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Tamoxifen Citrate in Treating Patients With Metastatic or Recurrent Breast Cancer

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, TreatmentActive18 and overNCI, OtherCDR0000672523
ECOG-E3108, E3108, NCT01124695

Trial Description

Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate may fight cancer by blocking the use of estrogen by tumor cells.

PURPOSE: This phase II trial is studying how well tamoxifen citrate works in patients with metastatic or recurrent breast cancer.

Further Study Information

OBJECTIVES:

Primary

  • To correlate CYP2D6 score (0 vs 1-2) and progression-free survival (PFS) of patients with metastatic breast cancer treated with tamoxifen citrate.

Secondary

  • To correlate CYP2D6 score (0 vs 1 vs 2) and PFS of patients treated with this regimen.
  • To correlate CYP2D6 score (0 vs 1 + 2) and the proportion of these patients who are PFS at 6 months.
  • To correlate endoxifen concentration with response in patients treated with this regimen.
  • To correlate CYP2D6 with response in patients treated with this regimen.
  • To correlate the presence of candidate estrogen receptor (ESR) 1 and 2 variant alleles, UGT7, SULT1A1, and other candidate genes to PFS.

OUTLINE: This is a multicenter study.

Patients receive oral tamoxifen citrate once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities.

Blood, plasma, and tissue samples are collected periodically for laboratory studies.

After completion of study therapy, patients are followed up every 3-6 months for 5 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the breast
  • Stage III (locally advanced), metastatic, or recurrent disease
  • Deemed not resectable
  • Estrogen-receptor and/or progesterone-receptor positive disease
  • Receptor status is based on most recent results
  • Receptor testing on metastatic disease is not required
  • Measurable or non-measurable disease
  • History of CNS metastasis allowed provided it has been treated (surgery, radiotherapy, or radiosurgery) within the past 4 weeks and does not require medications to control symptoms
  • No known leptomeningeal disease allowed

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Menopausal status not specified
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN if liver metastases present)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective nonhormonal contraception
  • No medical or psychiatric conditions that would interfere with protocol compliance, the ability to provide informed consent, assessment of response, or anticipated toxicities
  • More than 5 years since prior invasive malignancies except curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior investigational agents in the metastatic setting
  • Other prior investigational agents in any setting must have been completed at least 6 weeks prior to study registration and should be discussed with the study PI
  • Prior tamoxifen as adjuvant treatment is allowed as long as the patient did not have disease relapse or progression while on adjuvant tamoxifen or within 4 weeks of last dose
  • Prior tamoxifen for advanced disease is not allowed
  • No prior chemotherapy or trastuzumab (Herceptin) for metastatic disease
  • Prior chemotherapy, trastuzumab, or bevacizumab in the adjuvant setting allowed provided it has been completed ≥ 4 weeks before study therapy
  • Patients must not have had more than 2 lines of non-hormonal treatment in the locally advanced or metastatic setting, including trastuzumab (Herceptin), bevacizumab, or other biologics
  • Treatment in the advanced setting must have been completed at least 2 weeks prior to study initiation
  • Prior aromatase inhibitors (e.g., anastrozole, letrozole, exemestane, aminoglutethamide) are allowed in the adjuvant or metastatic setting
  • At least 2 weeks since prior and no concurrent medications that are strong to moderate inhibitors of CYP2D6 and may alter tamoxifen citrate metabolism including, but not limited to, any of the following:
  • Paroxetine (Paxil)
  • Fluoxetine (Prozac)
  • Bupropion (Wellbutrin)
  • Quinidine (Cardioquin)
  • Patients may not initiate bisphosphonate therapy while receiving treatment on this study
  • Patients who have begun receiving bisphosphonate therapy prior to registration may continue at the same intervals used prior to study registration
  • Concurrent radiotherapy to painful sites of bone disease or areas of impending fractures allowed provided the following criteria are met:
  • Radiotherapy was initiated before study entry
  • Sites of measurable or non-measurable disease are outside the radiotherapy port
  • Recovered from prior radiotherapy
  • No other concurrent hormonal therapy
  • No concurrent chemotherapy

