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Randomized Phase II Trial of Capecitabine and Lapatinib With or Without IMC-A12 in Patients With HER2 Positive Breast Cancer Previously Treated With Trastuzumab and an Anthracycline and/or a Taxane


Phase 2
18 Years
N/A
Open (Enrolling)
Both
HER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer

Thank you

Trial Information

Randomized Phase II Trial of Capecitabine and Lapatinib With or Without IMC-A12 in Patients With HER2 Positive Breast Cancer Previously Treated With Trastuzumab and an Anthracycline and/or a Taxane


PRIMARY OBJECTIVES:

I. To compare progression-free survival of HER2+ breast cancer patients randomized to
receive lapatinib and capecitabine +/- IMC-A12.

SECONDARY OBJECTIVES:

I. To assess the safety and tolerability of lapatinib and capecitabine +/- IMC-A12 in HER2+
breast cancer patients.

II. To compare the overall survival time, time to treatment failure, confirmed tumor
response rate, and duration of response of lapatinib and capecitabine +/- IMC-A12 in HER2+
breast cancer patients.

III. To assess patient compliance per treatment arm and to compare overall quality of life
and treatment side effects via patient-reported outcomes between treatment arms.

TERTIARY OBJECTIVES:

I. To determine the role of the following in predicting response to lapatinib and
capecitabine +/- IMC-A12:

II. Expression patterns and/or activation IGF- and ErbB family of receptors and signaling
molecules in formalin-fixed, paraffin-embedded breast tumor tissue.

III. Expression patterns and/or activation IGF- and ErbB receptors and signaling molecules
in circulating tumor cells from breast cancer patients.

IV. Changes in expression patterns and/or activation IGF- and ErbB receptors and signaling
molecules following treatment with lapatinib and capecitabine +/- IMC-A12 in circulating
tumor cells from breast cancer patients.

V. Expression patterns of IGF-1, IGF-II, insulin, growth hormone, and the IGF binding
proteins in the serum of breast cancer patients.

VI. Changes in expression patterns of IGF-1, IGF-II, insulin, growth hormone, and the IGF
binding proteins in the serum of breast cancer patients.

VII. As part of ongoing research for NCCTG breast studies, we are banking paraffin-embedded
tissue blocks/slides and blood products (i.e., serum, plasma, and buffy coat) for future
studies.

VIII. To assess the proportion of patients whose pathologic specimens were correctly
diagnosed as HER2 positive (according to 2007 ASCO CAP guidelines) metastatic breast cancer.

OUTLINE: This is a multicenter study. Patients are stratified according to hormone receptor
status (estrogen receptor- or progesterone receptor-positive vs other) and number of prior
chemotherapy regimens in the metastatic setting (2 vs 1 vs none). The first 10 patients
enrolled on this study are assigned to cohort 1 (safety analysis). All other patients are
assigned to cohort 2 (randomized treatment).

COHORT 1 (SAFETY ANALYSIS): Patients receive cixutumumab IV over 1-1½ hours on days 1, 8,
and 15. Patients also receive oral capecitabine twice daily on days 1-14 and oral lapatinib
ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease
progression or unacceptable toxicity.

COHORT 2 (RANDOMIZED TREATMENT): Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib
ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease
progression or unacceptable toxicity.

ARM II: Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also
receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in
the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline and on day 8 of courses 1 and 2 for biomarker
laboratory studies. Serum and circulating tumor cell biomarkers are analyzed by
immunohistochemistry or immunofluorescence for changes in protein expression (total and
phosphorylated). Tumor tissue samples obtained at the time of original diagnosis are
analyzed by immunohistochemistry for protein biomarkers.

Patients complete quality of life questionnaires periodically. After completion of study
treatment, patients are followed every 3 months until disease progression and then every 6
months for up to 5 years.


