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S0812 High Dose Cholecalciferol in Premenopausal Women at High-Risk for 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, PreventionActive18 to 50NCI, OtherS0812
U10CA037429, NCI-2011-02032, SWOG-S0812, NCT01097278

Trial Description

Summary

RATIONALE: Cholecalciferol may prevent breast cancer in premenopausal women.

PURPOSE: This randomized phase II trial is studying how well cholecalciferol works in preventing breast cancer in premenopausal women.

Further Study Information

OBJECTIVES:

  • To assess whether mammographic density is reduced in premenopausal women at high risk of breast cancer taking high-dose vitamin D3 (oral cholecalciferol 20,000 IU weekly) vs placebo for 1 year.
  • To assess whether proliferation as measured by Ki-67 staining of breast epithelial cells is reduced in women receiving these treatments.
  • To explore the difference in the expression of other biomarkers (including cleaved caspase-3 [apoptosis marker], ER, vitamin D receptor [VDR], and 1α-hydroxylase) in breast tissue obtained from these women.
  • To assess whether parathyroid hormone, IGF-1, IGFBP-3, 25(OH)D, and 1,25(OH)D serum levels are altered in these women at baseline and at 6 and 12 months.
  • To explore whether a change in mammographic density correlates with polymorphisms in the VDR gene.
  • To assess other sources of vitamin D (sunlight exposure, diet) in these women using a validated questionnaire administered at baseline and at 12 and 24 months.
  • To collect and bank serum, plasma, and breast tissue from these women before and after a 1-year intervention with vitamin D for future biomarker analysis.
  • To assess the toxicity of high-dose cholecalciferol compared to placebo in this setting.

OUTLINE: This is a multicenter study. Participants are stratified according to baseline serum 25(OH)D level (< 20 ng/mL vs 20-32 ng/mL or < 50 nmol/L vs 50-80 nmol/L), baseline mammographic density (11-50% vs > 50%), and designated biopsy site (yes vs no). Participants are randomized to 1 of 2 treatment arms.

  • Arm I: Participants receive oral cholecalciferol once weekly and oral vitamin D once daily. Treatment repeats for 12 months in the absence of evidence of cancer or unacceptable toxicity.
  • Arm II: Participants receive oral placebo once weekly and oral vitamin D once daily. Treatment repeats for 12 months in the absence of evidence of cancer or unacceptable toxicity.

Blood samples are collected at baseline and periodically thereafter for biomarkers and 25(OH)D level. Participants undergo a mammogram at baseline and at 12 months. Participants may also undergo random core-needle breast biopsy at baseline and at 12 months.

Participants complete a questionnaire at baseline and at 12 and 24 months.

After completion of study therapy, participants are followed up at 1 and 12 months.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • At an elevated risk of breast cancer by at least one of the following criteria:
  • Diagnosis of ADH, ALH, lobular carcinoma in situ (LCIS) or resected ductal carcinoma in situ (DCIS) or small invasive breast cancers (pTmi or pT1a N0) if no pior RT, tamoxifen, or systemic breast cancer treatment within 28 days prior to registration OR diagnosis of resected Stage I (T1b-c N0-N1mi) through Stage II breast cancer for which the participant has been disease-free for at least 5 years and has completed all adjuvant treatment OR
  • A known* deleterious mutation in BRCA1, BRCA2, PTEN, or TP53 NOTE: *The participant must be a documented carrier to meet this criterion. If there is a known mutation in a hereditary breast cancer susceptibility gene in a participant's family member, the participant herself must have undergone genetic testing as per NCCN clinical guidelines to be eligible per this criterion.
  • Modified Gail Model/CARE model** risk at 5 years ≥ 1.67% or lifetime risk ≥ 20% by Claus, BRCAPro, Tyrer-Cuzick or IBIS models OR
  • Mammographic density ≥ 50% (heterogenously dense) NOTE: **Risk models are to be used only if there is no known previous diagnosis of resected DCIS or LCIS and there is no known deleterious mutation in BRCA1, BRCA2, PTEN, or TP53.
  • At least one breast available for imaging and biopsy (a previously irradiated breast [i.e., for resected DCIS] is not evaluable for breast imaging or biopsy)
  • Baseline mammogram (performed within 10 days after starting their last menstrual period on a digital mammography machine) that shows either normal or benign findings
  • Baseline mammographic density > 10% based upon the classification system (2 = 11-50%, "scattered fibroglandular densities"; 3 = 51-75%, "heterogeneously dense"; 4 = >75, "extremely dense". Women with a baseline mammographic density of ≤ 10% (1 = ≤ 10% breasts are almost entirely fat)will not be eligible.

