S1216, Phase III ADT+TAK-700 vs. ADT+Bicalutamide for Metastatic Prostate Cancer

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive18 and overNCI, OtherS1216
SWOG-S1216, NCI-2012-02876, NCT01809691

Trial Description

Summary

The purpose of this study is to compare overall survival in newly diagnosed metastatic prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700 versus ADT + bicalutamide.

Eligibility Criteria

Inclusion Criteria:

  • Clinical diagnosis of metastatic prostate cancer.
  • Serum testosterone within institutional limits of normal.
  • PSA ≥ 2 ng/mL within 90 days prior to initiation of androgen deprivation. therapy (for early induction) or prior to registration (for late induction).
  • DEXA scan within 2 years prior to registration.
  • ECG within 42 days prior to registration and QTc interval ≤ 460 msec.
  • LVEF within 42 days prior to registration and within institutional limits of normal.
  • Adequate hepatic function as evidenced by bilirubin ≤ 2 x institutional upper limit of normal (ULN), SGOT (AST) and SGPT (ALT) ≤ 3 x institutional ULN, or ≤ 5 x institutional ULN if liver metastases are present.
  • Adequate renal function as evidenced by calculated creatinine clearance ≥ 40 mL/min.
  • Adequate hematologic function as evidenced by leukocytes ≥ 3,000/mcL, absolute neutrophil count (ANC) ≥ 1,500/mcL, hemoglobin ≥ 9 g/dL, and platelets ≥ 100,000/mcL.
  • Zubrod performance status of 0 - 2. Zubrod performance status 3 will be allowed if from bone pain only.
  • ≥ 18 years of age.
  • Men of reproduction potential and those who are surgically sterilized (i.e., postvasectomy) must agree to practice effective barrier contraception or agree to abstain from intercourse while receiving treatment on this study and for at least 4 months after protocol treatment ends.

Exclusion Criteria:

  • Known brain metastases.
  • No more than 36 months of prior neoadjuvant and/or adjuvant hormonal therapy.
  • ≥ 6 months since completion of androgen deprivation therapy.
  • Prior or concurrent therapy with ketoconazole, aminoglutethimide or abiraterone acetate, or enzalutamide (MDV3100). Concurrent megestrol for hot flashes is allowed.
  • Prior chemotherapy for treatment of metastatic prostate cancer. Prior chemotherapy in the neoadjuvant or adjuvant setting is allowed.
  • ≥ 2 years since completion of chemotherapy in the neoadjuvant or adjuvant setting.
  • Concurrent use of experimental therapy is not allowed.
  • ≥ 30 days since prior medical castration for metastatic prostate cancer.
  • If method of castration is a LHRH agonist, the patient must be willing to continue the use of LHRH and add bicalutamide or TAK-700 during protocol treatment.
  • If the patient was on an antiandrogen (e.g. bicalutamide, flutamide), the patient must be willing to switch over to bicalutamide or TAK-700 (according to randomization).
  • Prior bilateral orchiectomy.
  • Concurrent use of LHRH antagonists (e.g. Degarelix)
  • Grade III/IV cardiac disease (as defined by the NYHA Criteria), thromboembolic event, unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia.
  • Uncontrolled hypertension (defined as blood pressure > 160 mmHg systolic and > 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the Screening visit) despite appropriate medical therapy.
  • Known human immunodeficiency virus (HIV)infection, active chronic hepatitis B or C, life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study.
  • History of primary and secondary adrenal insufficiency.
  • Hypersensitivity to TAK-700, to TAK-700 metabolites, to bicalutamide, or to LHRH agonists.
  • Gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of TAK-700, including difficulty swallowing oral medications.
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.

Trial Contact Information

Trial Lead Organizations/Sponsors

Southwest Oncology Group

  • Millennium Pharmaceuticals, Incorporated
  • National Cancer Institute
Neeraj Agarwal, M.D., Principal Investigator
Jennifer I Scott
Ph: 614-8808 Ext.1007
Email: jscott@swog.org

Trial Sites

U.S.A.

Arizona
Tucson

Arizona Cancer Center at UMC Orange Grove

Parminder Singh
Ph: 520-626-9008

Arizona Cancer Center at University Medical Center North

Parminder Singh
Ph: 520-626-9008

Arizona Cancer Center at University of Arizona Health Sciences Center

Parminder Singh
Ph: 520-626-9008

Arkansas
Little Rock

Veterans Affairs Medical Center - Little Rock

Rangaswamy Govindarajan
Ph: 501-686-8274

California
Antioch

Kaiser Permanente - Deer Valley

Tatjana Kolevska
Ph: 626-564-3455

Berkeley

Alta Bates Summit Comprehensive Cancer Center

Ari D Baron
Ph: 415-600-1182
Email: SchmidtJ@cpmcri.org

Burlingame

Peninsula Medical Center

Ari D Baron
Ph: 415-600-1182
Email: SchmidtJ@cpmcri.org

Duarte

City of Hope Comprehensive Cancer Center

Przemyslaw W. Twardowski
Ph: 800-826-4673
Email: becomingapatient@coh.org

Fremont

Kaiser Permanente - Fremont

Tatjana Kolevska
Ph: 626-564-3455

Fresno

Kaiser Permanente Fresno Medical Center

Tatjana Kolevska
Ph: 626-564-3455

La Jolla

Rebecca and John Moores UCSD Cancer Center

Frederick E Millard
Ph: 858-822-5354
Email: cancercto@ucsd.edu

Loma Linda

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Chien-Shing ( Chen
Ph: 909-558-3375