Inclusion Criteria:



- Histologically confirmed breast cancer, meeting one of the following criteria:

- Locally advanced disease (i.e., stage IIIB or IIIC [T4 primary tumor] disease)

- Metastatic disease

- Disease progressed after treatment with regimens that included trastuzumab
(Herceptin®) in combination with an anthracycline and/or a taxane

- Must have received 1-2 prior chemotherapy regimens in the neoadjuvant, adjuvant,
or metastatic setting

- One regimen must have included treatment with an anthracyclineand/or a
taxane

- Prior treatment with trastuzumab required unless there is a contraindication for
trastuzumab treatment

- HER2-positive disease, defined by any of the following:

- Validated IHC assay score of 3+ (defined as uniform, intensestaining of > 30% of
invasive tumor cells)

- Average HER2 gene copy number > 6

- Gene amplified (HER2:D17Z1 ratio > 2.20)

- Measurable disease according to RECIST criteria

- No evidence of active brain metastases, including leptomeningeal involvement

- CNSmetastasis controlled* by prior surgery and/or radiotherapy is allowed

- Hormone receptor status not specified

- Menopausal status not specified

- ECOG performance status 0-2

- Life expectancy > 3 months

- WBC ≥ 3,000/mm³

- ANC ≥ 1,500/mm³

- Platelet count ≥ 75,000/mm³

- Hemoglobin > 9.0 g/dL

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST and ALT ≤ 2.5 times ULN (5 times ULN if elevations are due to liver metastases)

- Serum creatinine ≤ 1.5 times ULN

- Creatinine clearance ≥ 30 mL/min

- Fasting glucose < 120 mg/dL

- Diabetes allowed provided blood glucose level meets the above criterion

- INR ≤ 1.5 times ULN

- LVEF ≥ 50% by MUGA or ECHO

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Willing to provide tissue and blood samples for research purposes

- Able to complete questionnaires by self or with assistance

- No other stage III or IV invasive cancer within the past 5 years

- No other malignancy requiring active treatment, except nonmelanoma skin canceror
carcinoma in situ of the cervix

- History of prior malignancy allowed providedpatient is not receiving other
specific treatment for their malignancy

- No current, active hepatic or biliary disease, except Gilbert syndrome's
orasymptomatic gallstones

- No New York Heart Association class III or IV cardiovascular disease

- No concurrent uncontrolled illness including, but not limited to, any of the
following:

- Poorly controlled diabetes

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness/social situation that would preclude compliance with
studyrequirements

- No co-morbid systemic illness or other severe concurrent disease that, in the
judgment of the investigator, would make the patient inappropriate for entry into
this study or interfere significantly with the proper assessment of the safety of the
prescribed study regimens

- Not immunocompromised (other than that related to the use of corticosteroids),
including known HIV-positivity with an AIDS-defining illness

- HIV-positive patients with a CD4 count within normal range and who have no
history of an AIDS-defining illness are eligible

- No other concurrent chemotherapeutic agents, biologic agents, or radiotherapy

- Prior hormonal therapy in the neoadjuvant, adjuvant, or metastatic setting allowed

- More than 6 weeks since prior major surgery, chemotherapy, or immunologic therapy

- More than 4 weeks since prior radiotherapy, except a single dose of palliative
radiotherapy or radiotherapy to a non-target lesion

- Prior radiotherapy to a target lesion is allowed only if there has been clear
progression of the lesion since completion of radiotherapy

- Recovered from prior radiotherapy

- No more than 2 prior chemotherapy regimens for metastatic disease

- No prior treatment with any therapy targeting IGF-I, IGF-II, or its receptors
(eithermonoclonal antibody or tyrosine kinase inhibitor) including, but not limited
to, anyof the following:

- Cixutumumab

- CP-751871

- AMG-479

- INSM-18

- MK-0646 (h7C10)

- 19D12

- R1507

- OSI-906

- BMS-536924

- PPP

- NVP-AEW541

- No other prior therapy targeting HER1 (EGFR) and/or HER2 (either monoclonal antibody
or tyrosine kinase inhibitor) including, but not limited to, any of the following:

