Dactinomycin or Methotrexate in Treating Patients with Low-Risk Gestational Trophoblastic Neoplasia

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase IIITreatmentActive18 and overGOG-0275
NCI-2012-00250, CDR0000725211, PGOG-0275_A08PAMDREVW01, NCT01535053

Trial Description

Summary

This randomized phase III trial studies how well methotrexate works compared to dactinomycin in treating patients with low-risk gestational trophoblastic neoplasia. Drugs used in chemotherapy, such as methotrexate and dactinomycin, 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. It is not yet known whether methotrexate is more effective than dactinomycin in treating gestational trophoblastic disease.

Further Study Information

PRIMARY OBJECTIVES:

I. To test the hypothesis that treatment with multi-day methotrexate is inferior to treatment with pulse actinomycin-D (dactinomycin) in patients with low-risk gestational trophoblastic disease with respect to complete response.

SECONDARY OBJECTIVES:

I. To describe the frequency of post protocol surgical treatment for each arm.

II. To describe the frequency of post protocol multi-agent chemotherapy treatment for each arm.

III. To compare multi-day methotrexate to actinomycin-D with respect to frequency and severity of adverse events in patients with low-risk gestational trophoblastic neoplasia.

IV. To investigate the impact of treatment on overall quality-of-life (QOL) and explore the influence of treatment on issues such as body image, sexual functioning, and patient-reported side effects and disruption.

V. To assess whether uterine artery pulsatility index (UAPI) can provide independent prognostic information predictive of single-drug resistance.

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

ARM I: Patients receive dactinomycin intravenously (IV) over 15 minutes on day 1.

ARM II: Patients receive methotrexate intramuscularly (IM) on days 1, 3, 5, and 7 and leucovorin calcium orally (PO) on days 2, 4, 6, and 8 OR single agent methotrexate IV on days 1-5.

In both arms, treatment repeats every 14 days for up to 20 courses* in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up monthly for 1 year and then every 3 months for 1 year.

NOTE: * Patients will be treated for three courses after human chorionic gonadotropin (hCG) < 5 mIU/mL or until evidence of treatment failure (biologic progression), disease progression, or unacceptable toxicity despite dose modifications. Upon normalization of hCG (< 5 mIU/mL), patients will be treated with three additional courses.

Eligibility Criteria

Inclusion Criteria:

Patients who meet International Federation of Gynecology and Obstetrics (FIGO) stage I, II, or III criteria for low-risk gestational trophoblastic neoplasia (GTN): post molar GTN or choriocarcinoma (as defined below); patients may have had a second curettage but must still meet GTN criteria below:

Post molar GTN

  • For the purposes of this study, patients must have undergone evacuation of a complete or partial hydatidiform mole and then meet the criteria for GTN defined as:

*** A < 10% decrease in the hCG level using as a reference the first value in the series of 4 values taken over a period of 3 weeks (> 50 mIU/ml minimum) OR

*** A > 20% sustained rise in the hCG taking as a reference the first value in the series of 3 values taken over a period of 2 weeks (> 50 mIU/ml minimum) OR

*** A persistently elevated hCG level a period of 6 months or more following the initial curettage (> 50 mIU/ml minimum)

Choriocarcinoma

  • Histologically proven non-metastatic choriocarcinoma OR
  • Histologically proven metastatic choriocarcinoma if the metastatic site(s) is restricted to one (or more) of the following: vagina, parametrium, or lung

World Health Organization (WHO) risk score 0-6

Patients must be willing to practice effective contraception for the duration of the study

White blood cell count (WBC) >= 3,000 cells/mcL

Granulocytes >= 1,500/mcL

Platelets >= 100,000/mcL

Creatinine =< 2.0 mg/dcL

Bilirubin =< 1.5 x institutional normal

Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x institutional normal

Alkaline phosphatase =< 3 x institutional normal

Patients who have met the pre-entry requirements

Before enrolling a patient, the institution must verify the availability of an adequate supply of methotrexate for a full course of therapy

Patients must have signed an approved informed consent and authorization permitting release of personal health information

Exclusion Criteria:

Patients who do not have GTN

Patients with non-gestational choriocarcinoma

Patients who have previously been treated with cytotoxic chemotherapy; however, patients who received prior low-dose methotrexate for treatment of an ectopic pregnancy will be eligible for this study

Patients who have received prior pelvic radiation

Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)

Patients with Gynecologic Oncology Group (GOG) performance status of 3 or 4

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 five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy

Patients whose circumstances at the time of study entry do not permit completion of the study or required follow-up

Patients who wish to breast-feed during treatment

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

NRG Oncology

  • National Cancer Institute
Julian C. Schink, Principal Investigator

Trial Sites

U.S.A.