Los Angeles

USC/Norris Comprehensive Cancer Center and Hospital

David I. Quinn
Ph: 323-865-0451

David I. Quinn
Ph: 323-865-0451

Marysville

Fremont-Rideout Cancer Center

Primo N. Lara
Ph: 916-734-3089

Merced

Mercy Cancer Center at Mercy Medical Center

Prasad Pillai
Ph: 916-734-3089

Modesto

Kaiser Permanente-Modesto

Tatjana Kolevska
Ph: 626-564-3455

Memorial Medical Center

Jorge A Garcia-Young
Ph: 209-572-7116

Novato

Sutter Health Western Division Cancer Research Group

Ari D Baron
Ph: 415-600-1182
Email: SchmidtJ@cpmcri.org

Oakland

Kaiser Permanente-Oakland

Tatjana Kolevska
Ph: 626-564-3455

Orange

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

James E Ward
Ph: 877-827-8839
Email: ucstudy@uci.edu

Paradise

Feather River Hospital Cancer Center

Sam Mazj
Ph: 530-876-7995
Email: haleew@ah.org

Pasadena

Keck Medical Center of USC

David I. Quinn
Ph: 323-865-0451

Redwood City

Kaiser Permanente Medical Center - Redwood City

Tatjana Kolevska
Ph: 626-564-3455

Richmond

Kaiser Permanente Medical Center - Richmond

Tatjana Kolevska
Ph: 626-564-3455

Roseville

Kaiser Permanente Medical Center - Roseville

Tatjana Kolevska
Ph: 626-564-3455

Sacramento

Kaiser Permanente Medical Center - Sacramento

Tatjana Kolevska
Ph: 626-564-3455

South Sacramento Kaiser-Permanente Medical Center

Tatjana Kolevska
Ph: 626-564-3455

University of California Davis Cancer Center

Primo N. Lara
Ph: 916-734-3089

Saint Helena

Saint Helena Hospital

Gregory B Smith
Ph: 707-967-3698

San Francisco

California Pacific Medical Center - California Campus

Ari D Baron
Ph: 415-600-1182
Email: SchmidtJ@cpmcri.org

Kaiser Permanente Medical Center - San Francisco Geary Campus

Tatjana Kolevska
Ph: 626-564-3455

UCSF Helen Diller Family Comprehensive Cancer Center

Terence W Friedlander
Ph: 877-827-3222

San Jose

Kaiser Permanente Medical Center - Santa Teresa

Tatjana Kolevska
Ph: 626-564-3455

San Leandro

Kaiser Permanente Medical Center - Hayward

Tatjana Kolevska
Ph: 626-564-3455

San Rafael

Kaiser Foundation Hospital - San Rafael

Tatjana Kolevska
Ph: 626-564-3455

Santa Clara

Kaiser Permanente Medical Center - Santa Clara Homestead Campus

Tatjana Kolevska
Ph: 626-564-3455

Santa Rosa

Kaiser Permanente Medical Center - Santa Rosa

Tatjana Kolevska
Ph: 626-564-3455

Sutter Pacific Medical Foundation

Ari D Baron
Ph: 415-600-1182
Email: SchmidtJ@cpmcri.org

South San Francisco

Kaiser Permanente Medical Center - South San Francisco

Tatjana Kolevska
Ph: 626-564-3455

Stockton

Kaiser Permanente Medical Facility - Stockton

Tatjana Kolevska
Ph: 626-564-3455

Truckee

Tahoe Forest Cancer Center

Primo N. Lara
Ph: 916-734-3089

Vacaville

Kaiser Permanente Medical Center - Vacaville

Tatjana Kolevska
Ph: 626-564-3455

Vallejo

Kaiser Permanente Medical Center - Vallejo

Tatjana Kolevska
Ph: 626-564-3455

Sutter Solano Medical Center

Ari D Baron
Ph: 415-600-1182
Email: SchmidtJ@cpmcri.org

Walnut Creek

Kaiser Permanente Medical Center - Walnut Creek

Tatjana Kolevska
Ph: 626-564-3455

Colorado
Aurora

University of Colorado Cancer Center at UC Health Sciences Center

Paul D Maroni
Ph: 720-848-0650

Connecticut
Greenwich

Bendheim Cancer Center at Greenwich Hospital

Daniel P. Petrylak
Ph: 203-785-5702

Norwich

Eastern Connecticut Hematology and Oncology Associates

Dennis E. Slater
Ph: 860-886-8362

Delaware
Lewes

Tunnell Cancer Center at Beebe Medical Center

Stephen Scott Grubbs
Ph: 302-733-6227

Newark

Helen F. Graham Cancer Center at Christiana Hospital

Stephen Scott Grubbs
Ph: 302-733-6227

Seaford

Nanticoke Memorial Hospital

Stephen Scott Grubbs
Ph: 302-733-6227

District of Columbia
Washington

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Nancy Ann Dawson
Ph: 202-444-0381