- Lapatinib ditosylate

- Gefitinib

- Erlotinib hydrochloride

- Cetuximab

- Panitumumab

- No concurrent agents that would contraindicate study treatment, including any of the
following:

- CYP3A4 inhibitors and inducers, including grapefruit and grapefruit juice

- Warfarin, cimetidine,allopurinol, sorivudine or brivudine,ketoconazole,
itraconazole, ritonavir,amprenavir, or indinavir

- No concurrent treatment in another clinical study in which investigational procedures
are performed or investigational therapies are administered

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Outcome Description:

Analysis of the primary endpoint, PFS, will be performed using Cox regression with treatment group as a single covariate. The distribution of PFS time will be estimated by the Kaplan-Meier (1958) method for each treatment group. Median PFS times will be estimated using Kaplan-Meier estimates with 95% confidence intervals. Supplementary analyses of PFS include a Cox regression with treatment group and the stratification factors as covariates; as well as estimation of the 6-month PFS rate within each treatment group and comparison between the treatment groups using χ² testing.

Outcome Time Frame:

From randomization to the earliest date of documentation of disease progression, up to 5 years

Safety Issue:

No

Principal Investigator

Paul Haluska

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Central Cancer Treatment Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00665

NCT ID:

NCT00684983

Start Date:

July 2008

Completion Date:

Related Keywords:

  • HER2-positive Breast Cancer
  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer
  • IGF-1R
  • IMC-A12
  • Breast Neoplasms
  • Breast Neoplasms, Male