Alaska
Anchorage

Alaska Breast Care and Surgery LLC

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Alaska Oncology and Hematology LLC

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Alaska Women's Cancer Care

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Anchorage Oncology Centre

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Anchorage Radiation Therapy Center

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Katmai Oncology Group

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Providence Alaska Medical Center

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Arizona
Phoenix

Saint Joseph's Hospital and Medical Center

John Hall Farley
Ph: 877-602-4111

John Hall Farley
Principal Investigator

University of Arizona Cancer Center at Saint Joseph's

John Hall Farley
Ph: 602-798-0807
Email: john.farley@dignityhealth.org

John Hall Farley
Principal Investigator

California
Burbank

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Loma Linda

Loma Linda University Medical Center

Yevgeniya Jane Mikhailovn Ioffe
Ph: 909-558-0702
Email: yioffe@llu.edu

Yevgeniya Jane Mikhailovn Ioffe
Principal Investigator

Los Angeles

Kaiser Permanente Los Angeles Medical Center

Scott E. Lentz
Ph: 323-783-4736
Email: scott.e.lentz@kp.org

Scott E. Lentz
Principal Investigator

Connecticut
Hartford

Hartford Hospital

James S. Hoffman
Ph: 860-224-5660

James S. Hoffman
Principal Investigator

New Britain

The Hospital of Central Connecticut

James S. Hoffman
Ph: 860-224-5660

James S. Hoffman
Principal Investigator

Georgia
Atlanta

Northside Hospital

Guilherme Henrique C. Cantuaria
Ph: 404-300-2986
Email: clinicaltrials@northside.com

Guilherme Henrique C. Cantuaria
Principal Investigator

Augusta

Georgia Regents University Medical Center

Sharad Anant Ghamande
Ph: 706-721-4212
Email: cancer@georgiahealth.edu

Sharad Anant Ghamande
Principal Investigator

Cumming

Northside Hospital-Forsyth

Guilherme Henrique C. Cantuaria
Ph: 404-300-2986
Email: clinicaltrials@northside.com