Sibley Memorial Hospital

Channing J Paller
Ph: 410-955-8804
Email: jhcccro@jhmi.edu

Veterans Affairs Medical Center - Washington, DC

Anthony G Arcenas
Ph: 877-328-2621

Washington Cancer Institute at Washington Hospital Center

Nancy Ann Dawson
Ph: 202-444-0381

Florida
Fort Lauderdale

Broward General Medical Center Cancer Center

Archana Maini
Ph: 954-355-5346

Lakeland

Lakeland Regional Cancer Center at Lakeland Regional Medical Center

Gameel B Hodge
Ph: 863-904-1900

Orlando

Florida Hospital Cancer Institute at Florida Hospital Orlando

Lee M. Zehngebot
Ph: 407-303-5623

M.D. Anderson Cancer Center at Orlando

Daniel Landau
Ph: 321-841-7246
Email: CancerClinicalTrials@orlandohealth.com

Tampa

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Shilpa Gupta
Ph: 800-456-7121
Email: canceranswers@moffitt.org

Georgia
Columbus

John B. Amos Cancer Center

Andrew W. Pippas
Ph: 706-660-6404

Decatur

Veterans Affairs Medical Center - Atlanta (Decatur)

Wayne B. Harris
Ph: 404-778-1868

Gainesville

Northeast Georgia Medical Center

Charles H. Nash
Ph: 770-219-8800
Email: cancerpatient.navigator@nghs.com

Savannah

Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler

Mark A. Taylor
Ph: 912-350-8568

Hawaii
Aiea

Kapiolani Medical Center at Pali Momi

Jeffrey L. Berenberg
Ph: 808-586-2979

Honolulu

Cancer Research Center of Hawaii

Jeffrey L. Berenberg
Ph: 808-586-2979

Kaiser Permanente - Moanalua Medical Center and Clinic

Tatjana Kolevska
Ph: 626-564-3455

OnCare Hawaii, Incorporated - Kuakini

Jeffrey L. Berenberg
Ph: 808-586-2979

Jeffrey L. Berenberg
Ph: 808-586-2979

OnCare Hawaii, Incorporated - Lusitana

Jeffrey L. Berenberg
Ph: 808-586-2979

Queen's Cancer Institute at Queen's Medical Center

Jeffrey L. Berenberg
Ph: 808-586-2979

Tripler Army Medical Center

Jeffrey L. Berenberg
Ph: 808-586-2979

Idaho
Boise

Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

Philip J. Stella
Ph: 734-712-4673

Illinois
Bloomington

Illinois CancerCare - Bloomington

Nguyet A Le-Lindqwister
Ph: 800-793-2262

St. Joseph Medical Center

Nguyet A Le-Lindqwister
Ph: 800-793-2262

Canton

Illinois CancerCare - Canton

Nguyet A Le-Lindqwister
Ph: 800-793-2262

Carthage

Illinois CancerCare - Carthage

Nguyet A Le-Lindqwister
Ph: 800-793-2262

Chicago

Louis A. Weiss Memorial Hospital

Keith L. Shulman
Ph: 773-564-5044

Mount Sinai Hospital Medical Center

Pam G. Khosla
Ph: 773-257-5960
Email: suhi@sinai.org

University of Chicago Cancer Research Center

Chadi Nabhan
Ph: 773-834-7424

University of Illinois Cancer Center

David J. Peace
Ph: 312-355-3046

Decatur

CCOP - Central Illinois

Neeraj Agarwal
Ph: 801-587-4765
Email: neeraj.agarwal@hci.utah.edu

Decatur Memorial Hospital Cancer Care Institute

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Eureka

Illinois CancerCare - Eureka

Nguyet A Le-Lindqwister
Ph: 800-793-2262

Evanston

CCOP - Evanston

Daniel H. Shevrin
Ph: 847-570-2109

Galesburg

Galesburg Clinic, PC

Nguyet A Le-Lindqwister
Ph: 800-793-2262

Medical and Surgical Specialists, LLC

Nguyet A Le-Lindqwister
Ph: 800-793-2262

Glenview

Glenbrook Hospital

Daniel H. Shevrin
Ph: 847-570-2109

Highland Park

Highland Park Hospital

Daniel H. Shevrin
Ph: 847-570-2109

Hines

Veterans Affairs Medical Center - Hines

Elizabeth Henry
Ph: 708-226-4357

Joliet

Joliet Oncology-Hematology Associates, Limited - West

Kulumani M Sivarajan
Ph: 815-730-3098
Email: maureenc@jolietoncology.com

Kewanee

Illinois CancerCare - Kewanee Clinic

Nguyet A Le-Lindqwister
Ph: 800-793-2262

Macomb

Illinois CancerCare - Macomb

Nguyet A Le-Lindqwister
Ph: 800-793-2262

Maywood

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Ellen R. Gaynor
Ph: 708-226-4357

