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

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Basic Trial Information

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

Tucson

Arizona Cancer Center at University Medical Center North

Setsuko K Chambers
Ph: 520-626-9008

Arizona Cancer Center at University of Arizona Health Sciences Center

Setsuko K Chambers
Ph: 520-626-9008

Arizona Oncology Associates-Wilmot

Michael A. Bookman
Ph: 520-626-9008

Arkansas
Little Rock

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Kristin K Zorn
Ph: 501-686-8274

California
Concord

Cancer Care Center at John Muir Health - Concord Campus

Babak Edraki
Ph: 925-674-2580

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

Kaiser Permanente Medical Center - Los Angeles

Scott E. Lentz
Ph: 626-564-3455

Mountain View

Palo Alto Medical Foundation

John K Chan
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Oakland

Kaiser Permanente-Oakland

Louis Fehrenbacher
Ph: 626-564-3455

Orange

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

Krishnansu S Tewari
Ph: 714-456-6191
Email: awallick@uci.edu

St. Joseph Hospital Regional Cancer Center - Orange

Leslie M Randall
Ph: 714-734-6220

Palo Alto

Palo Alto Medical Foundation - Palo Alto

John K Chan
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Stanford Cancer Center

Oliver Dorigo
Ph: 650-498-7061
Email: ccto-office@stanford.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

University of California Davis Cancer Center

Edwin A Alvarez
Ph: 916-734-3089

San Francisco

California Pacific Medical Center - California Campus

John K Chan
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Kaiser Permanente Medical Center - San Francisco Geary Campus

Louis Fehrenbacher
Ph: 626-564-3455

San Francisco General Hospital Medical Center

Rebecca A Brooks
Ph: 877-827-3222

UCSF Helen Diller Family Comprehensive Cancer Center

Rebecca A Brooks
Ph: 877-827-3222

Rebecca A Brooks
Ph: 877-827-3222

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

Santa Cruz

Palo Alto Medical Foundation-Santa Cruz

John K Chan
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

South San Francisco

Kaiser Permanente Medical Center - South San Francisco

Louis Fehrenbacher
Ph: 626-564-3455

Sunnyvale

Palo Atlo Medical Foundation-Sunnyvale

John K Chan
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Vallejo

Kaiser Permanente Medical Center - Vallejo

Louis Fehrenbacher
Ph: 626-564-3455

Walnut Creek

John Muir/Mt. Diablo Comprehensive Cancer Center

Babak Edraki
Ph: 925-674-2580

Kaiser Permanente Medical Center - Walnut Creek

Louis Fehrenbacher
Ph: 626-564-3455

Colorado
Aurora

University of Colorado Cancer Center at UC Health Sciences Center

Susan Davidson
Ph: 720-848-0650

Fort Collins

Poudre Valley Hospital

Susan Davidson
Ph: 720-848-0650

Connecticut
Hartford

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Philip J. Stella
Ph: 734-712-4673

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

Emory University Hospital Midtown

Namita Khanna
Ph: 404-778-1868

Northside Hospital Cancer Center

Guilherme C. Cantuaria
Ph: 404-303-3355
Email: clinicaltrials@northside.com

Winship Cancer Institute of Emory University

Namita Khanna
Ph: 404-778-1868

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
Aurora

Rush-Copley Cancer Care Center

Maria T Grosse-Perdekamp
Ph: 800-446-5532

Bloomington

Illinois CancerCare - Bloomington

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

Canton

Illinois CancerCare - Canton

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

Carthage

Illinois CancerCare - Carthage

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

Chicago

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Emily Berry
Ph: 312-695-1301
Email: cancer@northwestern.edu

