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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

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

Gilbert R. Carrizales, M.S.Ph: 614-8808 Ext.1027
  Email: gcarrizales@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
 Oklahoma University Cancer Institute
 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 Identifer NCT01809691
ClinicalTrials.gov processed this data on September 30, 2014

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.

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