Moline

Trinity Cancer Center at Trinity Medical Center - 7th Street Campus

David M Spector
Ph: 309-779-4200

Ottawa

Illinois CancerCare - Ottawa

Nguyet A Le-Lindqwister
Ph: 800-793-2262

Pekin

Cancer Treatment Center at Pekin Hospital

Nguyet A Le-Lindqwister
Ph: 800-793-2262

Illinois CancerCare - Pekin

Nguyet A Le-Lindqwister
Ph: 800-793-2262

Peoria

Illinois CancerCare - Peoria

Nguyet A Le-Lindqwister
Ph: 800-793-2262

Methodist Medical Center of Illinois

Nguyet A Le-Lindqwister
Ph: 800-793-2262

OSF St. Francis Medical Center

Nguyet A Le-Lindqwister
Ph: 800-793-2262

Peru

Illinois CancerCare - Princeton

Nguyet A Le-Lindqwister
Ph: 800-793-2262

Princeton

Illinois CancerCare - Princeton

Nguyet A Le-Lindqwister
Ph: 800-793-2262

River Forest

West Suburban Center for Cancer Care

Keith L. Shulman
Ph: 773-564-5044

Springfield

Regional Cancer Center at Memorial Medical Center

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Urbana

Carle Cancer Center at Carle Foundation Hospital

Vamsi K Vasireddy
Ph: 800-446-5532

Iowa
Ames

McFarland Clinic, PC

Joseph James Merchant
Ph: 515-239-2621

Iowa City

Holden Comprehensive Cancer Center at University of Iowa

Daniel A Vaena
Ph: 800-237-1225

Veterans Affairs Medical Center - Iowa City

Daniel A Vaena
Ph: 800-237-1225

Kansas
Chanute

Cancer Center of Kansas, PA - Chanute

Shaker R. Dakhil
Ph: 316-262-4467

Dodge City

Cancer Center of Kansas, PA - Dodge City

Shaker R. Dakhil
Ph: 316-262-4467

El Dorado

Cancer Center of Kansas, PA - El Dorado

Shaker R. Dakhil
Ph: 316-262-4467

Fort Scott

Cancer Center of Kansas - Fort Scott

Shaker R. Dakhil
Ph: 316-262-4467

Great Bend

St. Rose Ambulatory and Surgery Center

Peter J. VanVeldhuizen
Ph: 800-525-1483

Hays

Hays Medical Center

Peter J. VanVeldhuizen
Ph: 800-525-1483

Independence

Cancer Center of Kansas-Independence

Shaker R. Dakhil
Ph: 316-262-4467

Kansas City

Kansas City Cancer Centers - West

Peter J. VanVeldhuizen
Ph: 800-525-1483

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Peter J. VanVeldhuizen
Ph: 800-525-1483

Kingman

Cancer Center of Kansas, PA - Kingman

Shaker R. Dakhil
Ph: 316-262-4467

Lawrence

Lawrence Memorial Hospital

Shaker R. Dakhil
Ph: 316-262-4467

Liberal

Cancer Center of Kansas, PA - Liberal

Shaker R. Dakhil
Ph: 316-262-4467

Newton

Cancer Center of Kansas, PA - Newton

Shaker R. Dakhil
Ph: 316-262-4467

Overland Park

Kansas City Cancer Centers - Southwest

Peter J. VanVeldhuizen
Ph: 800-525-1483

Parsons

Cancer Center of Kansas, PA - Parsons

Shaker R. Dakhil
Ph: 316-262-4467

Pratt

Cancer Center of Kansas, PA - Pratt

Shaker R. Dakhil
Ph: 316-262-4467

Salina

Cancer Center of Kansas, PA - Salina

Shaker R. Dakhil
Ph: 316-262-4467

Tammy Walker Cancer Center at Salina Regional Health Center

Peter J. VanVeldhuizen
Ph: 800-525-1483

Topeka

St. Francis Comprehensive Cancer Center

Peter J. VanVeldhuizen
Ph: 800-525-1483

Veterans Affairs Medical Center - Topeka (O'Neil)

Ace Allen
Ph: 800-525-1483

Wellington

Cancer Center of Kansas, PA - Wellington

Shaker R. Dakhil
Ph: 316-262-4467

Wichita

Associates in Women's Health, PA - North Hillside

Shaker R. Dakhil
Ph: 316-262-4467

Cancer Center of Kansas, PA - Medical Arts Tower

Shaker R. Dakhil
Ph: 316-262-4467

Cancer Center of Kansas, PA - Wichita

Shaker R. Dakhil
Ph: 316-262-4467

CCOP - Wichita

Shaker R. Dakhil
Ph: 316-262-4467

Via Christi Cancer Center at Via Christi Regional Medical Center

Shaker R. Dakhil
Ph: 316-262-4467

Winfield

Cancer Center of Kansas, PA - Winfield

Shaker R. Dakhil
Ph: 316-262-4467

Kentucky
Lexington

University of Kentucky Chandler Medical Center

Peng Wang
Ph: 859-257-3379

Louisiana
Baton Rouge

Ochsner Health Center - Bluebonnet

Marc R Matrana
Ph: 888-562-4763

New Orleans

Medical Center of Louisiana - New Orleans

Augusto C Ochoa
Ph: 504-568-2428
Email: emede1@lsuhsc.edu

Ochsner Cancer Institute at Ochsner Clinic Foundation

Marc R Matrana
Ph: 888-562-4763

Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans

Augusto C Ochoa
Ph: 504-568-2428
Email: emede1@lsuhsc.edu

Shreveport

Feist-Weiller Cancer Center at Louisiana State University Health Sciences

Donald A. Elmajian
Ph: 318-813-1412

Maine
Augusta

Harold Alfond Center for Cancer Care

Thomas Henry Openshaw
Ph: 207-973-4274

Bangor

CancerCare of Maine at Eastern Maine Medical Center

Thomas Henry Openshaw
Ph: 207-973-4274

Rockport

Penobscot Bay Medical Center Cancer Care Center

Thomas Henry Openshaw
Ph: 207-973-4274

Maryland
Baltimore

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Channing J Paller
Ph: 410-955-8804
Email: jhcccro@jhmi.edu

