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Clinical Trials (PDQ®)

Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent Endometrial Cancer

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase III, Phase IIBiomarker/Laboratory analysis, TreatmentActive18 and overNCI, OtherGOG-0286B
NCI-2013-02284, U10CA180868, U10CA027469, NCT02065687

Trial Description

Summary

This randomized phase II/III trial studies how well paclitaxel, carboplatin, and metformin hydrochloride works and compares it to paclitaxel, carboplatin, and placebo in treating patients with endometrial cancer that is stage III, IV, or has come back. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Metformin hydrochloride may help paclitaxel and carboplatin work better by making cancer cells more sensitive to the drugs. It is not yet known whether paclitaxel and carboplatin is more effective with or without metformin hydrochloride in treating endometrial cancer.

Further Study Information

PRIMARY OBJECTIVES:

I. To determine if the addition of metformin (metformin hydrochloride) to the standard regimen of carboplatin and paclitaxel prolongs progression-free survival (PFS) in women with advanced or recurrent endometrial cancer. (Phase II) II. To determine if the addition of metformin to the standard regimen of carboplatin and paclitaxel prolongs overall survival (OS) in the same population if a phase III study is conducted. Both clinical trials (Phase II and III) will utilize OS as a primary endpoint if a phase III trial is opened.

SECONDARY OBJECTIVES:

I. To estimate the proportion of patients with objective response (response rate [RR]) in the population of patients with measurable disease by treatment.

II. To estimate the duration of response in the population of patients with measurable disease who respond by treatment.

III. To estimate overall survival (OS) and relative hazards of death for each treatment arm if the study stops after the phase II trial is completed. If the study continues with a phase III clinical trial, then PFS will be a secondary endpoint.

IV. To determine the nature, frequency and degree of toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) for each treatment arm.

V. To estimate possible differences in RR, PFS, OS, and toxicity rates for the treatment regimens by the patients' level of obesity.

TERTIARY OBJECTIVES:

I. To explore the association of metabolic factors (i.e. body mass index [BMI], hip-to-waist ratio, diabetes status, hemoglobin A1c [HgbA1C], fasting insulin and glucose levels, homeostatic model assessment [HOMA] scores) with treatment response to metformin/paclitaxel/carboplatin.

II. To correlate expression of the metformin transporter proteins (i.e., organic cation transporters [OCT] 1-3, multidrug and toxin extrusion [MATE] 1/2 and plasma membrane monoamine transporter [PMAT]) and key targets of the metformin/mammalian target of rapamycin (mTOR) signaling pathway with treatment response to metformin/paclitaxel/carboplatin.

III. To estimate differences in physical functioning, physical activity, and fatigue between treatment arms.

IV. To explore the association between metabolic factors (i.e., BMI, hip-to-waist ratio, diabetes status, HgbA1C, fasting insulin and glucose levels, HOMA scores) and physical functioning, physical activity, and fatigue.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours on day 1, carboplatin IV over 30 minutes on day 1, and metformin hydrochloride orally (PO) twice daily (BID) on days 1-21 (once daily [QD] in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive paclitaxel IV and carboplatin IV as in Arm I. Patients also receive placebo PO BID on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Eligibility Criteria

Inclusion Criteria:

  • Patients must have measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial carcinoma
  • Histologic confirmation of the original primary tumor is required; patients with the following histologic epithelial cell types are eligible:
  • Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.)
  • Measurable disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1); measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI
  • Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl
  • Platelets greater than or equal to 100,000/mcl
  • Creatinine less than 1.4 mg/dl
  • Bilirubin less than or equal to 1.5 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 x ULN
  • Alkaline phosphatase less than or equal to 2.5 x ULN
  • Patients must NOT have received prior chemotherapy or targeted therapy, including chemotherapy used for radiation sensitization for treatment of endometrial carcinoma
  • Patients may have received prior radiation therapy for treatment of endometrial carcinoma; prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para-aortic radiation therapy, and/or intravaginal brachytherapy; all radiation therapy must be completed at least 4 weeks prior to the first date of study therapy
  • Patients may have received prior hormonal therapy for treatment of endometrial carcinoma; all hormonal therapy must be discontinued at least one week prior to the first date of study therapy
  • Patients must be able to swallow and retain orally-administered medication
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information; individuals with impaired decision-making capacity are not eligible to participate on the study

