Maplewood
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Saint John's Hospital - Healtheast
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Minneapolis
Abbott-Northwestern Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Health Partners Inc
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Hennepin County Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Robbinsdale
North Memorial Medical Health Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Saint Paul
Regions Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
United Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Waconia
Ridgeview Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Willmar
Rice Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com

Mississippi

Pascagoula
Singing River Hospital
Status: Active
Contact: Site Public Contact
Phone: 228-809-5292

Missouri

Bolivar
Central Care Cancer Center - Bolivar
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 913-948-5588
Email: aroland@kccop.org
Cape Girardeau
Saint Francis Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Creve Coeur
Siteman Cancer Center at West County Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Independence
Centerpoint Medical Center LLC
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 913-948-5588
Email: aroland@kccop.org
Joplin
Mercy Hospital Joplin
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 417-556-3074
Email: esmeralda.carrillo@mercy.net
Kansas City
Heartland Hematology and Oncology Associates Incorporated
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 913-948-5588
Email: aroland@kccop.org
North Kansas City Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 816-691-1599
Research Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 913-948-5588
Email: aroland@kccop.org
Liberty
Liberty Radiation Oncology Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 913-948-5588
Email: aroland@kccop.org
Rolla
Delbert Day Cancer Institute at PCRMC
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 573-458-7504
Email: jrichards@research.pcrmc.com
Mercy Clinic-Rolla-Cancer and Hematology
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 573-458-7504
Email: jrichards@research.pcrmc.com
Saint Joseph
Heartland Regional Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 816-271-7937
Email: linda.schumacher@mymlc.com
Saint Joseph Oncology Inc
Status: Temporarily closed to accrual
Contact: Rakesh Gaur
Phone: 913-948-5588
Email: aroland@kccop.org
Saint Louis
Mercy Hospital Saint Louis
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 314-251-7066
Saint Louis Cancer and Breast Institute-South City
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 314-353-1870
Siteman Cancer Center-South County
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Washington University School of Medicine
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Springfield
CoxHealth South Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 417-269-4520
Mercy Hospital Springfield
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 417-269-4520

New Hampshire

Manchester
Elliot Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 603-663-1800

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 505-925-0366
Email: LByatt@nmcca.org
Las Cruces
Memorial Medical Center - Las Cruces
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 575-556-6545
Email: Kim.Hoffman@lpnt.net

New York

Bronx
Montefiore Medical Center - Moses Campus
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 718-379-6866
Email: aaraiza@montefiore.org
Brooklyn
New York-Presbyterian / Brooklyn Methodist Hospital
Status: Active
Contact: Site Public Contact
Phone: 718-780-3677
Email: Adg9003@nyp.org
Buffalo
Roswell Park Cancer Institute
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-767-9355
Email: askroswell@roswellpark.org
Rochester
Highland Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 585-341-8113
University of Rochester
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 585-275-5830

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-668-0683
Email: cancerclinicaltrials@med.unc.edu
Hendersonville
AdventHealth Hendersonville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 828-650-8037
Email: Heather.M.Duncan@AdventHealth.com
Statesville
Iredell Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 704-873-5661