Massachusetts
Boston

Boston University Cancer Research Center

Gretchen A Gignac
Ph: 617-638-8265

Brighton

Caritas St. Elizabeth's Medical Center

Olga Kozyreva
Ph: 617-789-2903

Burlington

Lahey Clinic Medical Center - Burlington

Jacob M Sands
Ph: 781-744-8027

Fall River

Hudner Oncology Center at Saint Anne's Hospital - Fall River

John L Yang
Ph: 508-674-5600

Quincy

Commonwealth Hematology-Oncology, PC - Quincy

James R. Everett
Ph: 781-337-9091

Springfield

Baystate Medical Center

Leslie Marion Howard
Ph: 413-794-3565
Email: tamara.wrenn@baystatehealth.org

Michigan
Ann Arbor

CCOP - Michigan Cancer Research Consortium

Neeraj Agarwal
Ph: 801-587-4765
Email: neeraj.agarwal@hci.utah.edu

Saint Joseph Mercy Cancer Center

Philip J. Stella
Ph: 734-712-4673

University of Michigan Comprehensive Cancer Center

Ajjai S Alva
Ph: 800-865-1125
Email: burton@bcm.edu

Neeraj Agarwal
Ph: 801-587-4765
Email: neeraj.agarwal@hci.utah.edu

Battle Creek

Battle Creek Health System Cancer Care Center

Gilbert D Padula
Ph: 616-685-5225

Detroit

Van Elslander Cancer Center at St. John Hospital and Medical Center

Philip J. Stella
Ph: 734-712-4673

Grand Rapids

Butterworth Hospital at Spectrum Health

Gilbert D Padula
Ph: 616-685-5225

Kalamazoo

West Michigan Cancer Center

Raymond Sterling Lord
Ph: 269-373-7458

Lansing

Sparrow Regional Cancer Center

Philip J. Stella
Ph: 734-712-4673

Pontiac

St. Joseph Mercy Oakland

Philip J. Stella
Ph: 734-712-4673

Reed City

Spectrum Health Reed City Hospital

Gilbert D Padula
Ph: 616-685-5225

Royal Oak

William Beaumont Hospital - Royal Oak Campus

Jason M Hafron
Ph: 248-786-0467
Email: osterhoutd@michiganurology.com

Traverse City

Munson Medical Center

Gilbert D Padula
Ph: 616-685-5225

Troy

William Beaumont Hospital - Troy Campus

Jason M Hafron
Ph: 248-786-0467
Email: osterhoutd@michiganurology.com

Warren

St. John Macomb Hospital

Philip J. Stella
Ph: 734-712-4673

Minnesota
Bemidji

MeritCare Bemidji

Preston D. Steen
Ph: 701-234-6161

Burnsville

Fairview Ridges Hospital

Patrick J. Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Coon Rapids

Mercy and Unity Cancer Center at Mercy Hospital

Patrick J. Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Duluth

CCOP - Duluth

Bret E Friday
Ph: 888-203-7267

Edina

Fairview Southdale Hospital

Patrick J. Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Fergus Falls

Lake Region Healthcare Corporation-Cancer Care

Bret E Friday
Ph: 888-203-7267

Maplewood

HealthEast Cancer Care at St. John's Hospital

Patrick J. Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Minnesota Oncology - Maplewood

Patrick J. Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Minneapolis

Hennepin County Medical Center - Minneapolis

Patrick J. Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

Patrick J. Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Robbinsdale

Humphrey Cancer Center at North Memorial Outpatient Center

Patrick J. Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Rochester

Mayo Clinic Cancer Center

Manish Kohli
Ph: 507-538-7623

Saint Cloud

CentraCare Clinic - Women and Children

Donald J Jurgens
Ph: 877-229-4907
Email: coborncancercenter@centracare.com

Saint Louis Park

CCOP - Metro-Minnesota

Patrick J. Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Park Nicollet Cancer Center

Patrick J. Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Saint Paul

Regions Hospital Cancer Care Center

Patrick J. Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

United Hospital

Patrick J. Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Shakopee

St. Francis Cancer Center at St. Francis Medical Center

Patrick J. Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Stillwater

Lakeview Hospital

Patrick J. Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Mississippi
Jackson