Trial Contact Information

Trial Lead Organizations/Sponsors

Eastern Cooperative Oncology Group

National Cancer Institute

Vered StearnsPrincipal Investigator

Trial Sites

U.S.A.
Alabama
  Birmingham
 UAB Comprehensive Cancer Center
 Carla I. Falkson Ph: 205-934-0309
  Mobile
 University of South Alabama Mitchell Cancer Institute
 Windy Dean-Colomb Ph: 251-445-9870
  Email: pfrancisco@usouthal.edu
Arkansas
  Ft. Smith
 Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
 Tony A Flippin Ph: 800-378-9373
California
  Marysville
 Fremont-Rideout Cancer Center
 Helen K. Chew Ph: 916-734-3089
  Merced
 Mercy Cancer Center at Mercy Medical Center
 Prasad Pillai Ph: 916-734-3089
  Mountain View
 Palo Alto Medical Foundation
 Peter P. Yu Ph: 650-934-7000
  Orange
 St. Joseph Hospital Regional Cancer Center - Orange
 Sam S Huang Ph: 714-734-6220
  Palo Alto
 Palo Alto Medical Foundation
 David S Leibowitz Ph: 650-853-2906
  Email: waldorj@pamf.org
  Sacramento
 University of California Davis Cancer Center
 Helen K. Chew Ph: 916-734-3089
  Truckee
 Tahoe Forest Cancer Center
 Helen K. Chew Ph: 916-734-3089
Colorado
  Aurora
 Medical Center of Aurora - South Campus
 Eduardo R. Pajon Ph: 888-785-6789
  Boulder
 Boulder Community Hospital
 Eduardo R. Pajon Ph: 888-785-6789
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Eduardo R. Pajon Ph: 888-785-6789
  Denver
 CCOP - Colorado Cancer Research Program
 Eduardo R. Pajon Ph: 888-785-6789
 Porter Adventist Hospital
 Eduardo R. Pajon Ph: 888-785-6789
 Presbyterian - St. Luke's Medical Center
 Eduardo R. Pajon Ph: 888-785-6789
 Rose Medical Center
 Eduardo R. Pajon Ph: 888-785-6789
 St. Anthony Central Hospital
 Eduardo R. Pajon Ph: 888-785-6789
 St. Joseph Hospital
 Eduardo R. Pajon Ph: 888-785-6789
  Englewood
 Swedish Medical Center
 Eduardo R. Pajon Ph: 888-785-6789
  Greeley
 North Colorado Medical Center
 Eduardo R. Pajon Ph: 888-785-6789
  Littleton
 Littleton Adventist Hospital
 Eduardo R. Pajon Ph: 888-785-6789
  Lone Tree
 Sky Ridge Medical Center
 Eduardo R. Pajon Ph: 888-785-6789
  Longmont
 Hope Cancer Care Center at Longmont United Hospital
 Eduardo R. Pajon Ph: 888-785-6789
  Loveland
 McKee Medical Center
 Eduardo R. Pajon Ph: 888-785-6789
  Parker
 Parker Adventist Hospital
 Eduardo R. Pajon Ph: 888-785-6789
  Pueblo
 St. Mary - Corwin Regional Medical Center
 Eduardo R. Pajon Ph: 888-785-6789
  Wheat Ridge
 Exempla Lutheran Medical Center
 Eduardo R. Pajon Ph: 888-785-6789
Connecticut
  Middletown
 Middlesex Hospital Cancer Center
 Susanna Hong Ph: 860-358-2058
Delaware
  Lewes
 Tunnell Cancer Center at Beebe Medical Center
 Gregory A. Masters Ph: 302-733-6227
  Newark
 Helen F. Graham Cancer Center at Christiana Hospital
 Gregory A. Masters Ph: 302-733-6227
Florida
  Fort Lauderdale
 Broward General Medical Center Cancer Center
 Archana Maini Ph: 954-355-5346
  Hollywood
 Joe DiMaggio Children's Hospital
 Maricer Escalon Ph: 866-574-5124
  Email: Sylvester@emergingmed.com
Georgia
  Columbus
 John B. Amos Cancer Center
 Andrew W. Pippas Ph: 706-660-6404
  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
 Hawaii Medical Center - East
 Jeffrey L. Berenberg Ph: 808-586-2979
 Kapiolani Medical Center for Women and Children
 Jeffrey L. Berenberg Ph: 808-586-2979
 OnCare Hawaii, Incorporated - Kuakini
 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