Ohio

Beachwood
Cleveland Clinic Cancer Center Beachwood
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
UHHS-Chagrin Highlands Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Bowling Green
Toledo Clinic Cancer Centers-Bowling Green
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
Canton
Mercy Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-293-4673
Chardon
Geauga Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Cleveland
Case Western Reserve University
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Cleveland Clinic Cancer Center / Fairview Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Cleveland Clinic Foundation
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-293-5066
Email: Jamesline@osumc.edu
Elyria
Mercy Cancer Center-Elyria
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Independence
Cleveland Clinic Cancer Center Independence
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Lima
Lima Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
Mansfield
Cleveland Clinic Cancer Center Mansfield
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Maumee
Toledo Clinic Cancer Centers-Maumee
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-444-3561
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 419-891-5600ext4
Mayfield Heights
Hillcrest Hospital Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Mentor
UH Seidman Cancer Center at Lake Health Mentor Campus
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Middleburg Heights
UH Seidman Cancer Center at Southwest General Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Oregon
Saint Charles Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 419-696-7200
Toledo Clinic Cancer Centers-Oregon
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
Parma
University Hospitals Parma Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Ravenna
University Hospitals Portage Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Salem
UH Seidman Cancer Center at Salem Regional Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Sandusky
North Coast Cancer Care
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Strongsville
Cleveland Clinic Cancer Center Strongsville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Sylvania
ProMedica Flower Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 419-824-1842
Tiffin
Mercy Hospital of Tiffin
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
Toledo
Mercy Saint Anne Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 419-407-1160
Saint Vincent Mercy Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 419-251-4919
Toledo Clinic Cancer Centers-Toledo
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-444-3561
Toledo Community Hospital Oncology Program CCOP
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: info@tcop.info
University of Toledo
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 419-383-6583
Wauseon
Fulton County Health Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 419-330-2708
Westlake
UHHS-Westlake Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Wooster
Cancer Treatment Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 330-375-4221
Cleveland Clinic Wooster Family Health and Surgery Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org

Oklahoma

Tulsa
Natalie Warren Bryant Cancer Center at Saint Francis
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 918-494-2200
Warren Clinic Oncology-Tulsa
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com

Oregon

Gresham
Legacy Mount Hood Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 503-413-2150
Portland
Legacy Good Samaritan Hospital and Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-220-4937
Email: cancer@lhs.org

Pennsylvania

Allentown
Lehigh Valley Hospital-Cedar Crest
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Bethlehem
Lehigh Valley Hospital - Muhlenberg
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
East Stroudsburg
Pocono Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 570-422-1700
Email: ann.foster@lvhn.org
Philadelphia
Thomas Jefferson University Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 215-955-6084
West Reading
Reading Hospital
Status: Active
Contact: Site Public Contact
Phone: 610-988-9323

South Carolina

Anderson
AnMed Health Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 864-512-4651
Email: rhonda.ballew@anmedhealth.org
Gaffney
Gibbs Cancer Center-Gaffney
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 864-560-6104
Email: kmertz-rivera@gibbscc.org
Greer
Gibbs Cancer Center-Pelham
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 864-560-6104
Email: kmertz-rivera@gibbscc.org
Spartanburg
Spartanburg Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 864-560-6104
Email: kmertz-rivera@gibbscc.org

Texas

Lubbock
Covenant Medical Center-Lakeside
Status: Active
Contact: Site Public Contact
Phone: 806-725-8000
Email: jaccresearch@covhs.org

Vermont

Berlin
Central Vermont Medical Center / National Life Cancer Treatment
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 802-225-5400
Burlington
University of Vermont and State Agricultural College
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 802-656-8990
Email: rpo@uvm.edu
University of Vermont Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 802-656-4101
Email: rpo@uvm.edu

Virginia

Fredericksburg
Fredericksburg Oncology Inc
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 804-628-1939
Email: mwellons@vcu.edu

Washington

Vancouver
Legacy Salmon Creek Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 503-413-2150

Wisconsin

Green Bay
Green Bay Oncology at Saint Vincent Hospital
Status: Temporarily closed to accrual
Contact: Eva N. Christensen
Phone: 920-433-8889
Green Bay Oncology Limited at Saint Mary's Hospital
Status: Active
Contact: Eva N. Christensen
Phone: 920-433-8889
Saint Vincent Hospital Cancer Center at Saint Mary's
Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org
Saint Vincent Hospital Cancer Center Green Bay
Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org
Johnson Creek
UW Cancer Center Johnson Creek
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 920-699-3500
Email: lynda.persico@uwmf.wisc.edu
Madison
University of Wisconsin Hospital and Clinics
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-622-8922
Manitowoc
Holy Family Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 920-320-2749
Milwaukee
Froedtert and the Medical College of Wisconsin
Status: Active
Contact: Site Public Contact
Phone: 414-805-4380
New Richmond
Cancer Center of Western Wisconsin
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Oconto Falls
Saint Vincent Hospital Cancer Center at Oconto Falls
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org
Sturgeon Bay
Green Bay Oncology - Sturgeon Bay
Status: Active
Contact: Eva N. Christensen
Phone: 920-433-8889
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org