Name

Location

Albert Einstein College of MedicineBronx, New York  10461
Mayo ClinicRochester, Minnesota  55905
University of Washington Medical CenterSeattle, Washington  98195-6043
Hurley Medical CenterFlint, Michigan  48503
Medical City Dallas HospitalDallas, Texas  75230
Boulder Community HospitalBoulder, Colorado  80301-9019
Porter Adventist HospitalDenver, Colorado  80210
Rose Medical CenterDenver, Colorado  80220
Swedish Medical CenterEnglewood, Colorado  80110
Sky Ridge Medical CenterLone Tree, Colorado  80124
North Suburban Medical CenterThornton, Colorado  80229
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Fairview Ridges HospitalBurnsville, Minnesota  55337
Hutchinson Area Health CareHutchinson, Minnesota  55350
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
CentraCare ClinicSaint Cloud, Minnesota  56303
Glendale Memorial Hospital and Health CenterGlendale, California  91204
Sutter Health Western Division Cancer Research GroupGreenbrae, California  94904
South Georgia Medical CenterValdosta, Georgia  31603
Memorial Hospital of South BendSouth Bend, Indiana  46601
Marquette General HospitalMarquette, Michigan  49855
Akron General Medical CenterAkron, Ohio  44302
Lehigh Valley HospitalAllentown, Pennsylvania  18103
Illinois Masonic Medical CenterChicago, Illinois  60657
Staten Island University HospitalStaten Island, New York  10305
Via Christi Regional Medical CenterWichita, Kansas  67214
Iowa Methodist Medical CenterDes Moines, Iowa  50309
Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Group Health CooperativeSeattle, Washington  98112
Great Falls ClinicGreat Falls, Montana  59405
Thompson Cancer Survival CenterKnoxville, Tennessee  37916
Trinity Cancer Care CenterMinot, North Dakota  58701
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109
Montefiore Medical CenterBronx, New York  10467-2490
Mount Nittany Medical CenterState College, Pennsylvania  16803
North Colorado Medical CenterGreeley, Colorado  80631
McKee Medical CenterLoveland, Colorado  80539
Cancer Center of Kansas - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas - NewtonNewton, Kansas  67114
Cancer Center of Kansas - SalinaSalina, Kansas  67042
Cancer Center of Kansas - WellingtonWellington, Kansas  67152
Associates in Womens HealthWichita, Kansas  67203
Cancer Center of Kansas - WinfieldWinfield, Kansas  67156
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Bozeman Deaconess HospitalBozeman, Montana  59715
Big Sky OncologyGreat Falls, Montana  59405
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
Adena Regional Medical CenterChillicothe, Ohio  54601
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Harborview Medical CenterSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Welch Cancer CenterSheridan, Wyoming  82801
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Elkhart General HospitalElkhart, Indiana  46515
South Bend ClinicSouth Bend, Indiana  46617
Front Range Cancer SpecialistsFort Collins, Colorado  80528
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Alta Bates Summit Medical Center - Summit CampusOakland, California  94609
Sutter Solano Medical CenterVallejo, California  94589
Poudre Valley HospitalFort Collins, Colorado  80524
Community Cancer Center of MonroeMonroe, Michigan  48162
Iredell Memorial HospitalStatesville, North Carolina  28677
Bismarck Cancer CenterBismarck, North Dakota  58501
Grandview HospitalDayton, Ohio  45405
Lima Memorial HospitalLima, Ohio  45804
Mercy Hospital of TiffinTiffin, Ohio  44883
Fulton County Health CenterWauseon, Ohio  43567
Providence Milwaukie HospitalMilwaukie, Oregon  97222
Exempla Lutheran Medical CenterWheat Ridge, Colorado  80033
Mercy HospitalCoon Rapids, Minnesota  55433
Allenmore HospitalTacoma, Washington  98411-0414
Medical Oncology and Hematology AssociatesDes Moines, Iowa  50309
Ottumwa Regional Health CenterOttumwa, Iowa  52501
