Testosterone in Treating Postmenopausal Patients with Arthralgia Caused by Adjuvant Aromatase Inhibitor Treatment

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IIIBiomarker/Laboratory analysis, Supportive care, Treatment18 and overA221102
NCI-2012-00719, CDR0000730083, CALGB-A221102, NCCTG-N10C7, NCT01573442

Trial Description

Summary

This randomized phase III trial studies testosterone to see how well it works compared to placebo in treating postmenopausal patients with arthralgia (joint pain) caused by anastrozole or letrozole. Testosterone may help relieve moderate or severe arthralgia associated with the use of aromatase inhibitors, such as anastrozole or letrozole.

Further Study Information

PRIMARY OBJECTIVES

I. To determine whether testosterone will reduce aromatase inhibitor (AI)-induced arthralgia and associated joint symptoms.

SECONDARY OBJECTIVES:

I. To explore whether testosterone will have an acceptable safety and tolerability profile, with particular reference to androgenic adverse events including acne, hirsutism, and alopecia.

TERTIARY OBJECTIVES:

I. To explore whether testosterone will reduce AI-induced arthralgias and associated joint symptoms and their interference with activity.

II. To explore whether testosterone will reduce the incidence of hot flashes.

III. To explore whether testosterone will modify libido or change quality of life.

IV. To explore whether identified single nucleotide polymorphisms (SNPs), that were associated with more AI-associated arthralgias in a previous prospective trial, are more commonly seen in the patients entered into the present clinical trial, than are observed in the normal population.

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

Arm I: Patients receive testosterone transdermally on day 1 and then at 3 months.

Arm II: Patients receive placebo transdermally on day 1 and then at 3 months.

After completion of study treatment, patients are followed up for 6 months.

Eligibility Criteria

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2

Willing to provide blood samples for correlative research purposes

Ability to complete questionnaire(s) by themselves or with assistance

Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 1.5 x ULN

Hemoglobin > 11 g/dL

Body Mass Index (BMI) between 18 and 35 kg/m^2

White blood cell (WBC) > 3.0

Platelet count > 100,000

Willing to provide informed written consent

Creatinine =< 1.5 x upper limit of normal (ULN)

Willing to return to an Alliance enrolling institution for follow-up

Women who are postmenopausal by surgery, radiotherapy, or presence of natural amenorrhea >= 12 months

Women who have undergone a total mastectomy or breast-conserving surgery for primary breast cancer +/- chemotherapy, +/- radiotherapy

Must have BOTH estrogen receptor (ER) and progesterone receptor (PR)-positive tumors and BOTH must be >= 26% positive; alternatively, if ER and PR are determined by Allred score, the score needs to be 5 or higher

Receiving anastrozole (1 mg) or letrozole (2.5 mg) orally once a day, for >= 21 days prior to registration and plan to continue throughout the duration of study

>= 5/10 arthralgia (in hands, wrist, knees, or hips) while being treated with anastrozole or letrozole which is felt by the patient to be caused by their aromatase inhibitor, as measured by verbally addressing the following question: please rate your pain by picking a number, from 0 to 10 (0 being none and 10 being as bad as you can imagine) that best describes your pain from your aromatase inhibitor breast cancer medication on AVERAGE, over the past week

Note: Patients may, or may not, be taking non-opioid analgesics

Laboratory values obtained =< 365* days prior to registration:

Note: Without medical situations that should change these parameters since they were done

Exclusion Criteria:

History of coronary artery disease (angina or myocardial infarction)

Concurrent use of the aromatase inhibitor exemestane

Prolonged systemic corticosteroid treatment, except for topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airway diseases), eye drops, or local insertion (e.g., intra-articular)

Note: Short duration (< 2 weeks) of systemic corticosteroids is allowed (e.g., for chronic obstructive pulmonary disease), but not within 30 days prior to registration

Diabetes mellitus or glucose intolerance, defined as a fasting glucose > 125 mg/dL

Patients on hormone-replacement therapy (HRT) =< 4 weeks prior to registration; this includes the use of vaginal estrogen therapy

Known hypersensitivity to any component of testosterone

History of a deep venous thrombosis or a thromboembolism

Receiving any other investigational agent

Current or planned use of cyclosporine, anticoagulants, oxyphenbutazone, insulin, oral or injectable vitamin D doses over 4,000 IU/day, or tamoxifen

Concurrent radiation therapy or chemotherapy

Presence of residual or recurrent cancer (locally or metastatic)

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Alliance for Clinical Trials in Oncology

  • National Cancer Institute
Charles Lawrence Loprinzi, Principal Investigator

Trial Sites

U.S.A.