Guilherme Henrique C. Cantuaria
Principal Investigator

Gainesville

Northeast Georgia Medical Center

Andrew Emmons Green
Ph: 770-219-8800
Email: cancerpatient.navigator@nghs.com

Andrew Emmons Green
Principal Investigator

Savannah

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

William Edward Richards
Ph: 800-622-6877

William Edward Richards
Principal Investigator

Low Country Cancer Care Associates PC

James Joseph Burke
Ph: 912-350-3932
Email: burkeja1@memorialhealth.com

James Joseph Burke
Principal Investigator

Memorial University Medical Center

James Joseph Burke
Ph: 912-350-3932
Email: burkeja1@memorialhealth.com

James Joseph Burke
Principal Investigator

Summit Cancer Care-Memorial

James Joseph Burke
Ph: 912-350-3932
Email: burkeja1@memorialhealth.com

James Joseph Burke
Principal Investigator

Idaho
Boise

Saint Luke's Mountain States Tumor Institute

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Coeur D'Alene

Kootenai Medical Center

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Fruitland

Saint Luke's Mountain States Tumor Institute - Fruitland

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Meridian

Saint Luke's Mountain States Tumor Institute - Meridian

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Nampa

Saint Luke's Mountain States Tumor Institute - Nampa

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Post Falls

Kootenai Cancer Center

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Sandpoint

Kootenai Cancer

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Twin Falls

Saint Luke's Mountain States Tumor Institute-Twin Falls

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Illinois
Aurora

Rush - Copley Medical Center

Kendrith M. Rowland
Ph: 217-383-3466
Email: kendrith.rowland@carle.com

Kendrith M. Rowland
Principal Investigator

Chicago

Northwestern University

Shohreh Shahabi
Ph: 312-472-4688
Email: cancer@northwestern.edu

Shohreh Shahabi
Principal Investigator

University of Chicago Comprehensive Cancer Center

Seiko Diane Yamada
Ph: 773-834-7424
Email: sdyamada@bsd.uchicago.edu

Seiko Diane Yamada
Principal Investigator

Danville

Carle on Vermilion

Kendrith M. Rowland
Ph: 217-383-3466
Email: kendrith.rowland@carle.com

Kendrith M. Rowland
Principal Investigator

Effingham

Carle Physician Group-Effingham

Kendrith M. Rowland
Ph: 217-383-3466
Email: kendrith.rowland@carle.com

Kendrith M. Rowland
Principal Investigator

Evanston

NorthShore University HealthSystem-Evanston Hospital

Jean A. Hurteau
Ph: 847-733-5358
Email: jhurteau@northshore.org

Jean A. Hurteau
Principal Investigator

Glenview

NorthShore University HealthSystem-Glenbrook Hospital

Jean A. Hurteau
Ph: 847-733-5358
Email: jhurteau@northshore.org

Jean A. Hurteau
Principal Investigator

Highland Park

NorthShore University HealthSystem-Highland Park Hospital

Jean A. Hurteau
Ph: 847-733-5358
Email: jhurteau@northshore.org

Jean A. Hurteau
Principal Investigator

Hinsdale

Sudarshan K Sharma MD Limted-Gynecologic Oncology

Sudarshan K. Sharma
Ph: 630-856-6757

Sudarshan K. Sharma
Principal Investigator

Mattoon

Carle Physician Group-Mattoon/Charleston

Kendrith M. Rowland
Ph: 217-383-3466
Email: kendrith.rowland@carle.com

Kendrith M. Rowland
Principal Investigator

New Lenox

UC Comprehensive Cancer Center at Silver Cross

Seiko Diane Yamada
Ph: 773-834-7424
Email: sdyamada@bsd.uchicago.edu

Seiko Diane Yamada
Principal Investigator

Skokie

North Shore Medical Center

Jean A. Hurteau
Ph: 847-733-5358
Email: jhurteau@northshore.org

Jean A. Hurteau
Principal Investigator

Urbana

Carle Cancer Center

Kendrith M. Rowland
Ph: 217-383-3466
Email: kendrith.rowland@carle.com

Kendrith M. Rowland
Principal Investigator

The Carle Foundation Hospital

Kendrith M. Rowland
Ph: 217-383-3466
Email: kendrith.rowland@carle.com

Kendrith M. Rowland
Principal Investigator

Yorkville

Rush-Copley Healthcare Center

Kendrith M. Rowland
Ph: 217-383-3466
Email: kendrith.rowland@carle.com

Kendrith M. Rowland
Principal Investigator

Indiana
Indianapolis

Saint Vincent Hospital and Health Care Center

Michael J. Callahan
Ph: 317-415-6749
Email: research@stvincent.org

Michael J. Callahan
Principal Investigator

Michigan City

Franciscan Saint Anthony Health-Michigan City

Kendrith M. Rowland
Ph: 217-383-3466
Email: kendrith.rowland@carle.com

Kendrith M. Rowland
Principal Investigator

Woodland Cancer Care Center

Kendrith M. Rowland
Ph: 217-383-3466
Email: kendrith.rowland@carle.com

Kendrith M. Rowland
Principal Investigator

Mishawaka

Memorial Regional Cancer Center Day Road

Nonyem A. Onujiogu
Ph: 574-647-4235
Email: nonujiogu@beaconhealthsystem.org

Nonyem A. Onujiogu
Principal Investigator

Saint Joseph Regional Medical Center-Mishawaka

Eduardo Braun
Ph: 219-785-3400

Eduardo Braun
Principal Investigator

South Bend

Memorial Hospital of South Bend

Nonyem A. Onujiogu
Ph: 574-647-4235
Email: nonujiogu@beaconhealthsystem.org

Nonyem A. Onujiogu
Principal Investigator

Michiana Hematology Oncology PC-South Bend

Eduardo Braun
Ph: 219-785-3400

Eduardo Braun
Principal Investigator

Northern Indiana Cancer Research Consortium CCOP