 Straub Clinic and Hospital, Incorporated
 Jeffrey L. Berenberg Ph: 808-586-2979
  Lihue
 Kauai Medical Clinic
 Jeffrey L. Berenberg Ph: 808-586-2979
  Wailuku
 Maui Memorial Medical Center
 Jeffrey L. Berenberg Ph: 808-586-2979
 Pacific Cancer Institute - Maui
 Jeffrey L. Berenberg Ph: 808-586-2979
Illinois
  Chicago
 Louis A. Weiss Memorial Hospital
 Isoken Koko Ph: 708-488-0882
  Decatur
 Decatur Memorial Hospital Cancer Care Institute
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Elmhurst
 Elmhurst Memorial Hospital
 Lucio Di Nunno Ph: 630-782-7900
  River Forest
 West Suburban Center for Cancer Care
 Isoken Koko Ph: 708-488-0882
Indiana
  Elkhart
 Elkhart Clinic, LLC
 Jose A. Bufill Ph: 574-237-1328
 Elkhart General Hospital
 Jose A. Bufill Ph: 574-237-1328
 Michiana Hematology-Oncology, PC - Elkhart
 Jose A. Bufill Ph: 574-237-1328
  Indianapolis
 St. Francis Hospital Cancer Care Services
 Howard M. Gross Ph: 765-983-3000
  Kokomo
 Community Cancer Care at Howard Regional Health System
 Jose A. Bufill Ph: 574-237-1328
  La Porte
 Center for Cancer Therapy at LaPorte Hospital and Health Services
 Jose A. Bufill Ph: 574-237-1328
  Mishawaka
 Michiana Hematology-Oncology, PC - Mishawaka
 Jose A. Bufill Ph: 574-237-1328
 Saint Joseph's Medical Center
 Jose A. Bufill Ph: 574-237-1328
  Muncie
 Cancer Center at Ball Memorial Hospital
 Dejuania A Brown Ph: 765-751-5850
  Email: alpatterson@medicalconsultantspc.com
  Plymouth
 Michiana Hematology Oncology PC - Plymouth
 Jose A. Bufill Ph: 574-237-1328
  Richmond
 Reid Hospital & Health Care Services
 Howard M. Gross Ph: 317-783-8918
  South Bend
 CCOP - Northern Indiana CR Consortium
 Jose A. Bufill Ph: 574-237-1328
 Memorial Hospital of South Bend
 Jose A. Bufill Ph: 574-237-1328
 Michiana Hematology-Oncology, PC - South Bend
 Jose A. Bufill Ph: 574-237-1328
  Westville
 Michiana Hematology Oncology-PC Westville
 Jose A. Bufill Ph: 574-237-1328
Iowa
  Ames
 McFarland Clinic, PC
 Joseph James Merchant Ph: 515-239-2621
  Clive
 Medical Oncology and Hematology Associates-West Des Moines
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Mercy Cancer Center - West Lakes
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
  Des Moines
 CCOP - Iowa Oncology Research Association
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 John Stoddard Cancer Center at Iowa Lutheran Hospital
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 John Stoddard Cancer Center at Iowa Methodist Medical Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Medical Oncology and Hematology Associates at John Stoddard Cancer Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Medical Oncology and Hematology Associates at Mercy Cancer Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Mercy Cancer Center at Mercy Medical Center - Des Moines
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
  Sioux City
 Mercy Medical Center - Sioux City
 Donald Bruce Wender Ph: 712-252-0088
 Siouxland Hematology-Oncology Associates, LLP
 Donald Bruce Wender Ph: 712-252-0088
 St. Luke's Regional Medical Center
 Donald Bruce Wender Ph: 712-252-0088
  West Des Moines
 Methodist West Hospital
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
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
  Independence
 Cancer Center of Kansas-Independence
 Shaker R. Dakhil Ph: 316-262-4467