Exclusion Criteria:

  • Patients must NOT be taking metformin or have been on metformin in the past 6 months
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer are excluded if there is any evidence of other malignancy being present within the last three years
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients who are pregnant or nursing; if patients are of reproductive age and have not undergone hysterectomy, they must use an effective contraceptive method for the duration of this study
  • Any condition associated with increased risk of metformin-associated lactic acidosis. (e.g. congestive heart failure defined as New York Heart Association [NYHA] class III or IV functional status, history of acidosis of any type; habitual intake of 3 or more alcoholic beverages per day)

Trial Contact Information

Trial Lead Organizations/Sponsors

Gynecologic Oncology Group

National Cancer Institute

NRG Oncology

Victoria Bae-JumpPrincipal Investigator

Trial Sites

U.S.A.
Alabama
  Birmingham
 UAB Comprehensive Cancer Center
 Warner Huh Ph: 205-934-0309
  Huntsville
 Tennessee Valley Gynecologic Oncology
 David B Engle Ph: 256-533-6233
Arizona
  Phoenix
 St. Joseph's Hospital and Medical Center
 John H Farley Ph: 877-602-4111
Arkansas
  Little Rock
 Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
 Kristin K Zorn Ph: 501-686-8274
California
  La Jolla
 Rebecca and John Moores UCSD Cancer Center
 Michael T. McHale Ph: 858-822-5354
  Email: cancercto@ucsd.edu
  Los Angeles
 Jonsson Comprehensive Cancer Center at UCLA
 Robin Farias-Eisner Ph: 888-798-0719
 Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
 Bobbie J Rimel Ph: 310-423-3348
  Email: paula.anastasia@cshs.org
  Mountain View
 Palo Alto Medical Foundation
 Albert L Pisani Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  Oakland
 Kaiser Permanente-Oakland
 Louis Fehrenbacher Ph: 626-564-3455
  Orange
 St. Joseph Hospital Regional Cancer Center - Orange
 Leslie M Randall Ph: 877-827-8839
  Email: ucstudy@uci.edu
  Roseville
 Kaiser Permanente Medical Center - Roseville
 Louis Fehrenbacher Ph: 626-564-3455
  Sacramento
 Kaiser Permanente Medical Center - Sacramento
 Louis Fehrenbacher Ph: 626-564-3455
  San Francisco
 Kaiser Permanente Medical Center - San Francisco Geary Campus
 Louis Fehrenbacher Ph: 626-564-3455
  San Jose
 Kaiser Permanente Medical Center - Santa Teresa
 Louis Fehrenbacher Ph: 626-564-3455
  San Leandro
 Kaiser Permanente Medical Center - Hayward
 Louis Fehrenbacher Ph: 626-564-3455
  Santa Clara
 Kaiser Permanente Medical Center - Santa Clara Homestead Campus
 Louis Fehrenbacher Ph: 626-564-3455
  South San Francisco
 Kaiser Permanente Medical Center - South San Francisco
 Louis Fehrenbacher Ph: 626-564-3455
  Stanford
 Stanford Cancer Center
 Oliver Dorigo Ph: 650-498-7061
  Email: ccto-office@stanford.edu
  Sylmar
 Olive View - UCLA Medical Center Foundation
 Christine Holschneider Ph: 888-798-0719
  Vallejo
 Kaiser Permanente Medical Center - Vallejo
 Louis Fehrenbacher Ph: 626-564-3455
  Walnut Creek
 Kaiser Permanente Medical Center - Walnut Creek
 Louis Fehrenbacher Ph: 626-564-3455
Connecticut
  Hartford