Michael W. Method
Ph: 574-237-1328

Michael W. Method
Principal Investigator

Iowa
Sioux City

Siouxland Regional Cancer Center

Donald B. Wender
Ph: 712-252-0088

Donald B. Wender
Principal Investigator

Kentucky
Edgewood

Saint Elizabeth Medical Center South

James Clifford Pavelka
Ph: 513-862-2230

James Clifford Pavelka
Principal Investigator

Maine
Scarborough

Maine Medical Center- Scarborough Campus

Christopher J. Darus
Ph: 207-885-7565

Christopher J. Darus
Principal Investigator

Maryland
Bethesda

Walter Reed National Military Medical Center

William J. Lowery
Ph: 301-400-1307
Email: william.j.lowery20.mil@mail.mil

William J. Lowery
Principal Investigator

Massachusetts
Boston

Brigham and Women's Hospital

Neil Stuart Horowitz
Ph: 617-724-5200

Neil Stuart Horowitz
Principal Investigator

Dana-Farber/Harvard Cancer Center

Neil Stuart Horowitz
Ph: 617-724-5200

Neil Stuart Horowitz
Principal Investigator

Michigan
Battle Creek

Bronson Battle Creek

Kathleen J. Yost
Ph: 616-954-2116
Email: connie.szczepanek@grcop.org

Kathleen J. Yost
Principal Investigator

Grand Rapids

Mercy Health Saint Mary's

Kathleen J. Yost
Ph: 616-954-2116
Email: connie.szczepanek@grcop.org

Kathleen J. Yost
Principal Investigator

Spectrum Health at Butterworth Campus

Kathleen J. Yost
Ph: 616-954-2116
Email: connie.szczepanek@grcop.org

Kathleen J. Yost
Principal Investigator

Kalamazoo

Borgess Medical Center

Kathleen J. Yost
Ph: 616-954-2116
Email: connie.szczepanek@grcop.org

Kathleen J. Yost
Principal Investigator

Bronson Methodist Hospital

Kathleen J. Yost
Ph: 616-954-2116
Email: connie.szczepanek@grcop.org

Kathleen J. Yost
Principal Investigator

West Michigan Cancer Center

Kathleen J. Yost
Ph: 616-391-1230
Email: connie.szczepanek@grcop.org

Kathleen J. Yost
Principal Investigator

Muskegon

Mercy Health Mercy Campus

Kathleen J. Yost
Ph: 616-954-2116
Email: connie.szczepanek@grcop.org

Kathleen J. Yost
Principal Investigator

Niles

Lakeland Community Hospital

Kathleen J. Yost
Ph: 616-954-2116
Email: connie.szczepanek@grcop.org

Kathleen J. Yost
Principal Investigator

Reed City

Spectrum Health Reed City Hospital

Kathleen J. Yost
Ph: 616-954-2116
Email: connie.szczepanek@grcop.org

Kathleen J. Yost
Principal Investigator

Saint Joseph

Marie Yeager Cancer Center

Kathleen J. Yost
Ph: 616-954-2116
Email: connie.szczepanek@grcop.org

Kathleen J. Yost
Principal Investigator

St. Joseph

Lakeland Hospital

Kathleen J. Yost
Ph: 616-954-2116
Email: connie.szczepanek@grcop.org

Kathleen J. Yost
Principal Investigator

Traverse City

Munson Medical Center

Kathleen J. Yost
Ph: 616-954-2116
Email: connie.szczepanek@grcop.org

Kathleen J. Yost
Principal Investigator

Minnesota
Burnsville

Fairview Ridges Hospital

Matthew P. Boente
Ph: 952-993-1550
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Coon Rapids

Mercy Hospital

Matthew P. Boente
Ph: 952-993-1550
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Edina

Fairview-Southdale Hospital

Matthew P. Boente
Ph: 952-993-1550
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Fridley

Unity Hospital

Matthew P. Boente
Ph: 952-993-1550
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Maplewood

Minnesota Oncology Hematology PA-Maplewood

Matthew P. Boente
Ph: 952-993-1550
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Saint John's Hospital - Healtheast

Matthew P. Boente
Ph: 952-993-1550
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Minneapolis

Abbott-Northwestern Hospital

Matthew P. Boente
Ph: 952-993-1550
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Health Partners Inc

Matthew P. Boente
Ph: 952-993-1550
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Hennepin County Medical Center

Matthew P. Boente
Ph: 952-993-1550
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

New Ulm

New Ulm Medical Center

Matthew P. Boente
Ph: 952-993-1550
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Robbinsdale

North Memorial Medical Health Center

Matthew P. Boente
Ph: 952-993-1550
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Saint Louis Park

Park Nicollet Clinic - Saint Louis Park

Matthew P. Boente
Ph: 952-993-1550
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Saint Paul

Regions Hospital

Matthew P. Boente
Ph: 952-993-1550
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

United Hospital

Matthew P. Boente
Ph: 952-993-1550
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Shakopee

Saint Francis Regional Medical Center

Matthew P. Boente
Ph: 952-993-1550
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Stillwater

Lakeview Hospital

Matthew P. Boente
Ph: 952-993-1550
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Waconia

Ridgeview Medical Center

Matthew P. Boente
Ph: 952-993-1550
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Willmar

Rice Memorial Hospital

Matthew P. Boente
Ph: 952-993-1550
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Woodbury

Minnesota Oncology and Hematology PA-Woodbury

Matthew P. Boente
Ph: 952-993-1550
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Missouri
Saint Louis