Bixby Medical CenterAdrian, Michigan  49221
Saint Joseph Mercy HospitalAnn Arbor, Michigan  48106
Fairview-Southdale HospitalEdina, Minnesota  55435
Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Regions HospitalSaint Paul, Minnesota  55101
Saint Francis Regional Medical CenterShakopee, Minnesota  55379
Rice Memorial HospitalWillmar, Minnesota  56201
Altru Cancer CenterGrand Forks, North Dakota  58206
Saint Luke's HospitalMaumee, Ohio  43537
Geisinger Medical GroupState College, Pennsylvania  16801
Highland General HospitalOakland, California  94602
Miami Valley HospitalDayton, Ohio  45409
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Lawrence Memorial HospitalLawrence, Kansas  66044
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
Northern Montana HospitalHavre, Montana  59501
Mary Rutan HospitalBellefontaine, Ohio  43311
Wayne HospitalGreenville, Ohio  45331
Knox Community HospitalMount Vernon, Ohio  43050
Fisher-Titus Medical CenterNorwalk, Ohio  44857
Clinton Memorial HospitalWilmington, Ohio  45177
Providence Centralia HospitalCentralia, Washington  98531-9027
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Rocky Mountain OncologyCasper, Wyoming  82609
Longmont United HospitalLongmont, Colorado  80501
Singing River HospitalPascagoula, Mississippi  39581
Greene Memorial HospitalXenia, Ohio  45385
Presbyterian HospitalCharlotte, North Carolina  28233-3549
Mayo Clinic in ArizonaScottsdale, Arizona  85259-5404
Mayo Clinic in FloridaJacksonville, Florida  32224
Memorial Medical CenterSpringfield, Illinois  62781
Phelps County Regional Medical CenterRolla, Missouri  65401
McLeod Regional Medical CenterFlorence, South Carolina  29501
Wellmont Holston Valley Hospital and Medical CenterKingsport, Tennessee  37662
Guardian Oncology and Center for WellnessMissoula, Montana  59804
Providence HospitalMobile, Alabama  36608
Bay Area Tumor InstituteOakland, California  94609
East Bay Radiation Oncology CenterCastro Valley, California  94546
Contra Costa Regional Medical CenterMartinez, California  94553-3156
Larry G Strieff MD Medical CorporationOakland, California  94609
Hennepin County Medical CenterMinneapolis, Minnesota  
Glens Falls HospitalGlens Falls, New York  12801
Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
Holy Cross HospitalFort Lauderdale, Florida  33308
El Camino HospitalMountain View, California  94040
Riverside Methodist HospitalColumbus, Ohio  43214
Licking Memorial HospitalNewark, Ohio  43055-2899
Cancer Center of Kansas - McPhersonMcPherson, Kansas  67460
Providence Portland Medical CenterPortland, Oregon  97213-3635
California Pacific Medical CenterSan Francisco, California  94115
Mid Dakota ClinicBismarck, North Dakota  58501
Columbus CCOPColumbus, Ohio  43206
Presbyterian - Saint Lukes Medical Center - Health OneDenver, Colorado  80218
Sacred Heart HospitalPensacola, Florida  32503
Wichita CCOPWichita, Kansas  67214-3882
Montana Cancer Consortium CCOPBillings, Montana  59101
Flower HospitalSylvania, Ohio  43560-2197
Metro-Minnesota CCOPSt. Louis Park, Minnesota  
Lakeview HospitalStillwater, Minnesota  55082
Decatur Memorial HospitalDecatur, Illinois  62526
Tulane University Health Sciences CenterNew Orleans, Louisiana  70112
Holy Cross HospitalSilver Spring, Maryland  20910
Montana Cancer SpecialistsMissoula, Montana  59807-7877
Desert Regional Medical CenterPalm Springs, California  92262
Florida HospitalOrlando, Florida  32803
Memorial Health University Medical CenterSavannah, Georgia  31404
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Clackamas Radiation Oncology CenterClackamas, Oregon  97015
Providence Newberg Medical CenterNewberg, Oregon  97132
Butler Memorial HospitalButler, Pennsylvania  16001
Mills - Peninsula HospitalsBurlingame, California  94010
Valley Medical Oncology Consultants-Castro ValleyCastro Valley, California  94546