 Helen and Harry Gray Cancer Center at Hartford Hospital
 James S. Hoffman Ph: 860-224-5660
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Philip J. Stella Ph: 734-712-4673
  New Britain
 George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
 James S. Hoffman Ph: 860-224-5660
  New Haven
 Yale Cancer Center
 Elena S Ratner Ph: 203-785-5702
Florida
  Gainesville
 UF Health Cancer Center
 Merry J Markham Ph: 352-273-8675
  Email: trials@cancer.ufl.edu
  Orlando
 Florida Hospital Cancer Institute at Florida Hospital Orlando
 James E Kendrick Ph: 407-303-5623
  Sarasota
 Sarasota Memorial Hospital
 James V. Fiorica Ph: 941-917-2225
Georgia
  Atlanta
 Northside Hospital Cancer Center
 Guilherme C. Cantuaria Ph: 404-303-3355
  Email: clinicaltrials@northside.com
  Decatur
 Charles B. Eberhart Cancer Center at DeKalb Medical Center
 Cyril O Spann Ph: 404-501-3279
  Gainesville
 Northeast Georgia Medical Center
 Andrew E Green 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
 William Edward Richards Ph: 800-622-6877
Hawaii
  Aiea
 Kapiolani Medical Center at Pali Momi
 Michael E. Carney Ph: 808-983-6090
 Michael E. Carney Ph: 808-983-6090
  Ewa Beach
 Leeward Radiation Oncology
 Michael E. Carney Ph: 808-983-6090
  Honolulu
 Cancer Research Center of Hawaii
 Michael E. Carney Ph: 808-983-6090
 Hawaii Medical Center - East
 Michael E. Carney Ph: 808-983-6090
 Kapiolani Medical Center for Women and Children
 Michael E. Carney Ph: 808-983-6090
 Kuakini Medical Center
 Michael E. Carney Ph: 808-983-6090
 OnCare Hawaii, Incorporated - Kuakini
 Michael E. Carney Ph: 808-983-6090
 Michael E. Carney Ph: 808-983-6090
 OnCare Hawaii, Incorporated - Lusitana
 Michael E. Carney Ph: 808-983-6090
 Queen's Cancer Institute at Queen's Medical Center
 Michael E. Carney Ph: 808-983-6090
 Straub Clinic and Hospital, Incorporated
 Michael E. Carney Ph: 808-983-6090
  Lihue
 Kauai Medical Clinic
 Michael E. Carney Ph: 808-983-6090
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Philip J. Stella Ph: 734-712-4673
Illinois
  Chicago
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 Emily Berry Ph: 312-695-1301
  Email: cancer@northwestern.edu
 University of Chicago Cancer Research Center
 Meaghan E Tenney Ph: 773-834-7424
  Decatur
 Cancer Care Center of Decatur
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
 Decatur Memorial Hospital Cancer Care Institute
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Hinsdale
 Gynecologic Oncology
 Sudarshan K. Sharma Ph: 630-856-6757
  New Lennox
 Silver Cross Hospital
 Meaghan E Tenney Ph: 773-834-7424
Indiana
  Elkhart
 Michiana Hematology-Oncology, PC - Elkhart
 Michael W. Method Ph: 574-237-1328
  Indianapolis
 Indiana University Melvin and Bren Simon Cancer Center
 Frederick B Stehman Ph: 317-274-2552
 St. Vincent Oncology Center
 Gregory P. Sutton Ph: 317-338-2194
  Mishawaka
 Michiana Hematology-Oncology, PC - Mishawaka
 Michael W. Method Ph: 574-237-1328
 Saint Joseph's Medical Center
 Michael W. Method Ph: 574-237-1328
  South Bend
 Michiana Hematology-Oncology, PC - South Bend
 Michael W. Method Ph: 574-237-1328
  Westville
 Michiana Hematology Oncology-PC Westville