California
Auburn

Sutter Auburn Faith Hospital

Peter Paul Yu
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Peter Paul Yu
Principal Investigator

Sutter Cancer Centers Radiation Oncology Services-Auburn

Peter Paul Yu
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Peter Paul Yu
Principal Investigator

Berkeley

Alta Bates Summit Medical Center-Herrick Campus

Peter Paul Yu
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Peter Paul Yu
Principal Investigator

Burlingame

Mills - Peninsula Hospitals

Peter Paul Yu
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Peter Paul Yu
Principal Investigator

Cameron Park

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Peter Paul Yu
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Peter Paul Yu
Principal Investigator

Castro Valley

Eden Hospital Medical Center

Peter Paul Yu
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Peter Paul Yu
Principal Investigator

Davis

Sutter Davis Hospital

Peter Paul Yu
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Peter Paul Yu
Principal Investigator

Fremont

Washington Hospital

Vandana B. Sharma
Ph: 510-745-6433

Vandana B. Sharma
Principal Investigator

Los Angeles

Cedars-Sinai Medical Center

Armando Elario Giuliano
Ph: 310-423-8965

Armando Elario Giuliano
Principal Investigator

Modesto

Memorial Medical Center

Peter Paul Yu
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Peter Paul Yu
Principal Investigator

Mountain View

Palo Alto Medical Foundation-Camino Division

Peter Paul Yu
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Peter Paul Yu
Principal Investigator

Palo Alto Medical Foundation-Gynecologic Oncology

Peter Paul Yu
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Peter Paul Yu
Principal Investigator

Novato

Sutter Cancer Research Consortium

Peter Paul Yu
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Peter Paul Yu
Principal Investigator

Palo Alto

Palo Alto Medical Foundation Health Care

David Steven Leibowitz
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

David Steven Leibowitz
Principal Investigator

Roseville

Sutter Cancer Centers Radiation Oncology Services-Roseville

Peter Paul Yu
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Peter Paul Yu
Principal Investigator

Sutter Roseville Medical Center

Peter Paul Yu
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Peter Paul Yu
Principal Investigator

Sacramento

Sutter General Hospital

Peter Paul Yu
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Peter Paul Yu
Principal Investigator

San Francisco

California Pacific Medical Center-Pacific Campus

Peter Paul Yu
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Peter Paul Yu
Principal Investigator

Santa Cruz

Palo Alto Medical Foundation-Santa Cruz

Glenn Donald Wong
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Glenn Donald Wong
Principal Investigator

Santa Rosa

Sutter Pacific Medical Foundation

Peter Paul Yu
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Peter Paul Yu
Principal Investigator

Sunnyvale

Palo Atlo Medical Foundation-Sunnyvale

Peter Paul Yu
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Peter Paul Yu
Principal Investigator

Vacaville

Sutter Cancer Centers Radiation Oncology Services-Vacaville

Peter Paul Yu
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Peter Paul Yu
Principal Investigator

Vallejo

Sutter Solano Medical Center/Cancer Center

Peter Paul Yu
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Peter Paul Yu
Principal Investigator

Colorado
Aurora

The Medical Center of Aurora

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Boulder

Boulder Community Hospital

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Rocky Mountain Cancer Centers-Boulder

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Colorado Springs

Penrose-Saint Francis Healthcare

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Rocky Mountain Cancer Centers-Penrose

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Denver

Colorado Blood Cancer Institute

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Colorado Cancer Research Program CCOP