  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
  McPherson
 Cancer Center of Kansas, PA - McPherson
 Shaker R. Dakhil Ph: 316-262-4467
  Newton
 Cancer Center of Kansas, PA - Newton
 Shaker R. Dakhil Ph: 316-262-4467
  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
  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
Maryland
  Baltimore
 Greenebaum Cancer Center at University of Maryland Medical Center
 Katherine Tkaczuk Ph: 800-888-8823
 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 Vered Stearns Ph: 410-955-8804
  Email: jhcccro@jhmi.edu
  Elkton MD
 Union Hospital of Cecil County
 Gregory A. Masters Ph: 302-733-6227
Michigan
  Adrian
 Hickman Cancer Center at Bixby Medical Center
 Rex B Mowat Ph: 517-265-0116
 Rex B Mowat Ph: 517-265-0116
  Ann Arbor
 University of Michigan Comprehensive Cancer Center
 Anne F. Schott Ph: 800-865-1125
  Detroit
 Josephine Ford Cancer Center at Henry Ford Hospital
 Robert Anthony Chapman Ph: 313-916-1784
 Wayne State University
 Lawrence E. Flaherty Ph: 313-576-9363
  Escanaba
 Green Bay Oncology, Limited - Escanaba
 Gerald K. Bayer Ph: 800-432-6049
  Iron Mountain
 Green Bay Oncology - Iron Mountain
 Gerald K. Bayer Ph: 800-432-6049
  Kalamazoo
 Borgess Medical Center
 Raymond Sterling Lord Ph: 269-373-7458
 Bronson Methodist Hospital
 Raymond Sterling Lord Ph: 269-373-7458
 West Michigan Cancer Center
 Raymond Sterling Lord Ph: 269-373-7458
  Monroe
 Community Cancer Center of Monroe
 Rex B Mowat Ph: 517-265-0116
 Mercy Memorial Hospital - Monroe
 Rex B Mowat Ph: 517-265-0116
  Saint Joseph
 Lakeside Cancer Specialists, PLLC
 Jose A. Bufill Ph: 574-237-1328
  St. Joseph
 Lakeland Regional Cancer Care Center - St. Joseph
 Jose A. Bufill Ph: 574-237-1328
Minnesota
  Bemidji
 MeritCare Bemidji
 Preston D. Steen Ph: 701-234-6161
  Brainerd
 St. Joseph's Medical Center
 Daniel Nikcevich Ph: 888-203-7267
  Burnsville
 Fairview Ridges Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Coon Rapids
 Mercy and Unity Cancer Center at Mercy Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Duluth
 CCOP - Duluth
 Daniel Nikcevich Ph: 888-203-7267
 Essentia Health - Duluth Clinic
 Daniel Nikcevich Ph: 888-203-7267
 Miller - Dwan Medical Center
 Daniel Nikcevich Ph: 888-203-7267
  Edina
 Fairview Southdale Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Fridley
 Mercy and Unity Cancer Center at Unity Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Hutchinson
 Hutchinson Area Health Care
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Mankato
 Immanuel St. Joseph's
 Mohmmad J Ranginwala Ph: 507-385-2929
  Maplewood
 HealthEast Cancer Care at St. John's Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Minnesota Oncology - Maplewood
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Minneapolis
 Hennepin County Medical Center - Minneapolis
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  New Ulm
 New Ulm Medical Center
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Robbinsdale
 Humphrey Cancer Center at North Memorial Outpatient Center
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Rochester
 Mayo Clinic Cancer Center
 Matthew P. Goetz Ph: 507-538-7623
  Saint Louis Park
 CCOP - Metro-Minnesota
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Park Nicollet Cancer Center
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Saint Paul
 Regions Hospital Cancer Care Center