PATIENT CHARACTERISTICS:

  • Premenopausal, defined as ≥ 1 of the following criteria:
  • Less than 6 months since the last menstrual period, no prior bilateral oophorectomy, and no use of hormone-replacement therapy
  • Has undergone a prior hysterectomy but no prior bilateral oophorectomy AND follicle-stimulating hormone values measured within the past 28 days are consistent with the normal values for the premenopausal state
  • Zubrod performance status 0-1
  • Serum creatinine ≤ upper limit of normal (ULN)
  • Serum calcium or corrected calcium ≤ ULN
  • Spot urine calcium:creatinine ratio < 0.37 mg/dL
  • INR ≤ 1.5 times ULN+
  • PT and PTT ≤ ULN*
  • Baseline serum 25(OH)D level ≤ 32 ng/mL (or 80 nmol/L)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other prior malignancy except for the following:
  • Adequately treated basal cell or squamous cell skin cancer
  • In situ cervical cancer
  • Adequately treated stage I or II (including resected Stage I, T1b-c N0-N1mi through Stage II breast cancer) from which the participant is currently in complete remission
  • Any other cancer (including contralateral breast) for which the participant has been disease-free for ≥ 5 years
  • No history of kidney stones
  • No medical conditions requiring calcium or vitamin D supplementation (i.e., osteoporosis)
  • No known hypersensitivity to vitamin D
  • No known allergy to soy NOTE: +For patients undergoing breast biopsy.

PRIOR CONCURRENT THERAPY:

  • Prior breast reduction surgery allowed
  • No bilateral breast implants
  • More than 1 month since prior surgery or radiotherapy to the breast for resected DCIS
  • At least 28 days since prior tamoxifen
  • Prior anticoagulant therapy allowed provided it is discontinued ≥ 7 days before breast biopsy
  • No concurrent calcium or additional vitamin D supplements
  • Concurrent multivitamins allowed provided that the dose of vitamin D in the multivitamin does not exceed 400 IU daily
  • No concurrent participation in any other clinical trial for the treatment or prevention of cancer unless the participant is no longer receiving the intervention and is in the follow-up phase only (participants must not join such a trial while participating in this study)