University of Mississippi Cancer Clinic

Barbara S Craft
Ph: 601-815-6700

Missouri
Cape Girardeau

Saint Francis Medical Center

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Columbia

Ellis Fischel Cancer Center at University of Missouri - Columbia

Carl E. Freter
Ph: 573-882-7440

Kansas City

Kansas City Cancer Centers - North

Peter J. VanVeldhuizen
Ph: 800-525-1483

Kansas City Cancer Centers - South

Peter J. VanVeldhuizen
Ph: 800-525-1483

Truman Medical Center - Hospital Hill

Peter J. VanVeldhuizen
Ph: 800-525-1483

Veterans Affairs Medical Center - Kansas City

Peter J. VanVeldhuizen
Ph: 800-525-1483

Lee's Summit

Kansas City Cancer Centers - East

Peter J. VanVeldhuizen
Ph: 800-525-1483

Rolla

Phelps County Regional Medical Center

Jay W Carlson
Ph: 800-821-7532
Email: sherrijr@iora.org

Saint Louis

David C. Pratt Cancer Center at St. John's Mercy

Jay W Carlson
Ph: 800-821-7532
Email: sherrijr@iora.org

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

Joel Picus
Ph: 800-600-3606
Email: info@siteman.wustl.edu

Springfield

Hulston Cancer Center at Cox Medical Center South

Jay W Carlson
Ph: 800-821-7532
Email: sherrijr@iora.org

Montana
Billings

Billings Clinic Cancer Center - 801 N 29th Street

Benjamin Thomas Marchello
Ph: 800-648-6274

CCOP - Montana Cancer Consortium

Neeraj Agarwal
Ph: 801-587-4765
Email: neeraj.agarwal@hci.utah.edu

St. Vincent Healthcare Cancer Care Services

Benjamin Thomas Marchello
Ph: 800-648-6274

Bozeman

Bozeman Deaconess Cancer Center

Benjamin Thomas Marchello
Ph: 800-648-6274

Great Falls

Benefis Sletten Cancer Institute

Benjamin Thomas Marchello
Ph: 800-648-6274

Nebraska
Omaha

Methodist Estabrook Cancer Center

Ralph Hauke
Ph: 402-354-5144

Nevada
Las Vegas

CCOP - Nevada Cancer Research Foundation

John Allan Ellerton
Ph: 702-384-0013

Reno

Renown Institute for Cancer at Renown Regional Medical Center

Deepa R Mocherla
Ph: 775-982-4400

New Hampshire
Concord

New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care

Douglas Jay Weckstein
Ph: 603-224-2556

Hooksett

New Hampshire Oncology - Hematology, PA - Hooksett

Neeraj Agarwal
Ph: 801-587-4765
Email: neeraj.agarwal@hci.utah.edu

Laconia

Lakes Region General Hospital

Douglas Jay Weckstein
Ph: 603-224-2556

New Jersey
East Orange

Veterans Affairs Medical Center - East Orange

Basil S. Kasimis
Ph: 800-475-2336
Email: patricia.goyer@med.va.gov

New Brunswick

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

Tina Mayer
Ph: 732-235-8675

Sparta

Frederick R. and Betty M. Smith Cancer Treatment Center

Jean H Hoffman-Censits
Ph: 215-955-6084

New Mexico
Albuquerque

Hematology Oncology Associates, PC

Richard C Lauer
Ph: 505-272-6972

University of New Mexico Cancer Center

Richard C Lauer
Ph: 505-272-6972

Santa Fe

New Mexico Cancer Care Associates

Richard C Lauer
Ph: 505-272-6972

New York
Bronx

Montefiore Medical Center

Benjamin A Gartrell
Ph: 718-904-2730
Email: aecc@aecom.yu.edu

Brooklyn

Veterans Affairs Medical Center - Brooklyn

Andrea Nadine Wiesel Leaf
Ph: 800-877-6976

Buffalo

Roswell Park Cancer Institute

Ellis G. Levine
Ph: 877-275-7724

Veterans Affairs Medical Center - Buffalo

Lynn Marie Steinbrenner
Ph: 716-862-3191

East Syracuse

CCOP - Hematology-Oncology Associates of Central New York

Jeffrey J. Kirshner
Ph: 315-472-7504

Glens Falls

Charles R. Wood Cancer Center at Glens Falls Hospital

John P Stoutenburg
Ph: 518-926-6700

Middletown

Tucker Center for Cancer Care at Orange Regional Medical Center

Jeffrey M. Stewart
Ph: 845-342-7609

New York

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Edward P. Gelmann
Ph: 212-305-8615