 Michael W. Method Ph: 574-237-1328
Iowa
  Ames
 McFarland Clinic, PC
 Joseph James Merchant Ph: 515-239-2621
 William R. Bliss Cancer Center at Mary Greeley Medical Center
 Joseph James Merchant Ph: 515-239-2621
  Boone
 McFarland Clinic PC-Boone
 Joseph James Merchant Ph: 515-239-2621
  Fort Dodge
 Trinity Regional Medical Center
 Joseph James Merchant Ph: 515-239-2621
  Iowa City
 Holden Comprehensive Cancer Center at University of Iowa
 David P Bender Ph: 800-237-1225
  Jefferson
 McFarland Clinic PC-Jefferson
 Joseph James Merchant Ph: 515-239-2621
  Marshalltown
 McFarland Clinic PC-Marshalltown
 Joseph James Merchant Ph: 515-239-2621
Kentucky
  Edgewood
 St. Elizabeth Medical Center
 Kevin M Schuler Ph: 859-301-5473
  Email: darla.hehman@stelizabeth.com
  Lexington
 University of Kentucky Chandler Medical Center
 Frederick Ueland Ph: 859-257-3379
Louisiana
  Baton Rouge
 Woman's Hospital
 Giles Fort Ph: 225-215-1353
  Email: clinicalreserach@marybird.com
  New Orleans
 Ochsner Cancer Institute at Ochsner Clinic Foundation
 Richard C. Kline Ph: 888-562-4763
Maine
  Scarborough
 Maine Medical Center- Scarborough Campus
 Christopher J Darus Ph: 207-885-7565
Maryland
  Baltimore
 Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
 Mark A Miller Ph: 877-441-7957
 Greater Baltimore Medical Center Cancer Center
 Paul Celano Ph: 443-849-3706
 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 Deborah K. Armstrong Ph: 410-955-8804
  Email: jhcccro@jhmi.edu
Massachusetts
  Boston
 Tufts Medical Center Cancer Center
 Young B Kim Ph: 617-636-5000
  Email: ContactUsCancerCenter@TuftsMedicalCenter.org
  Lowell
 Lowell General Hospital
 Blair Ardman Ph: 978-788-7084
  Email: ghincks@lowellgeneral.org
Michigan
  Ann Arbor
 Saint Joseph Mercy Cancer Center
 Philip J. Stella Ph: 734-712-4673
 University of Michigan Comprehensive Cancer Center
 Carolyn M. Johnston Ph: 734-712-3456
  Battle Creek
 Battle Creek Health System Cancer Care Center
 Gilbert D Padula Ph: 616-685-5225
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Philip J. Stella Ph: 734-712-4673
  Detroit
 Wayne State University
 Robert T. Morris Ph: 313-576-9363
  Escanaba
 Green Bay Oncology, Limited - Escanaba
 Jonathan E Tammela Ph: 920-433-8889
  Farmington Hills
 Weisberg Cancer Treatment Center
 Robert T. Morris Ph: 313-576-9363
  Flint
 Genesys Hurley Cancer Institute
 Philip J. Stella Ph: 734-712-4673
 Hurley Medical Center
 Philip J. Stella Ph: 734-712-4673
  Grand Rapids
 Butterworth Hospital at Spectrum Health
 Gilbert D Padula Ph: 616-685-5225
 Helen DeVos Children's Hospital at Spectrum Health
 Gilbert D Padula Ph: 616-685-5225
 Lacks Cancer Center at Saint Mary's Health Care
 Gilbert D Padula Ph: 616-685-5225
  Iron Mountain
 Green Bay Oncology - Iron Mountain
 Jonathan E Tammela Ph: 920-433-8889
  Jackson
 Gayle M. Jacob Cancer Center at Allegiance Health
 Philip J. Stella Ph: 734-712-4673
  Kalamazoo
 West Michigan Cancer Center
 Sunil Nagpal Ph: 269-373-7458
  Lansing
 Sparrow Regional Cancer Center
 Philip J. Stella Ph: 734-712-4673
  Livonia
 St. Mary Mercy Hospital
 Philip J. Stella Ph: 734-712-4673
  Muskegon
 Mercy General Health Partners