Trial Contact Information

Trial Lead Organizations/Sponsors

Southwest Oncology Group

National Cancer Institute

Katherine D. Crew, MD, MSPrincipal Investigator

Patricia O'KanePh: 2106148808 Ext.1011
  Email: pokane@swog.org

Trial Sites

U.S.A.
Alabama
  Anniston
 Regional Medical Center
 George I Crawford Ph: 256-235-5084
  Mobile
 Providence Cancer Center at Providence Hospital
 Thaddeus A Beeker Ph: 877-904-4367
Arizona
  Tucson
 Arizona Cancer Center at University Medical Center North
 Joanne M Jeter Ph: 520-626-9008
 Arizona Cancer Center at University of Arizona Health Sciences Center
 Joanne M Jeter Ph: 520-626-9008
Arkansas
  Rogers
 Highlands Oncology Group - Bentonville
 Joseph Thaddeus Beck Ph: 800-381-6939
California
  Castro Valley
 East Bay Radiation Oncology Center
 James H. Feusner Ph: 510-450-7600
  Concord
 Cancer Care Center at John Muir Health - Concord Campus
 Deborah L. Kerlin Ph: 925-674-2580
  Costa Mesa
 UC Irvine Health Pacific Breast Care Center
 David Hsiang Ph: 877-827-8839
  Email: ucstudy@uci.edu
  Dublin
 Epic Care-Dublin
 James H. Feusner Ph: 510-450-7600
  Long Beach
 Breastlink Medical Group, Incorporated at Long Beach Memorial Medical Center
 John S. Link Ph: 562-981-6101
  Los Angeles
 USC/Norris Comprehensive Cancer Center and Hospital
 Agustin Garcia Ph: 323-865-0451
 Agustin Garcia Ph: 323-865-0451
  Martinez
 Contra Costa Regional Medical Center
 James H. Feusner Ph: 510-450-7600
  Mountain View
 El Camino Hospital Cancer Center
 James H. Feusner Ph: 510-450-7600
  Oakland
 Alta Bates Summit Medical Center - Summit Campus
 James H. Feusner Ph: 510-450-7600
 Bay Area Breast Surgeons, Incorporated
 James H. Feusner Ph: 510-450-7600
 CCOP - Bay Area Tumor Institute
 James H. Feusner Ph: 510-450-7600
 Epic Care - Oakland
 James H. Feusner Ph: 510-450-7600
 Highland General Hospital
 James H. Feusner Ph: 510-450-7600
 Larry G Strieff MD Medical Corporation
 James H. Feusner Ph: 510-450-7600
  Orange
 Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
 David Hsiang Ph: 877-827-8839
  Email: ucstudy@uci.edu
  Pasadena
 Huntington OutPatient Surgery Center
 Jeannie Shen Ph: 626-535-2420
  Pleasant Hill
 East Bay Medical Oncology Hematology Associates - Pleasant Hill
 James H. Feusner Ph: 510-450-7600
  Pleasanton
 Valley Medical Oncology Consultants - Pleasanton
 James H. Feusner Ph: 510-450-7600
  San Pablo
 Doctors Medical Center - San Pablo Campus
 James H. Feusner Ph: 510-450-7600
  Walnut Creek
 John Muir/Mt. Diablo Comprehensive Cancer Center
 Deborah L. Kerlin Ph: 925-674-2580
  Whittier
 Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital
 Dustin E Stevenson Ph: 562-698-0811
Colorado
  Aurora
 Medical Center of Aurora - South Campus
 Keren Sturtz Ph: 888-785-6789
  Boulder
 Boulder Community Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers-Boulder
 Keren Sturtz Ph: 888-785-6789
  Colorado Springs
 Memorial Hospital Cancer Center - Colorado Springs
 Laura K Pomerenke Ph: 888-785-6789
 Penrose Cancer Center at Penrose Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers at the Pavilion
 Keren Sturtz Ph: 888-785-6789
  Denver
 CCOP - Colorado Cancer Research Program
 Keren Sturtz Ph: 888-785-6789
 Colorado Blood Cancer Institute
 Keren Sturtz Ph: 888-785-6789
 Porter Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Presbyterian - St. Luke's Medical Center
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Denver Midtown
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers-Rose
 Keren Sturtz Ph: 888-785-6789
 Rose Medical Center
 Keren Sturtz Ph: 888-785-6789
 St. Joseph Hospital
 Keren Sturtz Ph: 888-785-6789
  Durango
 Mercy Medical Center
 Keren Sturtz Ph: 888-785-6789
  Englewood
 Comprehensive Cancer Care and Research Institute of Colorado LLC
 Keren Sturtz Ph: 888-785-6789
 Swedish Medical Center
 Keren Sturtz Ph: 888-785-6789
  Fort Collins
 Poudre Valley Hospital
 Regina J Brown Ph: 970-495-8226
  Golden
 Mountain Blue Cancer Care Center
 Keren Sturtz Ph: 888-785-6789
  Greeley
 North Colorado Medical Center
 Keren Sturtz Ph: 888-785-6789