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Exempla Saint Joseph Hospital

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Porter Adventist Hospital

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Presbyterian - Saint Lukes Medical Center - Health One

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Rocky Mountain Cancer Centers-Midtown

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Rocky Mountain Cancer Centers-Rose

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Rose Medical Center

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Durango

Mercy Medical Center

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Englewood

Comprehensive Cancer Care and Research Institute of Colorado LLC

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Swedish Medical Center

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Golden

Mountain Blue Cancer Care Center

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Greeley

North Colorado Medical Center

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Greenwood Village

Rocky Mountain Cancer Centers-Greenwood Village

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Lakewood

Rocky Mountain Cancer Centers-Lakewood

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Saint Anthony Hospital

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Littleton

Littleton Adventist Hospital

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Lone Tree

Rocky Mountain Cancer Centers-Sky Ridge

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Sky Ridge Medical Center

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Longmont

Longmont United Hospital

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Rocky Mountain Cancer Centers-Longmont

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Loveland

McKee Medical Center

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Parker

Parker Adventist Hospital

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Rocky Mountain Cancer Centers-Parker

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Pueblo

Rocky Mountain Cancer Centers - Pueblo

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Saint Mary Corwin Medical Center

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Wheat Ridge

SCL Health Lutheran Medical Center

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Delaware
Lewes

Beebe Medical Center

Stephen Scott Grubbs
Ph: 302-733-6227

Stephen Scott Grubbs
Principal Investigator

Newark

Christiana Care Health System-Christiana Hospital

Stephen Scott Grubbs
Ph: 302-733-6227

Stephen Scott Grubbs
Principal Investigator

Christiana Gynecologic Oncology LLC

Stephen Scott Grubbs
Ph: 302-733-6227

Stephen Scott Grubbs
Principal Investigator

Delaware Clinical and Laboratory Physicians PA

Stephen Scott Grubbs
Ph: 302-733-6227

Stephen Scott Grubbs
Principal Investigator

Helen F Graham Cancer Center

Stephen Scott Grubbs
Ph: 302-733-6227

Stephen Scott Grubbs
Principal Investigator

Medical Oncology Hematology Consultants PA

Stephen Scott Grubbs
Ph: 302-733-6227

Stephen Scott Grubbs
Principal Investigator

Regional Hematology and Oncology PA

Stephen Scott Grubbs
Ph: 302-733-6227

Stephen Scott Grubbs
Principal Investigator

Rehoboth Beach

Beebe Health Campus

Stephen Scott Grubbs
Ph: 302-733-6227

Stephen Scott Grubbs
Principal Investigator

Seaford

Nanticoke Memorial Hospital

Stephen Scott Grubbs
Ph: 302-733-6227

Stephen Scott Grubbs
Principal Investigator

Wilmington

Christiana Care Health System-Wilmington Hospital

Stephen Scott Grubbs
Ph: 302-733-6227

Stephen Scott Grubbs
Principal Investigator

Florida
Lakeland

Lakeland Regional Cancer Center

Madhavi L. Venigalla
Ph: 863-904-1900

Madhavi L. Venigalla
Principal Investigator

Georgia
Atlanta

Northside Hospital

Colleen S. Austin
Ph: 404-303-3355

Colleen S. Austin
Principal Investigator

Columbus

John B Amos Cancer Center

Andrew W. Pippas
Ph: 706-660-6404

Andrew W. Pippas
Principal Investigator

Idaho
Coeur D'Alene

Kootenai Medical Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Post Falls

Kootenai Cancer Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Sandpoint

Kootenai Cancer

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Illinois
Harvey

Ingalls Memorial Hospital

Mark Farrell Kozloff
Ph: 708-915-4673
Email: clinicaltrials@ingalls.org

Mark Farrell Kozloff
Principal Investigator

La Grange

Adventist La Grange Memorial Hospital

James Edward Hannigan
Ph: 800-323-8622

James Edward Hannigan
Principal Investigator

Moline

Garneau, Stewart C MD (UIA Investigator)