 Gilbert D Padula Ph: 616-685-5225
  Pontiac
 St. Joseph Mercy Oakland
 Philip J. Stella Ph: 734-712-4673
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Philip J. Stella Ph: 734-712-4673
  Reed City
 Spectrum Health Reed City Hospital
 Gilbert D Padula Ph: 616-685-5225
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Philip J. Stella Ph: 734-712-4673
  Traverse City
 Munson Medical Center
 Gilbert D Padula Ph: 616-685-5225
  Warren
 St. John Macomb Hospital
 Philip J. Stella Ph: 734-712-4673
Minnesota
  Coon Rapids
 Mercy and Unity Cancer Center at Mercy Hospital
 Matthew P Boente Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Edina
 Fairview Southdale Hospital
 Matthew P Boente Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Minneapolis
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Matthew P Boente Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Saint Louis Park
 Park Nicollet Cancer Center
 Matthew P Boente Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Saint Paul
 United Hospital
 Matthew P Boente Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Woodbury
 Minnesota Oncology - Woodbury
 Matthew P Boente Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
Mississippi
  Jackson
 St. Dominic Cancer Center
 Donald P Seago Ph: 601-200-3300
 University of Mississippi Cancer Clinic
 James Tate Thigpen Ph: 601-815-6700
Missouri
  Cape Girardeau
 Saint Francis Medical Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Rolla
 Phelps County Regional Medical Center
 Jay W Carlson Ph: 800-821-7532
  Saint Louis
 David C. Pratt Cancer Center at St. John's Mercy
 Jay W Carlson Ph: 800-821-7532
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 David Gardner Mutch Ph: 800-600-3606
  Email: info@ccadmin.wustl.edu
  Springfield
 Hulston Cancer Center at Cox Medical Center South
 Jay W Carlson Ph: 800-821-7532
 St. John's Regional Health Center
 Jay W Carlson Ph: 800-821-7532
Nebraska
  Omaha
 Methodist Estabrook Cancer Center
 Peter C. Morris Ph: 402-354-7939
  Email: kathryn.bartz@nmhs.org
Nevada
  Las Vegas
 Women's Cancer Center - La Canada
 Nick M. Spirtos Ph: 702-851-4672
  Reno
 Renown Institute for Cancer at Renown Regional Medical Center
 Peter C Lim Ph: 866-513-8227
 Peter C Lim Ph: 866-513-8227
New Hampshire
  Lebanon
 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
 Leslie R. DeMars Ph: 800-639-6918
  Email: cancer.research.nurse@dartmouth.edu
New Jersey
  Camden
 Cancer Institute of New Jersey at Cooper University Hospital - Camden
 David P. Warshal Ph: 856-325-6757
  Mount Holly
 Virtua Fox Chase Health Cancer Program at Virtua Memorial Hospital Burlington County
 Randolph B Deger Ph: 888-847-8823
  Voorhees
 Cancer Institute of New Jersey at Cooper - Voorhees
 David P. Warshal Ph: 856-325-6757
 Fox Chase Virtua Health Cancer Program at Virtua West Jersey
 Randolph B Deger Ph: 888-847-8823
New Mexico
  Albuquerque
 Southwest Gynecologic Oncology Associates, Incorporated
 Teresa L Rutledge Ph: 505-272-6972
 University of New Mexico Cancer Center
 Teresa L Rutledge Ph: 505-272-6972
New York
  Albany
 Women's Cancer Care Associates
 Daniel Casey Kredentser Ph: 518-458-1390
  New York
 Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
 Thomas J. Herzog Ph: 513-558-4553
  Email: uchealthnews@uc.edu
 Memorial Sloan-Kettering Cancer Center
 Carol Aghajanian Ph: 212-639-7202
 Mount Sinai Medical Center
 Monica P Hayes Ph: 212-824-7320
  Email: jenny.figueroa@mssm.edu
 New York University Medical Center
 Stephanie V. Blank Ph: 212-263-4434
  Email: prmc.coordinator@nyumc.org
North Carolina
  Chapel Hill
 Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
 Linda Van Le Ph: 877-668-0683
  Email: cancerclinicaltrials@med.unc.edu
  Charlotte
 Blumenthal Cancer Center at Carolinas Medical Center
 Robert Victor Higgins Ph: 704-355-2884
 Presbyterian Cancer Center at Presbyterian Hospital
 John M McDonald Ph: 704-384-5369
  Concord
 Batte Cancer Center at Northeast Medical Center
 Robert Victor Higgins Ph: 704-355-2884
  Durham
 Duke Cancer Institute
 Angeles Alvarez Secord Ph: 888-275-3853
  Hendersonville
 Park Ridge Hospital Breast Health Center
 David Griffin Ph: 864-512-1000
  Pinehurst
 FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
 Michael J Sundborg Ph: 910-715-2200
  Raleigh
 Duke Health Raleigh Hospital
 Angeles Alvarez Secord Ph: 888-275-3853
  Winston-Salem
 Wake Forest University Comprehensive Cancer Center
 Samuel S. Lentz Ph: 336-713-6771
Ohio
  Akron
 Summa Center for Cancer Care at Akron City Hospital
 Vivian von Gruenigen Ph: 330-375-6101
  Cincinnati
 Bethesda North Hospital
 Kevin M Schuler Ph: 859-301-5473
  Email: darla.hehman@stelizabeth.com
 Good Samaritan Hospital Cancer Treatment Center
 Kevin M Schuler Ph: 859-301-5473
  Email: darla.hehman@stelizabeth.com
 University of Cincinnati
 Eric L Eisenhauer Ph: 513-558-4553
  Email: uchealthnews@uc.edu
  Cleveland
 Case Comprehensive Cancer Center
 Steven E. Waggoner Ph: 800-641-2422
 Cleveland Clinic Cancer Center at Fairview Hospital
 Peter Graham Rose Ph: 866-223-8100
 Cleveland Clinic Taussig Cancer Center
 Peter Graham Rose Ph: 866-223-8100
  Columbus
 Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
 David M O'Malley Ph: 866-627-7616
  Email: osu@emergingmed.com
 Riverside Methodist Hospital Cancer Care
 J. Philip Kuebler Ph: 614-566-3275
 Zangmeister Center
 J. Philip Kuebler Ph: 614-566-3275
  Dayton
 Grandview Hospital
 Eric L Eisenhauer Ph: 513-558-4553
  Email: uchealthnews@uc.edu
  Mayfield Heights
 Hillcrest Cancer Center at Hillcrest Hospital
 Peter Graham Rose Ph: 866-223-8100
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Robert S. Mannel Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
  Tulsa
 Cancer Care Associates-Yale
 Robert S. Mannel Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Pennsylvania
  Abington
 Rosenfeld Cancer Center at Abington Memorial Hospital
 Parviz Hanjani Ph: 215-481-2402
  Gettysburg
 Adams Cancer Center
 Mark A Miller Ph: 877-441-7957
  Hanover
 Cherry Tree Cancer Center
 Mark A Miller Ph: 877-441-7957
  Philadelphia
 Abramson Cancer Center of the University of Pennsylvania
 Robert A. Burger Ph: 215-746-7406
 Fox Chase Cancer Center - Philadelphia
 Angela Jain Ph: 215-728-4790
 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
 Christine H Kim Ph: 215-955-6084