  Greenwood Village
 Breast Cancer Care Consultants
 Keren Sturtz Ph: 888-785-6789
  Lakewood
 Rocky Mountain Cancer Centers-Lakewood
 Keren Sturtz Ph: 888-785-6789
 St. Anthony Central Hospital
 Keren Sturtz Ph: 888-785-6789
  Littleton
 Littleton Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
  Lone Tree
 Rocky Mountain Cancer Centers - Lone Tree
 Keren Sturtz Ph: 888-785-6789
 Sky Ridge Medical Center
 Keren Sturtz Ph: 888-785-6789
  Longmont
 Hope Cancer Care Center at Longmont United Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Longmont
 Keren Sturtz Ph: 888-785-6789
  Loveland
 McKee Medical Center
 Keren Sturtz Ph: 888-785-6789
  Parker
 Parker Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Parker
 Keren Sturtz Ph: 888-785-6789
  Pueblo
 Rocky Mountain Cancer Centers - Pueblo
 Keren Sturtz Ph: 888-785-6789
 St. Mary - Corwin Regional Medical Center
 Keren Sturtz Ph: 888-785-6789
  Wheat Ridge
 Exempla Lutheran Medical Center
 Keren Sturtz Ph: 888-785-6789
Connecticut
  Greenwich
 Bendheim Cancer Center at Greenwich Hospital
 Laura Lazarus Ph: 203-863-3698
  Hartford
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Philip J. Stella Ph: 734-712-3456
  Middletown
 Middlesex Hospital Cancer Center
 Susanna Hong Ph: 860-358-2058
Florida
  Orlando
 Florida Hospital Cancer Institute at Florida Hospital Orlando
 Lee M. Zehngebot Ph: 407-303-5623
  Stuart
 Robert and Carol Weissman Cancer Center at Martin Memorial
 James J. Vopal Ph: 772-288-5858ext4
 James J. Vopal Ph: 772-288-5858ext4
 James J. Vopal Ph: 772-288-5858ext4
Georgia
  Decatur
 Charles B. Eberhart Cancer Center at DeKalb Medical Center
 Jayanthi Srinivasiah Ph: 404-501-3279
Hawaii
  Aiea
 Kapiolani Medical Center at Pali Momi
 Jeffrey L. Berenberg Ph: 808-586-2979
 Jeffrey L. Berenberg Ph: 808-586-2979
  Honolulu
 Cancer Research Center of Hawaii
 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
 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
 Tripler Army Medical Center
 Jeffrey L. Berenberg Ph: 808-586-2979
  Kailua
 Castle Medical Center
 Jeffrey L. Berenberg Ph: 808-586-2979
  Lihue
 Kauai Medical Clinic
 Jeffrey L. Berenberg Ph: 808-586-2979
Idaho
  Boise
 Mountain States Tumor Institute at St. Luke's Regional Medical Center
 Paul G. Montgomery Ph: 800-845-4624
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Philip J. Stella Ph: 734-712-3456
  Meridian
 Mountain States Tumor Institute - Meridian
 Paul G. Montgomery Ph: 800-845-4624
  Post Falls
 Kootenai Cancer Center - Post Falls
 Benjamin Thomas Marchello Ph: 800-648-6274
  Twin Falls
 Mountain States Tumor Institute at St. Luke's
 Paul G. Montgomery Ph: 800-845-4624
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
  Decatur
 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
  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
  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
  Monmouth
 Illinois CancerCare - Monmouth
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Mount Vernon
 Good Samaritan Regional Health Center
 Jay W Carlson Ph: 888-244-6061
  Email: sherrijr@iora.org
  Normal
 Community Cancer Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Ottawa
 Community Hospital of Ottawa
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 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
 CCOP - Illinois Oncology Research Association
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 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
  Springfield
 Regional Cancer Center at Memorial Medical Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Warrenville
 Central Dupage Cancer Center
 John D Ayers Ph: 630-352-5300
Indiana
  Elkhart
 Elkhart Clinic, LLC
 Robin Zon Ph: 574-234-5123
 Elkhart General Hospital
 Robin Zon Ph: 574-234-5123
 Michiana Hematology-Oncology, PC - Elkhart
 Robin Zon Ph: 574-234-5123
  Indianapolis
 Indiana University Melvin and Bren Simon Cancer Center
 Lida A Mina Ph: 317-274-2552
  Kokomo
 Community Cancer Care at Howard Regional Health System
 Robin Zon Ph: 574-234-5123