Barnes-Jewish Hospital

David Gardner Mutch
Ph: 314-362-2893
Email: info@ccadmin.wustl.edu

David Gardner Mutch
Principal Investigator

Washington University School of Medicine

David Gardner Mutch
Ph: 314-362-2893
Email: info@ccadmin.wustl.edu

David Gardner Mutch
Principal Investigator

Springfield

CoxHealth South Hospital

Jay W. Carlson
Ph: 417-820-3587
Email: jay.carlson@mercy.net

Jay W. Carlson
Principal Investigator

Mercy Hospital Springfield

Jay W. Carlson
Ph: 417-820-3587
Email: jay.carlson@mercy.net

Jay W. Carlson
Principal Investigator

Montana
Anaconda

Community Hospital of Anaconda

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Billings

Billings Clinic Cancer Center

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Montana Cancer Consortium NCORP

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Saint Vincent Healthcare

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Bozeman

Bozeman Deaconess Hospital

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Butte

Saint James Community Hospital and Cancer Treatment Center

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Great Falls

Benefis Healthcare- Sletten Cancer Institute

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Great Falls Clinic

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Helena

Saint Peter's Community Hospital

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Kalispell

Kalispell Regional Medical Center

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Missoula

Community Medical Hospital

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Saint Patrick Hospital - Community Hospital

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Nevada
Las Vegas

Women's Cancer Center of Nevada

Nicola M. Spirtos
Ph: 702-851-4672

Nicola M. Spirtos
Principal Investigator

New Mexico
Albuquerque

Southwest Gynecologic Oncology Associates Inc

Carolyn Y. Muller
Ph: 505-925-0454
Email: cmuller@salud.unm.edu

Carolyn Y. Muller
Principal Investigator

University of New Mexico Cancer Center

Carolyn Y. Muller
Ph: 505-925-0454
Email: cmuller@salud.unm.edu

Carolyn Y. Muller
Principal Investigator

New York
Brooklyn

State University of New York Downstate Medical Center

Ovadia Abulafia
Ph: 718-270-8216
Email: sima.terebelo@downstate.edu

Ovadia Abulafia
Principal Investigator

North Carolina
Winston-Salem

Wake Forest University Health Sciences

Samuel Smith Lentz
Ph: 336-716-4334
Email: slentz@wakehealth.edu

Samuel Smith Lentz
Principal Investigator

Ohio
Belpre

Strecker Cancer Center-Belpre

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

John Philip Kuebler
Principal Investigator

Chillicothe

Adena Regional Medical Center

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

John Philip Kuebler
Principal Investigator

Cincinnati

Bethesda North Hospital

James Clifford Pavelka
Ph: 513-862-2230

James Clifford Pavelka
Principal Investigator

Good Samaritan Hospital - Cincinnati

James Clifford Pavelka
Ph: 513-862-2230

James Clifford Pavelka
Principal Investigator

Cleveland

Cleveland Clinic Cancer Center/Fairview Hospital

Peter G. Rose
Ph: 216-444-8551
Email: rosep@ccf.org

Peter G. Rose
Principal Investigator

Cleveland Clinic Foundation

Peter G. Rose
Ph: 216-444-8551
Email: rosep@ccf.org

Peter G. Rose
Principal Investigator

Columbus

Columbus Oncology and Hematology Associates Inc

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

John Philip Kuebler
Principal Investigator

Doctors Hospital

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

John Philip Kuebler
Principal Investigator

Grant Medical Center

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

John Philip Kuebler
Principal Investigator

Mount Carmel Health Center West

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

John Philip Kuebler
Principal Investigator

Ohio State University Comprehensive Cancer Center

David M. O'Malley
Ph: 614-366-7942
Email: Jamesline@osumc.edu

David M. O'Malley
Principal Investigator

Riverside Methodist Hospital

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

John Philip Kuebler
Principal Investigator

The Mark H Zangmeister Center

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

John Philip Kuebler
Principal Investigator

Delaware

Delaware Health Center-Grady Cancer Center

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

John Philip Kuebler
Principal Investigator

Delaware Radiation Oncology

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

John Philip Kuebler
Principal Investigator

Grady Memorial Hospital

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

John Philip Kuebler
Principal Investigator

Lancaster

Fairfield Medical Center

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

John Philip Kuebler
Principal Investigator

Marietta

Marietta Memorial Hospital

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

John Philip Kuebler
Principal Investigator

Mayfield Heights

Hillcrest Hospital Cancer Center

Peter G. Rose
Ph: 216-444-8551
Email: rosep@ccf.org

Peter G. Rose
Principal Investigator

Mount Vernon

Knox Community Hospital

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

John Philip Kuebler
Principal Investigator

Newark

Licking Memorial Hospital

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

John Philip Kuebler
Principal Investigator

Newark Radiation Oncology

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

John Philip Kuebler
Principal Investigator

Portsmouth

Southern Ohio Medical Center

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

John Philip Kuebler
Principal Investigator

Westerville

Saint Ann's Hospital

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

John Philip Kuebler
Principal Investigator

Zanesville

Genesis Healthcare System Cancer Care Center

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

John Philip Kuebler
Principal Investigator

Oklahoma
Oklahoma City

University of Oklahoma Health Sciences Center

Robert S. Mannel
Ph: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Robert S. Mannel
Principal Investigator