 Temple Cancer Center at Temple University Hospital
 Enrique Hernandez Ph: 215-728-2983
  West Reading
 McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
 Bernice L Robinson-Bennett Ph: 610-988-9323
  York
 WellSpan Health
 Mark A Miller Ph: 877-441-7957
Rhode Island
  Providence
 Women and Infants Hospital of Rhode Island
 Paul A. DiSilvestro Ph: 401-274-1122
South Carolina
  Anderson
 AnMed Cancer Center
 David Griffin Ph: 864-512-1000
  Charleston
 Hollings Cancer Center at Medical University of South Carolina
 Whitney S Graybill Ph: 843-792-9321
  Greenville
 Bon Secours St. Francis Health System
 David Griffin Ph: 864-512-1000
  Greer
 Gibbs Cancer Center-Pelham
 David Griffin Ph: 864-512-1000
  Lancaster
 Carolina Blood and Cancer Care Associates, PA
 David Griffin Ph: 864-512-1000
  Rock Hill
 Carolina Blood and Cancer Care
 David Griffin Ph: 864-512-1000
  Spartanburg
 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
 David Griffin Ph: 864-512-1000
South Dakota
  Rapid City
 Black Hills Obstetrics & Gynecology LLP
 Helen L. Frederickson Ph: 605-343-9224
 Rapid City Regional Hospital
 Helen L. Frederickson Ph: 605-343-9224
  Sioux Falls
 Avera Cancer Institute
 Luis A Rojas-Espaillat Ph: 800-657-4377
  Email: Jan.Healy@avera.org
Texas
  Austin
 University Medical Center Brackenridge
 John L Dalrymple Ph: 512-324-7991
  Dallas
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 David Scott Miller Ph: 214-648-7097
  Houston
 Memorial Hermann - Texas Medical Center
 Anthony Lucci Ph: 866-574-5124
  Email: Sylvester@emergingmed.com
Utah
  Salt Lake City
 Huntsman Cancer Institute at University of Utah
 Theresa L Werner Ph: 801-581-4477
  Email: clinical.trials@hci.utah.edu
Vermont
  Burlington
 Fletcher Allen Health Care - Medical Center Campus
 Cheung Wong Ph: 802-656-8990
Virginia
  Charlottesville
 University of Virginia Cancer Center
 Susan C Modesitt Ph: 434-243-6143
  Richmond
 Virginia Commonwealth University Massey Cancer Center
 Jori S Carter Ph: 804-628-1939
Wisconsin
  Green Bay
 Green Bay Oncology, Limited at St. Mary's Hospital
 Jonathan E Tammela Ph: 920-433-8889
 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
 Jonathan E Tammela Ph: 920-433-8889
 St. Mary's Hospital Medical Center - Green Bay
 Jonathan E Tammela Ph: 920-433-8889
 St. Vincent Hospital Regional Cancer Center
 Jonathan E Tammela Ph: 920-433-8889
  Manitowoc
 Holy Family Memorial Medical Center Cancer Care Center
 Jonathan E Tammela Ph: 920-433-8889
  Mukwonago
 D.N. Greenwald Center
 Janet Drake Ph: 262-928-7632
  Oconomowoc
 Regional Cancer Center at Oconomowoc Memorial Hospital
 Janet Drake Ph: 262-928-7632
  Oconto Falls
 Green Bay Oncology, Limited - Oconto Falls
 Jonathan E Tammela Ph: 920-433-8889
  Sturgeon Bay
 Green Bay Oncology, Limited - Sturgeon Bay
 Jonathan E Tammela Ph: 920-433-8889
  Waukesha
 Waukesha Memorial Hospital Regional Cancer Center
 Janet Drake Ph: 262-928-7632

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT02065687
ClinicalTrials.gov processed this data on November 12, 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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