Rush Cancer Institute at Rush University Medical Center

Alfred S Guirguis
Ph: 312-942-5498
Email: clinical_trials@rush.edu

University of Chicago Cancer Research Center

Meaghan E Tenney
Ph: 773-834-7424

Danville

Carle on Vermilion

Maria T Grosse-Perdekamp
Ph: 800-446-5532

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

Effingham

Carle Physician Group-Effingham

Maria T Grosse-Perdekamp
Ph: 800-446-5532

Eureka

Illinois CancerCare - Eureka

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

Evanston

CCOP - Evanston

Jean A. Hurteau
Ph: 847-570-2109

Galesburg

Galesburg Clinic, PC

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

Glenview

Glenbrook Hospital

Jean A. Hurteau
Ph: 847-570-2109

Highland Park

Highland Park Hospital

Jean A. Hurteau
Ph: 847-570-2109

Hinsdale

Gynecologic Oncology

Sudarshan K. Sharma
Ph: 630-856-6757

Kewanee

Illinois CancerCare - Kewanee Clinic

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

Macomb

Illinois CancerCare - Macomb

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

Mattoon

Carle Physician Group-Mattoon/Charleston

Maria T Grosse-Perdekamp
Ph: 800-446-5532

New Lennox

Silver Cross Hospital

Meaghan E Tenney
Ph: 773-834-7424

Ottawa

Illinois CancerCare - Ottawa

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

Pekin

Illinois CancerCare - Pekin

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

Peoria

Illinois CancerCare - Peoria

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

Peru

Illinois CancerCare - Princeton

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

Princeton

Illinois CancerCare - Princeton

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

Skokie

Rush North Shore Medical Center

Jean A. Hurteau
Ph: 847-570-2109

Springfield

Central Illinois Hematology Oncology Center

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

Regional Cancer Center at Memorial Medical Center

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

Simmons Cooper Cancer Institute

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

Springfield Clinic - Main Campus

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

Swansea

Cancer Care Specialists of Illinois-Swansea

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

Urbana

Carle Cancer Center at Carle Foundation Hospital

Maria T Grosse-Perdekamp
Ph: 800-446-5532

Maria T Grosse-Perdekamp
Ph: 800-446-5532

Warrenville

Central Dupage Cancer Center

LaToya J Perry
Ph: 630-208-4563
Email: kevin.tomczyk@delnor.com

Yorkville

Rush-Copley Healthcare Center

Maria T Grosse-Perdekamp
Ph: 800-446-5532

Indiana
Crown Point

Michiana Hematology Oncology PC-Crown Point

Michael W. Method
Ph: 574-237-1328

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

Michael J Callahan
Ph: 317-338-2194
Email: research@stvincent.org

Michigan City

Saint Anthony Memorial Health Centers

Maria T Grosse-Perdekamp
Ph: 800-446-5532

Woodland Cancer Care Center

Maria T Grosse-Perdekamp
Ph: 800-446-5532

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

Mason City

Mercy Cancer Center at Mercy Medical Center - North Iowa

Arvind Y Vemula
Ph: 800-433-3883

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: 225-231-5296
Email: Ericka.Seidemann@womans.org

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

Bethesda

National Naval Medical Center

Michael P Stany
Ph: 301-319-2100

Massachusetts
Boston

Dana-Farber/Brigham and Women's Cancer Center

Neil S Horowitz
Ph: 617-724-5200

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

Neil S Horowitz
Ph: 617-724-5200

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

Worcester

Levine Cancer Center at UMass Medical Center - Memorial Campus

Susan L. Zweizig
Ph: 508-856-3216
Email: cancer.research@umassmed.edu

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
Email: connie.szczepanek@grcop.org

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
Email: connie.szczepanek@grcop.org

Helen DeVos Children's Hospital at Spectrum Health

Gilbert D Padula
Ph: 616-685-5225
Email: connie.szczepanek@grcop.org

Lacks Cancer Center at Saint Mary's Health Care

Gilbert D Padula
Ph: 616-685-5225
Email: connie.szczepanek@grcop.org

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
Email: connie.szczepanek@grcop.org

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
Email: connie.szczepanek@grcop.org

Royal Oak

William Beaumont Hospital - Royal Oak Campus

Jayson B Field
Ph: 248-551-7695

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
Email: connie.szczepanek@grcop.org