Eden Hospital Medical CenterCastro Valley, California  94546
Valley Medical Oncology Consultants-FremontFremont, California  94538
Palo Alto Medical Foundation-Camino DivisionMountain View, California  94040
Bay Area Breast Surgeons IncOakland, California  94609
Tom K Lee IncOakland, California  94609
Palo Alto Medical Foundation Heath CarePalo Alto, California  94301
Valley Medical Oncology ConsultantsPleasanton, California  94588
Valley Care Health System - PleasantonPleasanton, California  94588
Doctors Medical Center- JC Robinson Regional Cancer CenterSan Pablo, California  94806
The Medical Center of AuroraAurora, Colorado  80012
Penrose-Saint Francis HealthcareColorado Springs, Colorado  80907
Saint Anthony Central HospitalDenver, Colorado  80204
Exempla Saint Joseph HospitalDenver, Colorado  80218
Colorado Cancer Research Program CCOPDenver, Colorado  80224-2522
Saint Mary's Hospital and Regional Medical CenterGrand Junction, Colorado  81502
Saint Mary Corwin Medical CenterPueblo, Colorado  81004
Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Middlesex HospitalMiddletown, Connecticut  06457
The Hospital of Central ConnecticutNew Britain, Connecticut  06050
Sacred Heart Medical Oncology Group - Davis HighwayPensacola, Florida  32514
John B Amos Cancer CenterColumbus, Georgia  31904
Rush - Copley Medical CenterAurora, Illinois  60504
Joliet Oncology-Hematology Associates LimitedJoliet, Illinois  60435
Carle Clinic-Urbana MainUrbana, Illinois  61801
Saint Francis Hospital and Health CentersBeech Grove, Indiana  46107
Fort Wayne Medical Oncology and Hematology Inc - State BoulevardFort Wayne, Indiana  46845
Saint Anthony Memorial Health CenterMichigan City, Indiana  46360
Reid Hospital and Health Care ServicesRichmond, Indiana  47374
McFarland ClinicAmes, Iowa  50010
Hematology Oncology Associates-Quad CitiesBettendorf, Iowa  52722
Cedar Rapids Oncology AssociationCedar Rapids, Iowa  52403
Mercy HospitalCedar Rapids, Iowa  52403
Medical Oncology and Hematology Associates-West Des MoinesClive, Iowa  50325
Genesis Medical Center - East CampusDavenport, Iowa  52803
Iowa Oncology Research Association CCOPDes Moines, Iowa  50309
Mercy CapitolDes Moines, Iowa  50307
Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates-Des MoinesDes Moines, Iowa  50309
Mercy Medical Center - North IowaMason City, Iowa  50401
Mercy Medical Center-Sioux CitySioux City, Iowa  51104
Saint Luke's Regional Medical CenterSioux City, Iowa  51104
Cancer Center of Kansas - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas-KingmanKingman, Kansas  67068
Cancer Center of Kansas - ParsonsParsons, Kansas  67357
Cancer Center of Kansas - PrattPratt, Kansas  67124
Cancer Center of Kansas-Wichita Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas - Main OfficeWichita, Kansas  67214
Hickman Cancer CenterAdrian, Michigan  49221
Michigan Cancer Research Consortium Community Clinical Oncology ProgramAnn Arbor, Michigan  48106
Oakwood HospitalDearborn, Michigan  48123
Saint John Hospital and Medical CenterDetroit, Michigan  48236
Green Bay Oncology - EscanabaEscanaba, Michigan  49431
Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Green Bay Oncology - Iron MountainIron Mountain, Michigan  49801
Allegiance HealthJackson, Michigan  49201
Sparrow HospitalLansing, Michigan  48912
Saint Mary Mercy HospitalLivonia, Michigan  48154
Mercy Memorial HospitalMonroe, Michigan  48162
Mercy Health Partners-Hackley CampusMuskegon, Michigan  49442
Saint Joseph Mercy OaklandPontiac, Michigan  48341-2985
Saint Joseph Mercy Port HuronPort Huron, Michigan  48060
Saint Mary's of MichiganSaginaw, Michigan  48601
Lakeland HospitalSt. Joseph, Michigan  49085
Saint John Macomb-Oakland HospitalWarren, Michigan  48093
Medini, Eitan MD (UIA Investigator)Alexandria, Minnesota  56308
Unity HospitalFridley, Minnesota  55432
Saint John's Hospital - HealtheastMaplewood, Minnesota  55109