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 United Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Shakopee
 St. Francis Cancer Center at St. Francis Medical Center
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Stillwater
 Lakeview Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Waconia
 Ridgeview Medical Center
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Willmar
 Willmar Cancer Center at Rice Memorial Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Woodbury
 Minnesota Oncology - Woodbury
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
Mississippi
  Jackson
 University of Mississippi Cancer Clinic
 Barbara S Craft Ph: 601-815-6700
Missouri
  Bolivar
 Central Care Cancer Center at Carrie J. Babb Cancer Center
 Robert L Carolla Ph: 417-269-4520
  Branson
 Skaggs Cancer Center at Skaggs Regional Medical Center
 Robert L Carolla Ph: 417-269-4520
  Cape Girardeau
 Southeast Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
  Jefferson City
 Goldschmidt Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
  Rolla
 Mercy Clinic Cancer and Hematology - Rolla
 Robert L Carolla Ph: 417-269-4520
  Saint Louis
 Missouri Baptist Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
  Springfield
 Cancer Research for the Ozarks
 Robert L Carolla Ph: 417-269-4520
 Hulston Cancer Center at Cox Medical Center South
 Robert L Carolla Ph: 417-269-4520
 St. John's Regional Health Center
 Robert L Carolla Ph: 417-269-4520
Montana
  Billings
 Billings Clinic Cancer Center - 801 N 29th Street
 Benjamin Thomas Marchello Ph: 800-648-6274
 CCOP - Montana Cancer Consortium
 Benjamin Thomas Marchello Ph: 800-648-6274
 Hematology-Oncology Centers of the Northern Rockies - Billings
 Benjamin Thomas Marchello Ph: 800-648-6274
 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
 Benjamin Thomas Marchello Ph: 800-648-6274
  Butte
 St. James Healthcare Cancer Care
 Benjamin Thomas Marchello Ph: 800-648-6274
  Great Falls
 Benefis Sletten Cancer Institute
 Benjamin Thomas Marchello Ph: 800-648-6274
  Helena
 St. Peter's Hospital
 Benjamin Thomas Marchello Ph: 800-648-6274
  Kalispell
 Kalispell Regional Medical Center
 Benjamin Thomas Marchello Ph: 800-648-6274
  Missoula
 Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
 Benjamin Thomas Marchello Ph: 800-648-6274
 Montana Cancer Specialists at Montana Cancer Center
 Benjamin Thomas Marchello Ph: 800-648-6274
Nebraska
  Kearney
 Good Samaritan Cancer Center at Good Samaritan Hospital
 George K. Bascom Ph: 308-865-7963
  Lincoln
 Cancer Resource Center - Lincoln
 Gamini S. Soori Ph: 800-253-4368
  Omaha
 Alegant Health Cancer Center at Bergan Mercy Medical Center
 Gamini S. Soori Ph: 800-253-4368
 CCOP - Missouri Valley Cancer Consortium
 Gamini S. Soori Ph: 800-253-4368
 Creighton University Medical Center
 Gamini S. Soori Ph: 800-253-4368
 Immanuel Medical Center
 Gamini S. Soori Ph: 800-253-4368
 Lakeside Hospital
 Gamini S. Soori Ph: 800-253-4368
Nevada
  Las Vegas
 CCOP - Nevada Cancer Research Foundation
 John Allan Ellerton Ph: 702-731-8274
New Jersey
  Camden
 Cancer Institute of New Jersey at Cooper University Hospital - Camden
 Gregory A. Masters Ph: 302-733-6227
  Mount Holly
 Virtua Fox Chase Health Cancer Program at Virtua Memorial Hospital Burlington County
 Michael S. Entmacher Ph: 888-847-8823
  Paterson
 St. Joseph's Hospital and Medical Center