Quebec

Montreal
Jewish General Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 514-340-8222ext8248

Korea, Republic of

Goyang-si
National Cancer Center-Korea
Status: Active
Contact: Site Public Contact
Phone: 82-31-920-1934
Hwasun-gun
Chonnam National University Hwasun Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: (82) 061-379-7900
Jung-Ku
Keimyung University-Dongsan Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: ho@dsmc.or.kr
Seongnam City
Seoul National University Bundang Hospital
Status: Active
Contact: Site Public Contact
Phone: 82-2-2072-2890
Seoul
Gangnam Severance Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 82-2-2019-3600
Samsung Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 011-82-1599-3114
Seoul National University Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 011-82-760-2384
Yonsei University Health System-Severance Hospital
Status: Active
Contact: Site Public Contact
Email: ihcc@yuhs.ac

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine if there is a signal for an increase in complete response (CR) rate in the measurable brain metastases at 12 weeks post radiation therapy (RT) (whole brain or stereotactic radiosurgery [SRS]) as determined by magnetic-resonance imaging (MRI) scan of the brain, with the addition of lapatinib (lapatinib ditosylate) to whole-brain radiation therapy (WBRT)/SRS compared to WBRT/SRS alone.

SECONDARY OBJECTIVES:

I. To evaluate CR rate of the measurable brain metastases at 4 weeks post RT (WBRT/SRS) as determined by MRI scan of the brain, with the addition of lapatinib to WBRT/SRS compared to WBRT/SRS alone.

II. To evaluate objective response rate of measurable brain metastases at 4 and 12 weeks post RT (WBRT/SRS) as determined by MRI scan of the brain, with the addition of lapatinib to WBRT/SRS compared to WBRT/SRS alone.

III. To evaluate targeted lesion-specific objective response rate (CR + partial response [PR]) at 4 and 12 weeks post WBRT/SRS.

IV. To evaluate central nervous system (CNS) progressive disease outside the targeted measurable disease with addition of lapatinib to WBRT/SRS compared to WBRT/SRS alone.

V. To evaluate targeted lesion-specific progression at 4 and 12 weeks post WBRT/SRS.

VI. To evaluate treatment related adverse events when adding lapatinib to WBRT/SRS compared to WBRT/SRS alone.

VII. To evaluate overall CNS complete response: disappearance of all CNS target lesions sustained for at least 4 weeks; with no new lesions, no use of corticosteroids, and patient is stable or improved clinically, when adding lapatinib to WBRT/SRS compared to WBRT/SRS alone.

VIII. To evaluate overall CNS progressive disease (within or outside targeted measurable disease) with addition of lapatinib to WBRT/SRS compared to WBRT/SRS alone.

IX. To evaluate overall survival when adding lapatinib to WBRT/SRS compared to WBRT/SRS alone.

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

ARM A: Patients undergo WBRT 5 days a week for 3 weeks for a total of 15 treatments or SRS for 1 treatment.

ARM B: Patients undergo WBRT or SRS as in Arm A. Patients also receive lapatinib ditosylate orally (PO) once daily (QD) for 6 weeks.

After completion of study treatment, patients are followed up at 4 and 12 weeks and then every 12 weeks thereafter.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
NRG Oncology

Principal Investigator
In Ah Kim

Trial IDs

Primary ID RTOG-1119
Secondary IDs NCI-2012-01977, CDR0000735353
Clinicaltrials.gov ID NCT01622868