Minnesota Oncology Hematology PA-MaplewoodMaplewood, Minnesota  55109
North Memorial Medical Health CenterRobbinsdale, Minnesota  55422
Saint Cloud HospitalSaint Cloud, Minnesota  56303
Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, Minnesota  55416
Minnesota Oncology and Hematology PA-WoodburyWoodbury, Minnesota  55125
Southeast Missouri HospitalCape Girardeau, Missouri  63701
Ozark Health Ventures LLC dba Cancer Research for The Ozarks SpringfieldSpringfield, Missouri  65802
Saint John's HospitalSpringfield, Missouri  65804
Cox Medical CenterSpringfield, Missouri  65807
Hematology-Oncology Centers of the Northern Rockies PCBillings, Montana  59101
Saint Vincent HealthcareBillings, Montana  59101
Billings ClinicBillings, Montana  59107-7000
Saint James Community Hospital and Cancer Treatment CenterButte, Montana  59701
Benefis Healthcare- Sletten Cancer InstituteGreat Falls, Montana  59405
Berdeaux, Donald MD (UIA Investigator)Great Falls, Montana  59405
Saint Peter's Community HospitalHelena, Montana  59601
Glacier Oncology PLLCKalispell, Montana  59901
Saint Patrick Hospital - Community HospitalMissoula, Montana  59802
Nevada Cancer Research Foundation CCOPLas Vegas, Nevada  89106
Orange Regional Medical CenterMiddletown, New York  10940
Wayne Memorial HospitalGoldsboro, North Carolina  27534
Margaret R Pardee Memorial HospitalHendersonville, North Carolina  28791
Kinston Medical Specialists PAKinston, North Carolina  28501
Saint Alexius Medical CenterBismarck, North Dakota  58501
Doctors HospitalColumbus, Ohio  43228
Grant Medical CenterColumbus, Ohio  43215
Mount Carmel Health Center WestColumbus, Ohio  43222
Good Samaritan Hospital - DaytonDayton, Ohio  45406
Dayton CCOPDayton, Ohio  45429
Samaritan North Health CenterDayton, Ohio  45415
Hematology Oncology Center IncorporatedElyria, Ohio  44035
Blanchard Valley HospitalFindlay, Ohio  45840
Atrium Medical Center-Middletown Regional HospitalFranklin, Ohio  45005-1066
Kettering Medical CenterKettering, Ohio  45429
Saint Rita's Medical CenterLima, Ohio  45801
Marietta Memorial HospitalMarietta, Ohio  45750
Toledo Radiation Oncology at Northwest Ohio Onocolgy CenterMaumee, Ohio  43537
Saint Charles HospitalOregon, Ohio  43616
North Coast Cancer CareSandusky, Ohio  44870
Toledo Community Hospital Oncology Program CCOPToledo, Ohio  43617
Mercy Cancer Center at Saint Anne Mercy HospitalToledo, Ohio  43623
University of ToledoToledo, Ohio  43614
Saint Vincent Mercy Medical CenterToledo, Ohio  43608
Upper Valley Medical CenterTroy, Ohio  45373
Saint Ann's HospitalWesterville, Ohio  43081
Genesis HealthCare SystemZanesville, Ohio  43701
Providence Saint Vincent Medical CenterPortland, Oregon  97225
Columbia River Oncology ProgramPortland, Oregon  97225
Geisinger Wyoming ValleyWilkes-Barre, Pennsylvania  18711
Conklin Regional Cancer CenterAberdeen, South Dakota  57401
The Don and Sybil Harrington Cancer CenterAmarillo, Texas  79106
Fredericksburg Oncology IncFredericksburg, Virginia  22401
Southwest VA Regional Cancer CenterNorton, Virginia  24273
Harrison Bremerton Hematology and OncologyBremerton, Washington  98310
Saint Francis HospitalFederal Way, Washington  98003
Columbia Basin Hematology and Oncology PLLCKennewick, Washington  99336
Providence - Saint Peter HospitalOlympia, Washington  98506-5166
Good Samaritan Community HospitalPuyallup, Washington  98372
Minor and James Medical PLLCSeattle, Washington  98104
The PolyclinicSeattle, Washington  98122
Swedish Medical Center-First HillSeattle, Washington  98122-4307
Northwest CCOPTacoma, Washington  98405
Multicare Health SystemTacoma, Washington  98415
Saint Clare HospitalTacoma, Washington  98499
Saint Joseph Medical CenterTacoma, Washington  98405
Edwards Comprehensive Cancer CenterHuntington, West Virginia  25701
Saint Vincent HospitalGreen Bay, Wisconsin  54301