 Michael Maroules Ph: 973-754-2909
  Somerville
 Somerset Medical Center
 Kathleen C Toomey Ph: 908-685-2481
  Toms River
 J. Phillip Citta Regional Cancer Center at Community Medical Center
 Sudha Kavuru Ph: 732-818-3882
  Voorhees
 Fox Chase Virtua Health Cancer Program at Virtua West Jersey
 Michael S. Entmacher Ph: 888-847-8823
New Mexico
  Albuquerque
 Lovelace Medical Center - Downtown
 Melanie E. Royce Ph: 505-727-8000
 University of New Mexico Cancer Center
 Melanie E. Royce Ph: 505-727-8000
  Las Cruces
 Memorial Medical Center
 Melanie E. Royce Ph: 505-727-8000
New York
  Bronx
 Jack D. Weiler Hospital at Montefiore Medical Center - East Campus
 Christine M. Pellegrino Ph: 718-904-2730
  Email: aecc@aecom.yu.edu
 Montefiore Medical Center
 Christine M. Pellegrino Ph: 718-904-2730
  Email: aecc@aecom.yu.edu
  Glens Falls
 Charles R. Wood Cancer Center at Glens Falls Hospital
 Eric A Pillemer Ph: 518-926-6700
  New York
 Beth Israel Medical Center - Petrie Division
 Paula Klein Ph: 212-367-1729
 St. Luke's - Roosevelt Hospital Center - St.Luke's Division
 Paula Klein Ph: 212-367-1729
North Carolina
  Goldsboro
 Wayne Memorial Hospital, Incorporated
 James N. Atkins Ph: 919-580-0000
  Kinston
 Kinston Medical Specialists
 Peter R. Watson Ph: 252-559-2200
North Dakota
  Bismarck
 Medcenter One Hospital Cancer Care Center
 John T Reynolds Ph: 701-323-5760
  Email: tfischer@mohs.org
 Mid Dakota Clinic, PC
 John T Reynolds Ph: 701-323-5760
  Email: tfischer@mohs.org
 St. Alexius Medical Center Cancer Center
 John T Reynolds Ph: 701-323-5760
  Email: tfischer@mohs.org
  Fargo
 Roger Maris Cancer Center at MeritCare Hospital
 Miroslaw A Mazurczak Ph: 605-328-1367
 Preston D. Steen Ph: 701-234-6161
 Sanford Clinic North-Fargo
 Preston D. Steen Ph: 701-234-6161
Ohio
  Beachwood
 Cleveland Clinic Taussig Cancer Center
 Paula Silverman Ph: 800-641-2422
  Bowling Green
 Wood County Oncology Center
 Rex B Mowat Ph: 517-265-0116
  Canton
 Aultman Cancer Center at Aultman Hospital
 Kisa E Weeman Ph: 330-363-6891
  Cleveland
 Case Comprehensive Cancer Center
 Paula Silverman Ph: 800-641-2422
 Cleveland Clinic Cancer Center at Fairview Hospital
 Paula Silverman Ph: 800-641-2422
 Cleveland Clinic Taussig Cancer Center
 Paula Silverman Ph: 800-641-2422
  Dayton
 CCOP - Dayton
 Howard M. Gross Ph: 317-783-8918
 David L. Rike Cancer Center at Miami Valley Hospital
 Howard M. Gross Ph: 317-783-8918
 Good Samaritan Hospital
 Howard M. Gross Ph: 317-783-8918
 Grandview Hospital
 Howard M. Gross Ph: 317-783-8918
 Samaritan North Cancer Care Center
 Howard M. Gross Ph: 317-783-8918
  Elyria
 Hematology Oncology Center
 Rex B Mowat Ph: 517-265-0116
 Mercy Cancer Center - Elyria
 Rex B Mowat Ph: 517-265-0116
  Findlay
 Blanchard Valley Regional Cancer Center
 Howard M. Gross Ph: 317-783-8918
  Franklin
 Atrium Medical Center
 Howard M. Gross Ph: 317-783-8918
  Greenville
 Wayne Hospital
 Howard M. Gross Ph: 317-783-8918
  Independence
 Cleveland Clinic Taussig Cancer Center
 Paula Silverman Ph: 800-641-2422
  Kettering
 Charles F. Kettering Memorial Hospital
 Howard M. Gross Ph: 317-783-8918
  Lima
 Lima Memorial Hospital
 Rex B Mowat Ph: 517-265-0116
  Maumee
 Northwest Ohio Oncology Center
 Rex B Mowat Ph: 517-265-0116
 Rex B Mowat Ph: 517-265-0116
  Mayfield Heights
 Hillcrest Cancer Center at Hillcrest Hospital