David Martens Spector
Ph: 309-779-4200

David Martens Spector
Principal Investigator

Spector, David MD (UIA Investigator)

David Martens Spector
Ph: 309-779-4200

David Martens Spector
Principal Investigator

Trinity Medical Center

David Martens Spector
Ph: 309-779-4200

David Martens Spector
Principal Investigator

Warrenville

Cadence Cancer Center in Warrenville

John D. Ayers
Ph: 630-352-5300

John D. Ayers
Principal Investigator

Indiana
Mishawaka

Memorial Regional Cancer Center Day Road

Thomas Joseph Reid
Ph: 800-284-7370

Thomas Joseph Reid
Principal Investigator

Richmond

Reid Hospital and Health Care Services

Howard M. Gross
Ph: 937-775-1350

Howard M. Gross
Principal Investigator

South Bend

Memorial Hospital of South Bend

Thomas Joseph Reid
Ph: 800-284-7370

Thomas Joseph Reid
Principal Investigator

Iowa
Ames

Mary Greeley Medical Center

Joseph James Merchant
Ph: 515-239-2621

Joseph James Merchant
Principal Investigator

McFarland Clinic PC-William R Bliss Cancer Center

Joseph James Merchant
Ph: 515-239-2621

Joseph James Merchant
Principal Investigator

Bettendorf

Constantinou, Costas L MD (UIA Investigator)

David Martens Spector
Ph: 309-779-4200

David Martens Spector
Principal Investigator

Hematology Oncology Associates-Quad Cities

Shobha R. Chitneni
Ph: 563-355-7733
Email: kedaprile@rccqc.com

Shobha R. Chitneni
Principal Investigator

Boone

McFarland Clinic PC-Boone

Joseph James Merchant
Ph: 515-239-2621

Joseph James Merchant
Principal Investigator

Clive

Medical Oncology and Hematology Associates-West Des Moines

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Mercy Cancer Center-West Lakes

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Council Bluffs

Alegent Health Mercy Hospital

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Des Moines

Medical Oncology and Hematology Associates-Laurel

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Mercy Medical Center - Des Moines

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Fort Dodge

McFarland Clinic PC-Trinity Cancer Center

Joseph James Merchant
Ph: 515-239-2621

Joseph James Merchant
Principal Investigator

Jefferson

McFarland Clinic PC-Jefferson

Joseph James Merchant
Ph: 515-239-2621

Joseph James Merchant
Principal Investigator

Marshalltown

McFarland Clinic PC-Marshalltown

Joseph James Merchant
Ph: 515-239-2621

Joseph James Merchant
Principal Investigator

West Des Moines

Mercy Medical Center-West Lakes

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Kentucky
Bardstown

Flaget Memorial Hospital

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Corbin

Commonwealth Cancer Center-Corbin

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Crestview Hills

Oncology Hematology Care Inc-Crestview

Howard M. Gross
Ph: 937-775-1350

Howard M. Gross
Principal Investigator

Edgewood

Saint Elizabeth Medical Center South

Joseph Michael Guenther
Ph: 859-301-5473
Email: darla.hehman@stelizabeth.com

Joseph Michael Guenther
Principal Investigator

Fort Thomas

Saint Elizabeth Fort Thomas

Joseph Michael Guenther
Ph: 859-301-5473
Email: darla.hehman@stelizabeth.com

Joseph Michael Guenther
Principal Investigator

Lexington

Saint Joseph Hospital East

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Saint Joseph Radiation Oncology Resource Center

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Louisville

Jewish Hospital

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Jewish Hospital Medical Center Northeast

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Saints Mary and Elizabeth Hospital