Green Bay Oncology Limited at Saint Mary's HospitalGreen Bay, Wisconsin  54303
Saint Mary's HospitalGreen Bay, Wisconsin  54303
Green Bay Oncology at Saint Vincent HospitalGreen Bay, Wisconsin  54301-3526
Bay Area Medical CenterMarinette, Wisconsin  54143
Green Bay Oncology - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology - Sturgeon BaySturgeon Bay, Wisconsin  54235
University of Maryland Greenebaum Cancer CenterBaltimore, Maryland  21201
Jupiter Medical CenterJupiter, Florida  33458
Elkhart ClinicElkhart, Indiana  46515
Memorial Healthcare System - Joe DiMaggio Children's HospitalHollywood, Florida  33021
Mount Sinai Medical Center CCOPMiami Beach, Florida  33140
Michiana Hematology Oncology PC-ElkhartElkhart, Indiana  46514
Michiana Hematology Oncology PC-PlymouthPlymouth, Indiana  46563
Michiana Hematology Oncology PC-South BendSouth Bend, Indiana  46601
Michiana Hematology Oncology-PC WestvilleWestville, Indiana  46391
Cancer Center of Kansas-LiberalLiberal, Kansas  67901
Michiana Hematology Oncology PC-NilesNiles, Michigan  49120
Central Care Cancer Center-Carrie J Babb Cancer CenterBolivar, Missouri  65613
Skaggs Cancer CenterBranson, Missouri  65616
North Coast Cancer Care-ClydeClyde, Ohio  43410
Community Health Partners Regional Medical CenterElyria, Ohio  44035
University of Tennessee - KnoxvilleKnoxville, Tennessee  37920
Skagit Valley HospitalMt. Vernon, Washington  98273
Evergreen Hematology and Oncology PSSpokane, Washington  99218
Holy Family Memorial HospitalManitowoc, Wisconsin  54221
Salinas Valley MemorialSalinas, California  93901
Kaiser Permanente-Rock CreekLafayette, Colorado  80026
Saint Joseph Regional Medical CenterLewiston, Idaho  83501
Mount Clemens Regional Medical CenterMount Clemens, Michigan  48043
Southern Ohio Medical CenterPortsmouth, Ohio  45662
Memorial Hospital Of MartinsvilleMartinsville, Virginia  24115
Cancer Care Center at Island HospitalAnacortes, Washington  98221
Overlake Hospital Medical CenterBellevue, Washington  98004
Highline Medical Center-Main CampusBurien, Washington  98166
Providence Regional Cancer PartnershipEverett, Washington  98201
United General HospitalSedro-Woolley, Washington  98284
Gundersen LutheranLa Crosse, Wisconsin  54601
Saint Nicholas HospitalMadison, Wisconsin  53715
Kaiser Permanente-FranklinDenver, Colorado  80205
Siouxland Hematology Oncology AssociatesSioux City, Iowa  51101
Alta Bates Summit Medical Center-Herrick CampusBerkeley, California  94704
Carle Foundation - Carle Cancer CenterUrbana, Illinois  61801
Michiana Hematology Oncology PC-MishawakaMishawaka, Indiana  46545-1470
Oncology Associates at Mercy Medical CenterCedar Rapids, Iowa  52403
Marie Yeager Cancer CenterSaint Joseph, Michigan  49085
Hematology Oncology Associates of Central New York PCEast Syracuse, New York  13057
The Toledo Hospital/Toledo Children's HospitalToledo, Ohio  43606
Genesys Regional Medical Center-West Flint CampusFlint, Michigan  48532
Sanford Bismarck Medical CenterBismarck, North Dakota  58501
Toledo Clinic Cancer Centers-OregonOregon, Ohio  43616
Geisinger Medical Center-Cancer Center HazeltonHazleton, Pennsylvania  18201
Community Howard Regional HealthKokomo, Indiana  46904
Indiana University Health La Porte HospitalLa Porte, Indiana  46350
Saint Joseph Regional Medical Center-MishawakaMishawaka, Indiana  46545-1470
PeaceHealth Saint Joseph Medical CenterBellingham, Washington  98225
Aurora Cancer Care-Milwaukee WestWauwatosa, Wisconsin  53226
Springfield Regional Medical CenterSpringfield, Ohio  45505
Toledo Clinic Cancer Centers-Bowling GreenBowling Green, Ohio  43402
Toledo Clinic Cancer Centers-MaumeeMaumee, Ohio  43537-1839
Toledo Clinic Cancer Centers-ToledoToledo, Ohio  43623
Harrison Poulsbo Hematology and OncologyPoulsbo, Washington  98370
PeaceHealth Southwest Medical CenterVancouver, Washington  98664
Providence Willamette Falls Medical CenterOregon City, Oregon  97045