New York University Medical Center

Anna C. Ferrari
Ph: 212-263-4434
Email: prmc.coordinator@nyumc.org

New York Weill Cornell Cancer Center at Cornell University

Scott Tagawa
Ph: 212-746-1848

Rochester

James P. Wilmot Cancer Center at University of Rochester Medical Center

Jonathan W Friedberg
Ph: 585-275-5830

North Carolina
Asheville

Mission Hospitals - Memorial Campus

Christopher H Chay
Ph: 828-213-4150

Charlotte

Blumenthal Cancer Center at Carolinas Medical Center

Earle F Burgess
Ph: 704-355-2884

Concord

Batte Cancer Center at Northeast Medical Center

Earle F Burgess
Ph: 704-355-2884

Hendersonville

Comprehensive Cancer Center at Pardee Hospital

James E. Radford
Ph: 828-696-4716

Hendersonville Hematology and Oncology

James E. Radford
Ph: 828-696-4716

Park Ridge Hospital Breast Health Center

James Dewitt Bearden
Ph: 800-486-5941

Kinston

Kinston Medical Specialists

Peter R. Watson
Ph: 252-559-2200

Monroe

Edwards Cancer Center at Union Regional Medical Center

Earle F Burgess
Ph: 704-355-2884

Shelby

Cleveland Regional Medical Center

Earle F Burgess
Ph: 704-355-2884

Statesville

Iredell Memorial Hospital

Ruby A. Grimm
Ph: 704-873-5661

North Dakota
Bismarck

Medcenter One Hospital Cancer Care Center

Preston D. Steen
Ph: 701-234-6161

Fargo

Roger Maris Cancer Center at MeritCare Hospital

Preston D. Steen
Ph: 701-234-6161

Preston D. Steen
Ph: 701-234-6161

Sanford Clinic North-Fargo

Preston D. Steen
Ph: 701-234-6161

Ohio
Akron

Summa Center for Cancer Care at Akron City Hospital

Jennifer E Payne
Ph: 330-375-6101

Barberton

Barberton Citizens Hospital

Jennifer E Payne
Ph: 330-375-6101

Chillicothe

Adena Regional Medical Center

J. Philip Kuebler
Ph: 614-566-3275

Cincinnati

University of Cincinnati

John Charles Morris
Ph: 513-558-4553
Email: uchealthnews@uc.edu

Cleveland

MetroHealth Cancer Care Center at MetroHealth Medical Center

Bruce J. Averbook
Ph: 216-778-8526
Email: kbauchens@metrohealth.org

Columbus

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

J. Paul Monk
Ph: 866-627-7616
Email: osu@emergingmed.com

CCOP - Columbus

J. Philip Kuebler
Ph: 614-566-3275

Grant Medical Center Cancer Care

J. Philip Kuebler
Ph: 614-566-3275

Mount Carmel Health - West Hospital

J. Philip Kuebler
Ph: 614-566-3275

Riverside Methodist Hospital Cancer Care

J. Philip Kuebler
Ph: 614-566-3275

Zangmeister Center

J. Philip Kuebler
Ph: 614-566-3275

Dayton

David L. Rike Cancer Center at Miami Valley Hospital

Howard M. Gross
Ph: 765-983-3000

Samaritan North Cancer Care Center

Howard M. Gross
Ph: 765-983-3000

Lima

St. Rita's Medical Center

Henry Gerad
Ph: 419-226-9617

Marietta

Strecker Cancer Center at Marietta Memorial Hospital

J. Philip Kuebler
Ph: 614-566-3275

Portsmouth

Southern Ohio Medical Center Cancer Center

J. Philip Kuebler
Ph: 614-566-3275

Springfield

Community Hospital of Springfield and Clark County

J. Philip Kuebler
Ph: 614-566-3275

Troy

UVMC Cancer Care Center at Upper Valley Medical Center

Howard M. Gross
Ph: 765-983-3000

Westerville

Mount Carmel St. Ann's Cancer Center

J. Philip Kuebler
Ph: 614-566-3275

Wright-Patterson Afb

United States Air Force Medical Center - Wright-Patterson

Brandon J Cutler
Ph: 937-257-1398

Oklahoma
Oklahoma City

Stephenson Cancer Center at the University of Oklahoma

George B Selby
Ph: 405-271-4272
Email: julie-traylor@ouhsc.edu

Oregon
Gresham

Legacy Mount Hood Medical Center

Jacqueline Vuky
Ph: 503-299-6500

Portland

Kaiser Permanente Health Care - Portland

Nagendra Tirumali
Ph: 503-335-2400

Knight Cancer Institute at Oregon Health and Science University

Julie N Graff
Ph: 503-494-1080
Email: trials@ohsu.edu

Legacy Good Samaritan Hospital & Comprehensive Cancer Center

Jacqueline Vuky
Ph: 503-299-6500

Tualatin

Legacy Meridian Park Hospital

Jacqueline Vuky
Ph: 503-299-6500

Pennsylvania
Doylestown

Doylestown Hospital Cancer Center

Mitchell Alden
Ph: 215-345-2378
Email: lheacock@dh.org

Hershey

Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center

Monika Joshi
Ph: 717-531-3779
Email: CTO@hmc.psu.edu

Philadelphia

Fox Chase Cancer Center - Philadelphia

Yu-Ning Wong
Ph: 215-728-4790

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Jean H Hoffman-Censits
Ph: 215-955-6084

Scranton

Hematology and Oncology Associates of North East Pennsylvania

Jean H Hoffman-Censits
Ph: 215-955-6084

West Reading

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

Terrence P. Cescon
Ph: 610-988-9323

South Carolina
Anderson

AnMed Cancer Center

James Dewitt Bearden
Ph: 800-486-5941

Charleston

Hollings Cancer Center at Medical University of South Carolina

Michael B. Lilly
Ph: 843-792-9321
Email: ucstudy@uci.edu

Roper St. Francis Cancer Center at Roper Hospital

James Michael Orcutt
Ph: 843-720-8386
Email: elizabeth.strojny@roperstfrancis.com