Troy

William Beaumont Hospital - Troy Campus

Jayson B Field
Ph: 248-551-7695

Warren

St. John Macomb Hospital

Philip J. Stella
Ph: 734-712-4673

Minnesota
Bemidji

MeritCare Bemidji

Maria C. Bell
Ph: 218-333-5000

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

Rochester

Mayo Clinic Cancer Center

Jamie N Bakkum-Gamez
Ph: 507-538-7623

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

Mercy Clinic Cancer and Hematology - Rolla

Jay W Carlson
Ph: 800-821-7532

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
Basking Ridge

Memorial Sloan-Kettering Cancer Center - Basking Ridge

Carol Aghajanian
Ph: 212-639-7202

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
Brooklyn

New York Methodist Hospital

Katherine Economos
Ph: 718-780-5240

Commack

Memorial Sloan-Kettering Cancer Center

Carol Aghajanian
Ph: 212-639-7202

Mineola

Winthrop University Hospital

Jeannine A Villella
Ph: 866-946-8476

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

Rockville Centre

Memorial Sloan-Kettering Cancer Center - Rockville Centre

Carol Aghajanian
Ph: 212-639-7202

Sleepy Hollow

Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center

Carol Aghajanian
Ph: 212-639-7202

Stony Brook

Stony Brook University Cancer Center

Jeannine A Villella
Ph: 866-946-8476

Valhalla

Westchester Medical Center

Sean S Tedjarati
Ph: 800-862-2215

West Harrison

Memorial Sloan-Kettering Cancer Center West Harrison

Carol Aghajanian
Ph: 212-639-7202

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

North Dakota
Bismarck

Medcenter One Hospital Cancer Care Center

Maria C. Bell
Ph: 218-333-5000

Fargo

Roger Maris Cancer Center at MeritCare Hospital

Maria C. Bell
Ph: 218-333-5000

Maria C. Bell
Ph: 218-333-5000

Sanford Clinic North-Fargo

Maria C. Bell
Ph: 218-333-5000

Ohio
Akron

Summa Center for Cancer Care at Akron City Hospital

Vivian von Gruenigen
Ph: 330-375-6101

Cincinnati

Bethesda North Hospital

Mehmet S. Copur
Ph: 800-998-2119

Good Samaritan Hospital Cancer Treatment Center

Mehmet S. Copur
Ph: 800-998-2119

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: 800-293-5066
Email: Jamesline@osumc.edu