 Paula Silverman Ph: 800-641-2422
  Oregon
 St. Charles Mercy Hospital
 Rex B Mowat Ph: 517-265-0116
 Toledo Clinic - Oregon
 Rex B Mowat Ph: 517-265-0116
  Parma
 Parma Community General Hospital
 Anjali S Advani Ph: 866-223-8100
  Sandusky
 North Coast Cancer Care, Incorporated
 Paula Silverman Ph: 800-641-2422
  Strongsville
 Cleveland Clinic Foundation - Strongsville
 Anjali S Advani Ph: 866-223-8100
  Sylvania
 Flower Hospital Cancer Center
 Rex B Mowat Ph: 517-265-0116
  Tiffin
 Mercy Hospital of Tiffin
 Rex B Mowat Ph: 517-265-0116
  Toledo
 CCOP - Toledo Community Hospital
 Rex B Mowat Ph: 517-265-0116
 St. Anne Mercy Hospital
 Rex B Mowat Ph: 517-265-0116
 St. Vincent Mercy Medical Center
 Rex B Mowat Ph: 517-265-0116
 Toledo Clinic, Incorporated - Main Clinic
 Rex B Mowat Ph: 517-265-0116
 Toledo Hospital
 Rex B Mowat Ph: 517-265-0116
 University of Toledo Medical Center
 Rex B Mowat Ph: 517-265-0116
  Troy
 UVMC Cancer Care Center at Upper Valley Medical Center
 Howard M. Gross Ph: 317-783-8918
  Wauseon
 Fulton County Health Center
 Rex B Mowat Ph: 517-265-0116
  Wooster
 Cleveland Clinic - Wooster
 Paula Silverman Ph: 800-641-2422
  Wright-Patterson Afb
 United States Air Force Medical Center - Wright-Patterson
 Brandon J Cutler Ph: 937-257-1398
  Xenia
 Ruth G. McMillan Cancer Center at Greene Memorial Hospital
 Howard M. Gross Ph: 317-783-8918
Oklahoma
  Norman
 Cancer Care Associates - Norman
 Vikki Ann Canfield Ph: 888-823-5923
  Email: ctsucontact@westat.com
  Oklahoma City
 Cancer Care Associates - Mercy Campus
 Vikki Ann Canfield Ph: 888-823-5923
  Email: ctsucontact@westat.com
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
 Leah v Cream Ph: 717-531-3779
  Email: CTO@hmc.psu.edu
  Langhorne
 St. Mary Regional Cancer Center
 Robert C. Reilly Ph: 215-710-4585
  Pottstown
 Pottstown Memorial Regional Cancer Center
 Wei Song Ph: 610-327-7544
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
Texas
  Dallas
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 Barbara B. Haley Ph: 214-648-7097
Virginia
  Fredericksburg
 Fredericksburg Oncology Inc
 Rex B Mowat Ph: 517-265-0116
Washington
  Anacortes
 Cancer Care Center at Island Hogs
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
  Bellingham
 St. Joseph Cancer Center
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
  Bremerton
 Olympic Hematology and Oncology
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
  Burien
 Highline Medical Center Cancer Center
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
  Edmonds
 Swedish Cancer Institute at Stevens Hospital
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
  Issaquah
 Swedish Medical Center - Issaquah Campus
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
  Kennewick
 Columbia Basin Hematology
 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
  Poulsbo
 Harrison Poulsbo Hematology and Onocology
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
  Seattle
 Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
 Group Health Central Hospital
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
 Harborview Medical Center
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
 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
 University Cancer Center at University of Washington Medical Center
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
  Sedro-Woolley