  La Porte
 Center for Cancer Therapy at LaPorte Hospital and Health Services
 Robin Zon Ph: 574-234-5123
  Mishawaka
 Michiana Hematology-Oncology, PC - Mishawaka
 Robin Zon Ph: 574-234-5123
 Saint Joseph's Medical Center
 Robin Zon Ph: 574-234-5123
  Plymouth
 Michiana Hematology Oncology PC - Plymouth
 Robin Zon Ph: 574-234-5123
  South Bend
 CCOP - Northern Indiana CR Consortium
 Robin Zon Ph: 574-234-5123
 Memorial Hospital of South Bend
 Robin Zon Ph: 574-234-5123
 Michiana Hematology-Oncology, PC - South Bend
 Robin Zon Ph: 574-234-5123
 South Bend Clinic
 Robin Zon Ph: 574-234-5123
  Westville
 Michiana Hematology Oncology-PC Westville
 Robin Zon Ph: 574-234-5123
Iowa
  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
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
  Manhattan
 Cancer Center of Kansas-Manhattan
 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
  Overland Park
 Menorah Medical Center
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
 Saint Luke's Hospital - South
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
  Parsons
 Cancer Center of Kansas, PA - Parsons
 Shaker R. Dakhil Ph: 316-262-4467
  Prairie Village
 CCOP - Kansas City
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
  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
Kentucky
  Corbin
 Baptist Regional Medical Center
 Elvis S Donaldson Ph: 859-260-6425
  Lexington
 Central Baptist Hospital
 Elvis S Donaldson Ph: 859-260-6425
Louisiana
  Baton Rouge
 Hematology-Oncology Clinic
 Hana F Safah Ph: 504-988-6121
  New Orleans
 Ochsner Cancer Institute at Ochsner Clinic Foundation
 John T Cole Ph: 888-562-4763
 Tulane Cancer Center at Tulane University Hospital and Clinic
 Hana F Safah Ph: 504-988-6121
Massachusetts
  Brighton
 Caritas St. Elizabeth's Medical Center
 Dorcas D Chi Ph: 617-789-2903
  Burlington
 Lahey Clinic Medical Center - Burlington
 Corrine L Zarwan Ph: 781-744-8027
Michigan
  Ann Arbor
 CCOP - Michigan Cancer Research Consortium
 Philip J. Stella Ph: 734-712-3456
 Saint Joseph Mercy Cancer Center
 Philip J. Stella Ph: 734-712-3456
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Philip J. Stella Ph: 734-712-3456
  Detroit
 Josephine Ford Cancer Center at Henry Ford Hospital
 Robert Anthony Chapman Ph: 313-916-1784
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Philip J. Stella Ph: 734-712-3456
 Wayne State University
 Sayeh M Lavasani Ph: 313-576-9363
  Farmington
 Botsford Oncology Practice at Botsford General Hospital
 Padmaja V Venuturumilli Ph: 248-551-7695
  Flint
 Genesys Hurley Cancer Institute
 Philip J. Stella Ph: 734-712-3456
 Philip J. Stella Ph: 734-712-3456
 Hurley Medical Center
 Philip J. Stella Ph: 734-712-3456
  Jackson
 Gayle M. Jacob Cancer Center at Allegiance Health
 Philip J. Stella Ph: 734-712-3456
  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
  Lansing
 Sparrow Regional Cancer Center
 Philip J. Stella Ph: 734-712-3456
  Livonia
 St. Mary Mercy Hospital
 Philip J. Stella Ph: 734-712-3456
  Midland
 MidMichigan Medical Center - Midland
 Michel R. Hurtubise Ph: 989-839-3377
  Pontiac
 St. Joseph Mercy Oakland
 Philip J. Stella Ph: 734-712-3456
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Philip J. Stella Ph: 734-712-3456
  Royal Oak
 William Beaumont Hospital - Royal Oak Campus
 Padmaja V Venuturumilli Ph: 248-551-7695
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Philip J. Stella Ph: 734-712-3456
  Saint Joseph
 Lakeside Cancer Specialists, PLLC
 Robin Zon Ph: 574-234-5123
  St. Joseph
 Lakeland Regional Cancer Care Center - St. Joseph
 Robin Zon Ph: 574-234-5123
  Troy
 William Beaumont Hospital - Troy Campus
 Padmaja V Venuturumilli Ph: 248-551-7695
  Warren
 St. John Macomb Hospital
 Philip J. Stella Ph: 734-712-3456
Minnesota
  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
  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
  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
  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
  Pascagoula
 Regional Cancer Center at Singing River Hospital