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Shepherdsville

Jewish Hospital Medical Center South

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Louisiana
Baton Rouge

Ochsner Health Center-Summa

John Thomas Cole
Ph: 888-562-4763

John Thomas Cole
Principal Investigator

New Orleans

Ochsner Baptist Medical Center

John Thomas Cole
Ph: 888-562-4763

John Thomas Cole
Principal Investigator

Ochsner Medical Center Jefferson

John Thomas Cole
Ph: 888-562-4763

John Thomas Cole
Principal Investigator

Maryland
Rockville

Unspecified Site

Charles Lawrence Loprinzi
Ph: 507-284-4849
Email: loprinzi@mayo.edu

Charles Lawrence Loprinzi
Principal Investigator

Massachusetts
Danvers

Mass General/North Shore Cancer Center

Beverly Moy
Ph: 877-726-5130

Beverly Moy
Principal Investigator

Newton

Newton-Wellesley Hospital

Beverly Moy
Ph: 877-726-5130

Beverly Moy
Principal Investigator

Michigan
Escanaba

Green Bay Oncology - Escanaba

Anthony John Jaslowski
Ph: 800-432-6049

Anthony John Jaslowski
Principal Investigator

Iron Mountain

Green Bay Oncology - Iron Mountain

Anthony John Jaslowski
Ph: 800-432-6049

Anthony John Jaslowski
Principal Investigator

Minnesota
Bemidji

Sanford Clinic North-Bemidgi

Preston D. Steen
Ph: 701-234-6161

Preston D. Steen
Principal Investigator

Mankato

Mayo Clinic Health Systems-Mankato

Mohmmad Junaid Ranginwala
Ph: 507-385-2929

Mohmmad Junaid Ranginwala
Principal Investigator

Rochester

Mayo Clinic

Charles Lawrence Loprinzi
Ph: 507-538-7623

Charles Lawrence Loprinzi
Principal Investigator

Missouri
Saint Louis

Washington University School of Medicine

Rebecca L. Aft
Ph: 800-600-3606
Email: info@siteman.wustl.edu

Rebecca L. Aft
Principal Investigator

Montana
Billings

Billings Clinic Cancer Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Montana Cancer Consortium CCOP

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Saint Vincent Healthcare

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Bozeman

Bozeman Deaconess Hospital

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Butte

Saint James Community Hospital and Cancer Treatment Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Great Falls

Benefis Healthcare- Sletten Cancer Institute

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Helena

Saint Peter's Community Hospital

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Kalispell

Kalispell Regional Medical Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Missoula

Community Medical Hospital

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Saint Patrick Hospital - Community Hospital

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Nebraska
Grand Island

CHI Health Saint Francis

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Kearney

CHI Health Good Samaritan

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Heartland Hematology and Oncology

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Lincoln

Saint Elizabeth Regional Medical Center

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Omaha

Alegent Health Bergan Mercy Medical Center

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Alegent Health Immanuel Medical Center

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Alegent Health Lakeside Hospital

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Creighton University Medical Center

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Hemotology and Oncology Consultants PC

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Papillion

Midlands Community Hospital

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Nevada
Henderson

21st Century Oncology - Henderson

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Cancer and Blood Specialists-Henderson

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada - Henderson

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada-Southeast Henderson

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Las Vegas Cancer Center-Henderson

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Las Vegas

21st Century Oncology

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

21st Century Oncology - Fort Apache

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

21st Century Oncology - Vegas Tenaya

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Cancer and Blood Specialists-Fort Apache

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Cancer and Blood Specialists-Shadow

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Cancer and Blood Specialists-Tenaya

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Cancer Therapy and Integrative Medicine

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada - Central Valley

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada - Northwest

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada-Summerlin

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

HealthCare Partners Medical Group Oncology/Hematology-San Martin

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

HealthCare Partners Medical Group Oncology/Hematology-Tenaya

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Las Vegas Cancer Center-Medical Center

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Nevada Cancer Research Foundation CCOP

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Radiation Oncology Centers of Nevada Central

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Radiation Oncology Centers of Nevada Southeast