Tulsa

Oklahoma Cancer Specialists and Research Institute-Tulsa

Robert S. Mannel
Ph: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Robert S. Mannel
Principal Investigator

Oregon
Bend

Saint Charles Medical Center-Bend

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Clackamas

Clackamas Radiation Oncology Center

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Providence Oncology and Hematology Care Southeast

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Coos Bay

Bay Area Hospital

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Newberg

Providence Newberg Medical Center

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Oregon City

Providence Willamette Falls Medical Center

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Portland

Providence Portland Medical Center

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Providence Saint Vincent Medical Center

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Pennsylvania
Abington

Abington Memorial Hospital

Parviz Hanjani
Ph: 215-576-0740
Email: phanjani@amh.org

Parviz Hanjani
Principal Investigator

Beaver

UPMC-Heritage Valley Health System Beaver

Alexander Babatunde Olawaiye
Ph: 412-641-5417
Email: olawaiyea@mail.magee.edu

Alexander Babatunde Olawaiye
Principal Investigator

Danville

Geisinger Medical Center

Radhika P. Gogoi
Ph: 570-271-5841
Email: rpgogoi@geisinger.edu

Radhika P. Gogoi
Principal Investigator

Greensburg

UPMC Cancer Centers - Arnold Palmer Pavilion

Alexander Babatunde Olawaiye
Ph: 412-641-5417
Email: olawaiyea@mail.magee.edu

Alexander Babatunde Olawaiye
Principal Investigator

Hazleton

Geisinger Medical Center-Cancer Center Hazleton

Radhika P. Gogoi
Ph: 570-271-5841
Email: rpgogoi@geisinger.edu

Radhika P. Gogoi
Principal Investigator

Johnstown

UPMC-Johnstown/John P. Murtha Regional Cancer Center

Alexander Babatunde Olawaiye
Ph: 412-641-5417
Email: olawaiyea@mail.magee.edu

Alexander Babatunde Olawaiye
Principal Investigator

McKeesport

UPMC Cancer Center at UPMC McKeesport

Alexander Babatunde Olawaiye
Ph: 412-641-5417
Email: olawaiyea@mail.magee.edu

Alexander Babatunde Olawaiye
Principal Investigator

Moon Township

UPMC-Coraopolis/Heritage Valley Radiation Oncology

Alexander Babatunde Olawaiye
Ph: 412-641-5417
Email: olawaiyea@mail.magee.edu

Alexander Babatunde Olawaiye
Principal Investigator

Philadelphia

Temple University Hospital

Enrique Hernandez
Ph: 215-728-2983

Enrique Hernandez
Principal Investigator

Pittsburgh

University of Pittsburgh Cancer Institute (UPCI)