 James E. Clarkson Ph: 228-809-5292
Missouri
  Bolivar
 Central Care Cancer Center at Carrie J. Babb Cancer Center
 Jay W Carlson Ph: 888-244-6061
  Email: sherrijr@iora.org
  Cape Girardeau
 Saint Francis Medical Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Independence
 Independence Regional Health Center
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
  Joplin
 St. John's Regional Medical Center
 Jay W Carlson Ph: 888-244-6061
  Email: sherrijr@iora.org
  Kansas City
 Heartland Hematology Oncology Associates, Incorporated
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
 Research Medical Center
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
 Saint Luke's Hospital
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
  Lee's Summit
 Saint Luke's East - Lee's Summit
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
  Liberty
 Parvin Radiation Oncology
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
  Rolla
 Mercy Clinic Cancer and Hematology - Rolla
 Robert L Carolla Ph: 417-269-4520
  Saint Joseph
 Heartland Regional Medical Center
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
 Saint Joseph Oncology, Incorporated
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
  Saint Louis
 David C. Pratt Cancer Center at St. John's Mercy
 Bethany G. Sleckman Ph: 913-948-5588
 Mercy Clinic St. Louis Cancer and Breast Institute
 Bethany G. Sleckman Ph: 913-948-5588
  Springfield
 Cancer Research for the Ozarks
 Robert L Carolla Ph: 417-269-4520
 Hulston Cancer Center at Cox Medical Center South
 Jay W Carlson Ph: 888-244-6061
  Email: sherrijr@iora.org
 St. John's Regional Health Center
 Jay W Carlson Ph: 888-244-6061
  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
 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
  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
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: 402-280-4100
  Omaha
 Alegant Health Cancer Center at Bergan Mercy Medical Center
 Gamini S. Soori Ph: 402-280-4100
 CCOP - Missouri Valley Cancer Consortium
 Gamini S. Soori Ph: 402-280-4100
 Creighton University Medical Center
 Gamini S. Soori Ph: 402-280-4100
 Immanuel Medical Center
 Gamini S. Soori Ph: 402-280-4100
 Lakeside Hospital
 Gamini S. Soori Ph: 402-280-4100
New Hampshire
  Nashua
 Oncology Center at St. Joseph Hospital
 Mary Ann Voltz Ph: 603-880-3408
  Email: carcieri@sjh-nh.org
New Jersey
  Vineland
 Frank and Edith Scarpa Regional Cancer Pavillion at South Jersey Healthcare
 Shailja Roy Ph: 856-641-7933
New Mexico
  Albuquerque
 Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital
 Melanie E. Royce Ph: 505-727-8000
New York
  East Syracuse
 CCOP - Hematology-Oncology Associates of Central New York
 Jeffrey J. Kirshner Ph: 315-472-7504
  Mineola
 Winthrop University Hospital
 Nina D'Abreo Ph: 866-946-8476
  New York
 Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
 Katherine D Crew Ph: 212-305-8615
  Rochester
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Jonathan W Friedberg Ph: 585-275-5830
  Syracuse
 SUNY Upstate Medical University Hospital
 Jayne R Charlamb Ph: 315-464-5476
North Carolina
  Asheboro
 Randolph Hospital
 Peter Rubin Ph: 336-832-0821
  Charlotte
 Presbyterian Cancer Center at Presbyterian Hospital
 Justin P Favaro Ph: 704-384-5369
  Greensboro
 Moses Cone Regional Cancer Center at Wesley Long Community Hospital
 Peter Rubin Ph: 336-832-0821
  Hendersonville
 Comprehensive Cancer Center at Pardee Hospital
 James E. Radford Ph: 828-696-4716
 Park Ridge Hospital Breast Health Center
 James Dewitt Bearden Ph: 800-486-5941
  Reidsville
 Annie Penn Cancer Center
 Peter Rubin Ph: 336-832-0821
North Dakota
  Minot
 Trinity CancerCare Center
 Stephen N Makoni Ph: 800-862-0005
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
  Belpre
 Strecker Cancer Center-Belpre
 J. Philip Kuebler Ph: 614-566-3275
  Chillicothe
 Adena Regional Medical Center
 J. Philip Kuebler Ph: 614-566-3275
  Columbus
 CCOP - Columbus
 J. Philip Kuebler Ph: 614-566-3275
 Columbus Oncology Associates, Incorporated