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

University Medical Center of Southern Nevada

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

New Hampshire
Londonderry

The Dana-Farber Cancer Institute at Londonderry

Beverly Moy
Ph: 877-726-5130

Beverly Moy
Principal Investigator

New Jersey
Englewood

Englewood Hospital and Medical Center

Jill S. Morrison
Ph: 201-894-3456

Jill S. Morrison
Principal Investigator

North Carolina
Charlotte

Carolina Surgical Clinic of Charlotte PA

Justin Peter Favaro
Ph: 704-384-5369

Justin Peter Favaro
Principal Investigator

Novant Health Presbyterian Medical Center

Justin Peter Favaro
Ph: 704-384-5369

Justin Peter Favaro
Principal Investigator

Oncology Specialists of Charlotte

Justin Peter Favaro
Ph: 704-384-5369

Justin Peter Favaro
Principal Investigator

Southern Oncology Specialists-Charlotte

Justin Peter Favaro
Ph: 704-384-5369

Justin Peter Favaro
Principal Investigator

Clinton

Southeastern Medical Oncology Center-Clinton

James N. Atkins
Ph: 919-580-0000

James N. Atkins
Principal Investigator

Goldsboro

Southeastern Medical Oncology Center-Goldsboro

James N. Atkins
Ph: 919-580-0000

James N. Atkins
Principal Investigator

Wayne Memorial Hospital

James N. Atkins
Ph: 919-580-0000

James N. Atkins
Principal Investigator

Huntersville

Lake Norman Hematology Oncology Specialists-Huntersville

Justin Peter Favaro
Ph: 704-384-5369

Justin Peter Favaro
Principal Investigator

Southern Oncology Specialists-Huntersville

Justin Peter Favaro
Ph: 704-384-5369

Justin Peter Favaro
Principal Investigator

Jacksonville

Southeastern Medical Oncology Center-Jacksonville

James N. Atkins
Ph: 919-580-0000

James N. Atkins
Principal Investigator

Kinston

Kinston Medical Specialists PA

Peter Robins Watson
Ph: 252-559-2200

Peter Robins Watson
Principal Investigator

Matthews

Matthews Radiation Oncology Center

Justin Peter Favaro
Ph: 704-384-5369

Justin Peter Favaro
Principal Investigator

Novant Health Cancer Specialists-Matthews

Justin Peter Favaro
Ph: 704-384-5369

Justin Peter Favaro
Principal Investigator

Mooresville

Lake Norman Hematology Oncology Specialists-Mooresville

Justin Peter Favaro
Ph: 704-384-5369

Justin Peter Favaro
Principal Investigator

Wilson

Southeastern Medical Oncology Center-Wilson

James N. Atkins
Ph: 919-580-0000

James N. Atkins
Principal Investigator

North Dakota
Fargo

Roger Maris Cancer Center

Preston D. Steen
Ph: 701-234-6161

Preston D. Steen
Principal Investigator

Sanford Clinic North-Fargo

Preston D. Steen
Ph: 701-234-6161

Preston D. Steen
Principal Investigator

Sanford Medical Center-Fargo

Preston D. Steen
Ph: 701-234-6161

Preston D. Steen
Principal Investigator

Ohio
Centerville

Miami Valley Hospital South

Howard M. Gross
Ph: 937-775-1350

Howard M. Gross
Principal Investigator

Cincinnati

Bethesda North Hospital

Ching Ho
Ph: 513-862-2230

Ching Ho
Principal Investigator

Oncology Hematology Care Inc - Anderson

Howard M. Gross
Ph: 937-775-1350

Howard M. Gross
Principal Investigator

Oncology Hematology Care Inc - Kenwood

Howard M. Gross
Ph: 937-775-1350

Howard M. Gross
Principal Investigator

Oncology Hematology Care Inc-Blue Ash

Howard M. Gross
Ph: 937-775-1350

Howard M. Gross
Principal Investigator