Alexander Babatunde Olawaiye
Ph: 412-641-5417
Email: olawaiyea@mail.magee.edu

Alexander Babatunde Olawaiye
Principal Investigator

UPMC Jefferson Regional Radiation Oncology

Alexander Babatunde Olawaiye
Ph: 412-641-5417
Email: olawaiyea@mail.magee.edu

Alexander Babatunde Olawaiye
Principal Investigator

UPMC-Magee Womens Hospital

Alexander Babatunde Olawaiye
Ph: 412-641-5417
Email: olawaiyea@mail.magee.edu

Alexander Babatunde Olawaiye
Principal Investigator

UPMC-Passavant Hospital

Alexander Babatunde Olawaiye
Ph: 412-641-5417
Email: olawaiyea@mail.magee.edu

Alexander Babatunde Olawaiye
Principal Investigator

UPMC-Presbyterian Hospital

Alexander Babatunde Olawaiye
Ph: 412-641-5417
Email: olawaiyea@mail.magee.edu

Alexander Babatunde Olawaiye
Principal Investigator

UPMC-Saint Clair Hospital Cancer Center

Alexander Babatunde Olawaiye
Ph: 412-641-5417
Email: olawaiyea@mail.magee.edu

Alexander Babatunde Olawaiye
Principal Investigator

UPMC-Saint Margaret

Alexander Babatunde Olawaiye
Ph: 412-641-5417
Email: olawaiyea@mail.magee.edu

Alexander Babatunde Olawaiye
Principal Investigator

UPMC-Shadyside Hospital

Alexander Babatunde Olawaiye
Ph: 412-641-5417
Email: olawaiyea@mail.magee.edu

Alexander Babatunde Olawaiye
Principal Investigator

Seneca

UPMC Cancer Center at UPMC Northwest

Alexander Babatunde Olawaiye
Ph: 412-641-5417
Email: olawaiyea@mail.magee.edu

Alexander Babatunde Olawaiye
Principal Investigator

State College

Geisinger Medical Group

Radhika P. Gogoi
Ph: 570-271-5841
Email: rpgogoi@geisinger.edu

Radhika P. Gogoi
Principal Investigator

Uniontown

UPMC Uniontown Hospital Radiation Oncology

Alexander Babatunde Olawaiye
Ph: 412-641-5417
Email: olawaiyea@mail.magee.edu

Alexander Babatunde Olawaiye
Principal Investigator

Washington

UPMC Washington Hospital Radiation Oncology

Alexander Babatunde Olawaiye
Ph: 412-641-5417
Email: olawaiyea@mail.magee.edu

Alexander Babatunde Olawaiye
Principal Investigator

West Reading

Reading Hospital

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

Bernice L. Robinson-Bennett
Principal Investigator

Wilkes-Barre

Geisinger Wyoming Valley/Henry Cancer Center

Radhika P. Gogoi
Ph: 570-271-5841
Email: rpgogoi@geisinger.edu

Radhika P. Gogoi
Principal Investigator

Rhode Island
Providence

Women and Infants Hospital

Carolyn Kay McCourt
Ph: 800-600-3606
Email: info@siteman.wustl.edu

Carolyn Kay McCourt
Principal Investigator

South Carolina
Greenville

Saint Francis Cancer Center

David Griffin
Ph: 864-225-2592
Email: david_griffin@bshsi.org

David Griffin
Principal Investigator

Saint Francis Hospital

David Griffin
Ph: 864-225-2592
Email: david_griffin@bshsi.org

David Griffin
Principal Investigator

Texas
Austin

University Medical Center Brackenridge

Alka Mallik
Ph: 512-324-7991

Alka Mallik
Principal Investigator

Dallas

Parkland Memorial Hospital

David Scott Miller
Ph: 214-648-8404
Email: David.Miller@utsouthwestern.edu

David Scott Miller
Principal Investigator

UT Southwestern/Simmons Cancer Center-Dallas

David Scott Miller
Ph: 214-648-8404
Email: David.Miller@utsouthwestern.edu

David Scott Miller
Principal Investigator

Washington
Aberdeen

Providence Regional Cancer System-Aberdeen

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Anacortes

Cancer Care Center at Island Hospital

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Bellevue

Swedish Cancer Institute-Eastside Oncology Hematology

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Bellingham

PeaceHealth Saint Joseph Medical Center

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Centralia

Providence Regional Cancer System-Centralia

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Edmonds

Swedish Medical Center-Edmonds

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Everett

Providence Regional Cancer Partnership

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Issaquah

Swedish Cancer Institute-Issaquah

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Lacey

Providence Regional Cancer System-Lacey

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Longview

Saint John Medical Center

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Seattle

Group Health Cooperative-Seattle

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Minor and James Medical PLLC

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Pacific Gynecology Specialists

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Swedish Medical Center-Ballard Campus

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Swedish Medical Center-First Hill

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Shelton

Providence Regional Cancer System-Shelton

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Spokane

Rockwood Cancer Treatment Center-DHEC-Downtown

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Spokane Valley

Rockwood Clinic Cancer Treatment Center-Valley

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Vancouver

PeaceHealth Southwest Medical Center

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Walla Walla

Providence Saint Mary Regional Cancer Center

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Yakima

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

Yelm

Providence Regional Cancer System-Yelm

Paul G. Montgomery
Ph: 208-381-3124
Email: montgomp@slhs.org

Paul G. Montgomery
Principal Investigator

West Virginia
Morgantown

Monongalia Hospital

Jamie L. Lesnock
Ph: 304-598-6566
Email: lesnockj@monhealthsys.org

Jamie L. Lesnock
Principal Investigator

Wisconsin
Burlington

Aurora Cancer Care-Burlington

Elizabeth Louise Dickson Michelson
Ph: 414-329-5939
Email: elizabeth.dickson@aurora.org

Elizabeth Louise Dickson Michelson
Principal Investigator

Elkhorn

Aurora Cancer Care-Southern Lakes

Elizabeth Louise Dickson Michelson
Ph: 414-329-5939
Email: elizabeth.dickson@aurora.org

Elizabeth Louise Dickson Michelson
Principal Investigator

Fond Du Lac

Aurora Health Center-Fond du Lac

Elizabeth Louise Dickson Michelson
Ph: 414-329-5939
Email: elizabeth.dickson@aurora.org