 North Puget Oncology at United General Hospital
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
  Spokane
 Cancer Care Northwest - Spokane South
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
 Evergreen Hematology and Oncology, PS
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
  Wenatchee
 Wenatchee Valley Medical Center
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
West Virginia
  Charleston
 West Virginia University Medical School - Charleston
 Steven J. Jubelirer Ph: 304-388-9944
Wisconsin
  Antigo
 Langlade Memorial Hospital
 Hamied R. Rezazadeh Ph: 877-405-6866
  Green Bay
 Green Bay Oncology, Limited at St. Mary's Hospital
 Gerald K. Bayer Ph: 800-432-6049
 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
 Gerald K. Bayer Ph: 800-432-6049
 St. Mary's Hospital Medical Center - Green Bay
 Gerald K. Bayer Ph: 800-432-6049
 St. Vincent Hospital Regional Cancer Center
 Gerald K. Bayer Ph: 800-432-6049
 Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
 Dhimant R. Patel Ph: 800-252-2990
  La Crosse
 Gundersen Lutheran Center for Cancer and Blood
 Kurt Oettel Ph: 608-775-2385
  Email: cancerctr@gundluth.org
  Manitowoc
 Holy Family Memorial Medical Center Cancer Care Center
 Gerald K. Bayer Ph: 800-432-6049
  Marinette
 Bay Area Cancer Care Center at Bay Area Medical Center
 Gerald K. Bayer Ph: 800-432-6049
 Vince Lombardi Cancer Clinic - Marinette
 Dhimant R. Patel Ph: 800-252-2990
  Mukwonago
 D.N. Greenwald Center
 Michael A Thompson Ph: 262-928-7632
  New Richmond
 Cancer Center of Western Wisconsin
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Oconomowoc
 Regional Cancer Center at Oconomowoc Memorial Hospital
 Michael A Thompson Ph: 262-928-7632
  Oconto Falls
 Green Bay Oncology, Limited - Oconto Falls
 Gerald K. Bayer Ph: 800-432-6049
  Oshkosh
 Vince Lombardi Cancer Clinic - Oshkosh
 Dhimant R. Patel Ph: 800-252-2990
  Sheboygan
 Saint Nicholas Hospital
 Gerald K. Bayer Ph: 800-432-6049
 Vince Lombardi Cancer Clinic - Sheboygan
 Dhimant R. Patel Ph: 800-252-2990
  Sturgeon Bay
 Green Bay Oncology, Limited - Sturgeon Bay
 Gerald K. Bayer Ph: 800-432-6049
  Summit
 Aurora Medical Center
 Dhimant R. Patel Ph: 800-252-2990
  Two Rivers
 Vince Lombardi Cancer Clinic - Two Rivers
 Dhimant R. Patel Ph: 800-252-2990
  Waukesha
 Waukesha Memorial Hospital Regional Cancer Center
 Michael A Thompson Ph: 262-928-7632
  Wausau
 University of Wisconcin Cancer Center at Aspirus Wausau Hospital
 Hamied R. Rezazadeh Ph: 877-405-6866
  Wisconsin Rapids
 Riverview UW Cancer Center at Riverview Hospital
 Ron James Kirschling Ph: 877-405-6866
Wyoming
  Casper
 Rocky Mountain Oncology
 Benjamin Thomas Marchello Ph: 800-648-6274
  Sheridan
 Welch Cancer Center at Sheridan Memorial Hospital
 Benjamin Thomas Marchello Ph: 800-648-6274
Canada
British Columbia
  Kelowna
 British Columbia Cancer Agency - Centre for the Southern Interior
 Caroline A Lohrisch Ph: 888-939-3333
  Vancouver
 British Columbia Cancer Agency - Vancouver Cancer Centre
 Caroline A Lohrisch Ph: 888-939-3333
Peru
  Lima
 Instituto Nacional de Enfermedades Neoplasicas
 Henry L Gomez Moreno Ph: (511) 710-6900

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01124695
Information obtained from ClinicalTrials.gov on December 09, 2012

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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