 J. Philip Kuebler Ph: 614-566-3275
 Doctors Hospital at Ohio Health
 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
  Delaware
 Delaware Health Center
 J. Philip Kuebler Ph: 614-566-3275
 Grady Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Lancaster
 Fairfield Medical Center
 J. Philip Kuebler Ph: 614-566-3275
  Marietta
 Strecker Cancer Center at Marietta Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Medina
 Summa Health Center at Lake Medina
 Jennifer E Payne Ph: 330-375-6101
  Mount Vernon
 Knox Community Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Newark
 Licking Memorial Cancer Care Program at Licking 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
  Westerville
 Mount Carmel St. Ann's Cancer Center
 J. Philip Kuebler Ph: 614-566-3275
  Zanesville
 Genesis - Good Samaritan Hospital
 J. Philip Kuebler Ph: 614-566-3275
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 William C Dooley Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Oregon
  Clackamas
 Clackamas Radiation Oncology Center
 Alison K Conlin Ph: 503-215-6412
  Milwaukie
 Providence Milwaukie Hospital
 Alison K Conlin Ph: 503-215-6412
  Newberg
 Providence Newberg Medical Center
 Alison K Conlin Ph: 503-215-6412
  Oregon City
 Willamette Falls Hospital
 Alison K Conlin Ph: 503-215-6412
  Portland
 CCOP - Columbia River Oncology Program
 Alison K Conlin Ph: 503-215-6412
 Providence Cancer Center at Providence Portland Medical Center
 Alison K Conlin Ph: 503-215-6412
 Providence St. Vincent Medical Center
 Alison K Conlin Ph: 503-215-6412
Pennsylvania
  Phoenixville
 Cancer Center at Phoenixville Hospital
 Carl W. Sharer Ph: 610-983-1908
South Carolina
  Anderson
 AnMed Cancer Center
 James Dewitt Bearden Ph: 800-486-5941
 James Dewitt Bearden Ph: 800-486-5941
  Easley
 Cancer Centers of the Carolinas - Easley
 Jeffrey Kent Giguere Ph: 864-241-6251
  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 - Andrews
 Jeffrey Kent Giguere Ph: 864-241-6251
 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
 Joanna K Metzner-Sadurski Ph: 864-725-4771
  Greer
 Cancer Centers of the Carolinas - Greer Radiation Oncology
 Jeffrey Kent Giguere Ph: 864-241-6251
  Lancaster
 Carolina Blood and Cancer Care Associates, PA
 James Dewitt Bearden Ph: 800-486-5941
  Rock Hill
 Carolina Blood and Cancer Care
 James Dewitt Bearden Ph: 800-486-5941
  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
 CCOP - Upstate Carolina
 James Dewitt Bearden Ph: 800-486-5941
 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
 James Dewitt Bearden Ph: 800-486-5941
Texas
  Amarillo
 Texas Tech University Health Sciences Center School of Medicine - Amarillo
 Rakhshanda L Rahman Ph: 806-354-5411
  Dallas
 Baylor University Medical Center - Dallas
 Michael D. Grant Ph: 800-422-9567
  Houston
 Methodist Hospital
 Angel A Rodriguez Ph: 713-790-2700
  Email: burton@bcm.edu
 Univeristy of Texas M.D. Anderson Cancer Center
 Therese B Bevers Ph: 713-792-3245
  Laredo
 Doctor's Hospital of Laredo
 Gary W. Unzeitig Ph: 888-823-5923
  Email: ctsucontact@westat.com
Utah
  Salt Lake City
 Huntsman Cancer Institute at University of Utah
 Leigh A Neumayer Ph: 801-581-4477
  Email: clinical.trials@hci.utah.edu
Washington
  Spokane
 Rockwood Clinic Cancer Treatment Center
 Kirk A. Lund Ph: 509-755-5800
  Vancouver
 Northwest Cancer Specialists at Vancouver Cancer Center
 Alison K Conlin Ph: 503-215-6412
 Southwest Washington Medical Center Cancer Center
 Alison K Conlin Ph: 503-215-6412
West Virginia
  Princeton
 Princeton Community Hospital
 Rowena Gonzales-Chambers Ph: 304-487-7000
Wisconsin
  Janesville
 Mercy Regional Cancer Center
 Robert Delaune Ph: 800-928-1103
  New Richmond
 Cancer Center of Western Wisconsin
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
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

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01097278
ClinicalTrials.gov processed this data on April 06, 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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