Oncology Hematology Care Inc-Eden Park

Howard M. Gross
Ph: 937-775-1350

Howard M. Gross
Principal Investigator

Oncology Hematology Care Inc-Mercy West

Howard M. Gross
Ph: 937-775-1350

Howard M. Gross
Principal Investigator

TriHealth Cancer Institute-Anderson

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

TriHealth Cancer Institute-Westside

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Dayton

Good Samaritan Hospital - Dayton

Howard M. Gross
Ph: 937-775-1350

Howard M. Gross
Principal Investigator

Miami Valley Hospital

Howard M. Gross
Ph: 937-775-1350

Howard M. Gross
Principal Investigator

Samaritan North Health Center

Howard M. Gross
Ph: 937-775-1350

Howard M. Gross
Principal Investigator

Fairfield

Oncology Hematology Care Inc-Healthplex

Howard M. Gross
Ph: 937-775-1350

Howard M. Gross
Principal Investigator

Findlay

Blanchard Valley Hospital

Howard M. Gross
Ph: 937-775-1350

Howard M. Gross
Principal Investigator

Franklin

Atrium Medical Center-Middletown Regional Hospital

Howard M. Gross
Ph: 937-775-1350

Howard M. Gross
Principal Investigator

Greenville

Wayne Hospital

Howard M. Gross
Ph: 937-775-1350

Howard M. Gross
Principal Investigator

Kettering

Kettering Medical Center

Howard M. Gross
Ph: 937-775-1350

Howard M. Gross
Principal Investigator

Springfield

Springfield Regional Cancer Center

Howard M. Gross
Ph: 937-775-1350

Howard M. Gross
Principal Investigator

Springfield Regional Medical Center

Howard M. Gross
Ph: 937-775-1350

Howard M. Gross
Principal Investigator

Troy

Upper Valley Medical Center

Howard M. Gross
Ph: 937-775-1350

Howard M. Gross
Principal Investigator

Wright-Patterson Afb

Wright-Patterson Medical Center

Brandon James Cutler
Ph: 937-775-1350
Email: som_dcop@wright.edu

Brandon James Cutler
Principal Investigator

Pennsylvania
Sayre

Guthrie Medical Group PC-Robert Packer Hospital

Cynthia Anne Lynch
Ph: 800-836-0388

Cynthia Anne Lynch
Principal Investigator

PR
San Juan

San Juan City Hospital

Luis Baez-Diaz
Ph: 787-767-3733

Luis Baez-Diaz
Principal Investigator

South Carolina
Charleston

Bon Secours Saint Francis Hospital

James Michael Orcutt
Ph: 843-720-8386
Email: elizabeth.strojny@roperstfrancis.com

James Michael Orcutt
Principal Investigator

Charleston Hematology Oncology Associates PA-St. Francis

James Michael Orcutt
Ph: 843-720-8386
Email: elizabeth.strojny@roperstfrancis.com

James Michael Orcutt
Principal Investigator

Charleston Hematology Oncology Associates-Roper

James Michael Orcutt
Ph: 843-720-8386
Email: elizabeth.strojny@roperstfrancis.com

James Michael Orcutt
Principal Investigator

Lowcountry Hematology Oncology PA-Charleston

James Michael Orcutt
Ph: 843-720-8386
Email: elizabeth.strojny@roperstfrancis.com

James Michael Orcutt
Principal Investigator

Lowcountry Hematology Oncology PA-West Ashley

James Michael Orcutt
Ph: 843-720-8386
Email: elizabeth.strojny@roperstfrancis.com

James Michael Orcutt
Principal Investigator

Roper Hospital

James Michael Orcutt
Ph: 843-720-8386
Email: elizabeth.strojny@roperstfrancis.com

James Michael Orcutt
Principal Investigator

Mount Pleasant

Lowcountry Hematology Oncology PA-Mount Pleasant

James Michael Orcutt
Ph: 843-720-8386
Email: elizabeth.strojny@roperstfrancis.com