Riverside Methodist Hospital Cancer Care

J. Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

Zangmeister Center

J. Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

Dayton

David L. Rike Cancer Center at Miami Valley Hospital

Howard M. Gross
Ph: 937-775-1350

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

Wright-Patterson Afb

United States Air Force Medical Center - Wright-Patterson

Yovanni Casablanca
Ph: 937-257-1398

Oklahoma
Oklahoma City

Stephenson Cancer Center at the University of Oklahoma

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

Danville

Geisinger Cancer Institute at Geisinger Health

Radhika P Gogoi
Ph: 570-271-5251

Gettysburg

Adams Cancer Center

Mark A Miller
Ph: 877-441-7957

Greensburg

UPMC Cancer Center - Arnold Palmer Pavilion

Alexander B Olawaiye
Ph: 412-647-2811

Hanover

Cherry Tree Cancer Center

Mark A Miller
Ph: 877-441-7957

Hazleton

Geisinger Hazleton Cancer Center

Radhika P Gogoi
Ph: 570-271-5251

Lewisburg

Geisinger Medical Oncology at Evangelical Community Hospital

Radhika P Gogoi
Ph: 570-271-5251

Lewistown

Lewistown Hospital

Radhika P Gogoi
Ph: 570-271-5251

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

Pittsburgh

UPMC Cancer Center at Magee-Womens Hospital

Alexander B Olawaiye
Ph: 412-647-2811

UPMC Cancer Center at UPMC Passavant

Alexander B Olawaiye
Ph: 412-647-2811

UPMC Cancer Centers

Alexander B Olawaiye
Ph: 412-647-2811

Pottsville

Geisinger Medical Oncology-Pottsville

Radhika P Gogoi
Ph: 570-271-5251

Seneca

UPMC Cancer Center at UPMC Northwest

Alexander B Olawaiye
Ph: 412-647-2811

State College

Geisinger Medical Group - Scenery Park

Radhika P Gogoi
Ph: 570-271-5251

Uniontown

UPMC Cancer Center - Uniontown

Alexander B Olawaiye
Ph: 412-647-2811

West Chester

Cancer Center of Chester County

William E. Luginbuhl
Ph: 610-431-5297

West Reading

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

Bernice L Robinson-Bennett
Ph: 610-988-9323

Wilkes-Barre

Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

Radhika P Gogoi
Ph: 570-271-5251

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

Sanford Cancer Center at Sanford USD Medical Center

Maria C. Bell
Ph: 218-333-5000

Maria C. Bell
Ph: 218-333-5000

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

Texas Oncology, PA at Charles A. Sammons Cancer Center

Michael A. Bookman
Ph: 520-626-9008

Fort Worth

Texas Oncology, PA - Fort Worth

Michael A. Bookman
Ph: 520-626-9008

Houston

Memorial Hermann - Texas Medical Center

Anthony Lucci
Ph: 866-574-5124
Email: Sylvester@emergingmed.com

Methodist Hospital

Aparna A Kamat
Ph: 713-790-2700

The Woodlands

Texas Oncology-The Woodlands

Michael A. Bookman
Ph: 520-626-9008

Utah
American Fork

American Fork Hospital

Xylina T Gregg
Ph: 801-933-6070
Email: research@utahcancer.com

Cedar City

Sandra L. Maxwell Cancer Center

Xylina T Gregg
Ph: 801-933-6070
Email: research@utahcancer.com

Logan

Logan Regional Hospital

Xylina T Gregg
Ph: 801-933-6070
Email: research@utahcancer.com

Murray

Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

Xylina T Gregg
Ph: 801-933-6070
Email: research@utahcancer.com

Ogden

Val and Ann Browning Cancer Center at McKay-Dee Hospital Center

Xylina T Gregg
Ph: 801-933-6070
Email: research@utahcancer.com

Provo

Utah Valley Regional Medical Center - Provo

Xylina T Gregg
Ph: 801-933-6070
Email: research@utahcancer.com

Saint George

Dixie Regional Medical Center - East Campus

Xylina T Gregg
Ph: 801-933-6070
Email: research@utahcancer.com

Salt Lake City

Huntsman Cancer Institute at University of Utah

Theresa L Werner
Ph: 801-581-4477
Email: clinical.trials@hci.utah.edu

LDS Hospital

Xylina T Gregg
Ph: 801-933-6070
Email: research@utahcancer.com

Utah Cancer Specialists at UCS Cancer Center

Xylina T Gregg
Ph: 801-933-6070
Email: research@utahcancer.com

Vermont
Bennington

Southwestern Vermont Regional Cancer Center

Leslie R. DeMars
Ph: 800-639-6918
Email: cancer.research.nurse@dartmouth.edu

Burlington

University of Vermont Medical Center

Cheung Wong
Ph: 802-656-4101

Virginia
Charlottesville

University of Virginia Cancer Center

Susan C Modesitt
Ph: 434-243-6143

Richmond

Henrico Doctors' Hospital Cancer Center - Forest Campus

Jori S Carter
Ph: 804-628-1939

Virginia Commonwealth University Massey Cancer Center

Jori S Carter
Ph: 804-628-1939

Virginia Gynecologic Oncology

Jori S Carter
Ph: 804-628-1939

Washington
Gig Harbor

MultiCare Gig Harbor Medical Park

John A Keech
Ph: 907-458-5380

Seattle

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Heidi J Gray
Ph: 206-616-8289

Seattle Cancer Care Alliance

Heidi J Gray
Ph: 206-616-8289

Swedish Cancer Institute at Northwest Hospital & Medical Center

Heidi J Gray
Ph: 206-616-8289

University Cancer Center at University of Washington Medical Center

Heidi J Gray
Ph: 206-616-8289

Women's Cancer Center of Seattle

Heidi J Gray
Ph: 206-616-8289

Tacoma

MultiCare Regional Cancer Center at Tacoma General Hospital

John A Keech
Ph: 907-458-5380

West Virginia
Morgantown

Monongalia General Hospital

Jamie L Lesnock
Ph: 888-823-5923
Email: ctsucontact@westat.com

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

Madison

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Lisa M Barroilhet
Ph: 877-405-6866

Manitowoc

Holy Family Memorial Medical Center Cancer Care Center

Jonathan E Tammela
Ph: 920-433-8889

Milwaukee

Froedtert Hospital and Medical College of Wisconsin

William H Bradley
Ph: 414-805-4380

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

Wausau

University of Wisconcin Cancer Center at Aspirus Wausau Hospital

Christopher G Peterson
Ph: 877-405-6866

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT02065687
ClinicalTrials.gov processed this data on December 23, 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.