Florence

McLeod Regional Medical Center

Rajesh Bajaj
Ph: 843-679-7256

Greenville

Bon Secours St. Francis Health System

James Dewitt Bearden
Ph: 800-486-5941

Cancer Centers of the Carolinas - Faris Road

Jeffrey Kent Giguere
Ph: 864-241-6251

Cancer Centers of the Carolinas - Grove Commons

Jeffrey Kent Giguere
Ph: 864-241-6251

CCOP - Greenville

Jeffrey Kent Giguere
Ph: 864-241-6251

Greenville Memorial Hospital

Jeffrey Kent Giguere
Ph: 864-241-6251

Greenwood

Self Regional Cancer Center at Self Regional Medical Center

Michael B. Lilly
Ph: 843-792-9321
Email: ucstudy@uci.edu

Greer

Cancer Centers of the Carolinas - Greer Radiation Oncology

Jeffrey Kent Giguere
Ph: 864-241-6251

Seneca

Cancer Centers of the Carolinas - Seneca

Jeffrey Kent Giguere
Ph: 864-241-6251

Spartanburg

Cancer Centers of the Carolinas - Spartanburg

Jeffrey Kent Giguere
Ph: 864-241-6251

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

James Dewitt Bearden
Ph: 800-486-5941

South Dakota
Sioux Falls

Sanford Cancer Center at Sanford USD Medical Center

Miroslaw A Mazurczak
Ph: 605-328-1367

Miroslaw A Mazurczak
Ph: 605-328-1367

Tennessee
Chattanooga

Erlanger Cancer Center at Erlanger Hospital - Baroness

Larry L. Schlabach
Ph: 423-778-6947

Texas
Dallas

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Kevin D Courtney
Ph: 214-648-7097

Houston

Ben Taub General Hospital

Nicholas Mitsiades
Ph: 713-798-1354
Email: burton@bcm.edu

Dan L. Duncan Cancer Center at Baylor College of Medicine

Nicholas Mitsiades
Ph: 713-798-1354
Email: burton@bcm.edu

Utah
Salt Lake City

Huntsman Cancer Institute at University of Utah

Neeraj Agarwal
Ph: 801-581-4477
Email: clinical.trials@hci.utah.edu

Virginia
Martinsville

Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County

Sreedhar Katragadda
Ph: 276-666-7827

Washington
Bellingham

St. Joseph Cancer Center

Gary E Goodman
Ph: 206-386-2323
Email: patra.grevstad@swedish.org

Mount Vernon

Skagit Valley Hospital Cancer Care Center

Gary E Goodman
Ph: 206-386-2323
Email: patra.grevstad@swedish.org

Seattle

Minor and James Medical, PLLC

Gary E Goodman
Ph: 206-386-2323
Email: patra.grevstad@swedish.org

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Gary E Goodman
Ph: 206-386-2323
Email: patra.grevstad@swedish.org

Spokane

Rockwood Clinic Cancer Treatment Center

Gary E Goodman
Ph: 206-386-2323
Email: patra.grevstad@swedish.org

Vancouver

Legacy Salmon Creek Medical Center

Jacqueline Vuky
Ph: 503-299-6500

West Virginia
Charleston

West Virginia University Medical School - Charleston

Steven J. Jubelirer
Ph: 304-344-3457

Wisconsin
Burlington

Aurora Cancer Care-Burlington

Rubina Qamar
Ph: 888-709-2080

Elkhorn

Vince Lombardi Cancer Center at Aurora Lakeland Medical Center - Elkhorn

Rubina Qamar
Ph: 888-709-2080

Grafton

Aurora Cancer Care-Grafton

Rubina Qamar
Ph: 888-709-2080

Green Bay

St. Vincent Hospital Regional Cancer Center

Matthew L Ryan
Ph: 800-432-6049

Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center

Rubina Qamar
Ph: 888-709-2080

Janesville

Mercy Regional Cancer Center

Robert Delaune
Ph: 800-928-1103

Johnson Creek

UW Cancer Center Johnson Creek

Joshua M Lang
Ph: 877-405-6866

Kenosha

Oncology Alliance - Kenosha South

Rubina Qamar
Ph: 888-709-2080

La Crosse

Gundersen Lutheran Center for Cancer and Blood

Kurt Oettel
Ph: 608-775-2385
Email: cancerctr@gundluth.org

Madison

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Joshua M Lang
Ph: 877-405-6866

Marinette

Vince Lombardi Cancer Clinic - Marinette

Rubina Qamar
Ph: 888-709-2080

Menomonee Falls

Aurora Advanced Healthcare Inc-Menomonee Falls

Rubina Qamar
Ph: 888-709-2080

Milwaukee

Aurora Cancer Care-Milwaukee

Rubina Qamar
Ph: 888-709-2080

Aurora Sinai Medical Center

Rubina Qamar
Ph: 888-709-2080

Oncology Alliance, SC - Milwaukee - South

Rubina Qamar
Ph: 888-709-2080

New Richmond

Cancer Center of Western Wisconsin

Patrick J. Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Oshkosh

Vince Lombardi Cancer Clinic - Oshkosh

Rubina Qamar
Ph: 888-709-2080

Racine

Aurora Health Center - Racine

Rubina Qamar
Ph: 888-709-2080

Sheboygan

Vince Lombardi Cancer Clinic - Sheboygan

Rubina Qamar
Ph: 888-709-2080

Summit

Aurora Medical Center

Rubina Qamar
Ph: 888-709-2080

Two Rivers

Vince Lombardi Cancer Clinic - Two Rivers

Rubina Qamar
Ph: 888-709-2080

Waukesha

Aurora Cancer Care-Waukesha

Rubina Qamar
Ph: 888-709-2080

Wauwatosa

Oncology Alliance, SC - Milwaukee - West

Rubina Qamar
Ph: 888-709-2080

West Allis

Aurora Women's Pavilion of West Allis Memorial Hospital

Rubina Qamar
Ph: 888-709-2080

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01809691
ClinicalTrials.gov processed this data on February 16, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.