Elizabeth Louise Dickson Michelson
Principal Investigator

Grafton

Aurora Cancer Care-Grafton

Elizabeth Louise Dickson Michelson
Ph: 414-329-5939
Email: elizabeth.dickson@aurora.org

Elizabeth Louise Dickson Michelson
Principal Investigator

Green Bay

Aurora BayCare Medical Center

Elizabeth Louise Dickson Michelson
Ph: 414-329-5939
Email: elizabeth.dickson@aurora.org

Elizabeth Louise Dickson Michelson
Principal Investigator

Kenosha

Aurora Cancer Care-Kenosha South

Elizabeth Louise Dickson Michelson
Ph: 414-329-5939
Email: elizabeth.dickson@aurora.org

Elizabeth Louise Dickson Michelson
Principal Investigator

Marinette

Vince Lombardi Cancer Clinic-Marinette

Elizabeth Louise Dickson Michelson
Ph: 414-329-5939
Email: elizabeth.dickson@aurora.org

Elizabeth Louise Dickson Michelson
Principal Investigator

Menomonee Falls

Aurora Advanced Healthcare Inc-Menomonee Falls

Elizabeth Louise Dickson Michelson
Ph: 414-329-5939
Email: elizabeth.dickson@aurora.org

Elizabeth Louise Dickson Michelson
Principal Investigator

Milwaukee

Aurora Cancer Care-Milwaukee

Elizabeth Louise Dickson Michelson
Ph: 414-329-5939
Email: elizabeth.dickson@aurora.org

Elizabeth Louise Dickson Michelson
Principal Investigator

Aurora Cancer Care-Milwaukee South

Ali Mahdavi
Ph: 414-649-5717
Email: ucstudy@uci.edu

Ali Mahdavi
Principal Investigator

Aurora Saint Luke's Medical Center

Elizabeth Louise Dickson Michelson
Ph: 414-329-5939
Email: elizabeth.dickson@aurora.org

Elizabeth Louise Dickson Michelson
Principal Investigator

Aurora Sinai Medical Center

Elizabeth Louise Dickson Michelson
Ph: 414-329-5939
Email: elizabeth.dickson@aurora.org

Elizabeth Louise Dickson Michelson
Principal Investigator

New Richmond

Cancer Center of Western Wisconsin

Matthew P. Boente
Ph: 952-993-1550
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Oshkosh

Vince Lombardi Cancer Clinic - Oshkosh

Elizabeth Louise Dickson Michelson
Ph: 414-329-5939
Email: elizabeth.dickson@aurora.org

Elizabeth Louise Dickson Michelson
Principal Investigator

Racine

Aurora Cancer Care-Racine

Elizabeth Louise Dickson Michelson
Ph: 414-329-5939
Email: elizabeth.dickson@aurora.org

Elizabeth Louise Dickson Michelson
Principal Investigator

Sheboygan

Vince Lombardi Cancer Clinic-Sheboygan

Elizabeth Louise Dickson Michelson
Ph: 414-329-5939
Email: elizabeth.dickson@aurora.org

Elizabeth Louise Dickson Michelson
Principal Investigator

Summit

Aurora Medical Center in Summit

Elizabeth Louise Dickson Michelson
Ph: 414-329-5939
Email: elizabeth.dickson@aurora.org

Elizabeth Louise Dickson Michelson
Principal Investigator

Two Rivers

Vince Lombardi Cancer Clinic

Elizabeth Louise Dickson Michelson
Ph: 414-329-5939
Email: elizabeth.dickson@aurora.org

Elizabeth Louise Dickson Michelson
Principal Investigator

Waukesha

Aurora Cancer Care-Waukesha

Elizabeth Louise Dickson Michelson
Ph: 414-329-5939
Email: elizabeth.dickson@aurora.org

Elizabeth Louise Dickson Michelson
Principal Investigator

Wauwatosa

Aurora Cancer Care-Milwaukee West

Elizabeth Louise Dickson Michelson
Ph: 414-329-5939
Email: elizabeth.dickson@aurora.org

Elizabeth Louise Dickson Michelson
Principal Investigator

West Allis

Aurora West Allis Medical Center

Elizabeth Louise Dickson Michelson
Ph: 414-329-5939
Email: elizabeth.dickson@aurora.org

Elizabeth Louise Dickson Michelson
Principal Investigator

Wyoming
Cody

Big Horn Basin Cancer Center

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Billings Clinic-Cody

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Sheridan

Welch Cancer Center

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

See All Trial Sites

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01535053

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.