James Michael Orcutt
Principal Investigator

Tennessee
Bristol

Wellmont Bristol Regional Medical Center

Asheesh Shipstone
Ph: 423-578-8538

Asheesh Shipstone
Principal Investigator

Chattanooga

Memorial Hospital

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Hixson

Pulmonary Medicine Center of Chattanooga-Hixson

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Johnson City

Wellmont Medical Associates Oncology and Hematology-Johnson City

Asheesh Shipstone
Ph: 423-578-8538

Asheesh Shipstone
Principal Investigator

Kingsport

Wellmont Holston Valley Hospital and Medical Center

Asheesh Shipstone
Ph: 423-578-8538

Asheesh Shipstone
Principal Investigator

Wellmont Medical Associates Oncology and Hematology-Kingsport

Asheesh Shipstone
Ph: 423-578-8538

Asheesh Shipstone
Principal Investigator

Ooltewah

Memorial GYN Plus

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Virginia
Fairfax

Medical Oncology Hematology Associates of Northern Virginia Limited

Mary Judith Wilkinson
Ph: 703-720-5210ext1044

Mary Judith Wilkinson
Principal Investigator

Martinsville

Memorial Hospital Of Martinsville

Sreedhar Katragadda
Ph: 276-666-7827

Sreedhar Katragadda
Principal Investigator

Norton

Southwest VA Regional Cancer Center

Asheesh Shipstone
Ph: 423-578-8538

Asheesh Shipstone
Principal Investigator

Washington
Bremerton

Harrison HealthPartners Hematology and Oncology-Bremerton

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Harrison Medical Center

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Burien

Highline Medical Center-Main Campus

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Enumclaw

Saint Elizabeth Hospital

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Federal Way

Saint Francis Hospital

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Lakewood

Saint Clare Hospital

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Poulsbo

Harrison HealthPartners Hematology and Oncology-Poulsbo

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Tacoma

Franciscan Research Center-Northwest Medical Plaza

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Northwest Medical Specialties PLLC

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Wisconsin
Burlington

Aurora Cancer Care-Burlington

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

Eau Claire

Marshfield Clinic Cancer Center at Sacred Heart

Rezwan Islam
Ph: 715-393-1400

Rezwan Islam
Principal Investigator

Elkhorn

Aurora Cancer Care-Southern Lakes

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

Fond Du Lac

Aurora Health Center-Fond du Lac

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

Grafton

Aurora Cancer Care-Grafton

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

Green Bay

Aurora BayCare Medical Center

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

Green Bay Oncology at Saint Vincent Hospital

Anthony John Jaslowski
Ph: 800-432-6049

Anthony John Jaslowski
Principal Investigator

Green Bay Oncology Limited at Saint Mary's Hospital

Anthony John Jaslowski
Ph: 800-432-6049

Anthony John Jaslowski
Principal Investigator

Saint Mary's Hospital

Anthony John Jaslowski
Ph: 800-432-6049

Anthony John Jaslowski
Principal Investigator

Saint Vincent Hospital

Anthony John Jaslowski
Ph: 800-432-6049

Anthony John Jaslowski
Principal Investigator

Kenosha

Aurora Cancer Care-Kenosha South

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

La Crosse

Mayo Clinic Health System-Franciscan Healthcare

Paula Gill
Ph: 608-392-9462

Paula Gill
Principal Investigator

Manitowoc

Holy Family Memorial Hospital

Anthony John Jaslowski
Ph: 800-432-6049

Anthony John Jaslowski
Principal Investigator

Marinette

Bay Area Medical Center

Anthony John Jaslowski
Ph: 800-432-6049

Anthony John Jaslowski
Principal Investigator

Vince Lombardi Cancer Clinic-Marinette

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

Marshfield

Marshfield Clinic

Rezwan Islam
Ph: 715-393-1400

Rezwan Islam
Principal Investigator

Menomonee Falls

Aurora Advanced Healthcare Inc-Menomonee Falls

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

Milwaukee

Aurora Cancer Care-Milwaukee

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

Aurora Cancer Care-Milwaukee South

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

Aurora Saint Luke's Medical Center

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

Aurora Sinai Medical Center

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

Minocqua

Marshfield Clinic-Minocqua Center

Rezwan Islam
Ph: 715-393-1400

Rezwan Islam
Principal Investigator

Oconto Falls

Green Bay Oncology - Oconto Falls

Anthony John Jaslowski
Ph: 800-432-6049

Anthony John Jaslowski
Principal Investigator

Oshkosh

Vince Lombardi Cancer Clinic - Oshkosh

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

Racine

Aurora Cancer Care-Racine

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

Rhinelander

Marshfield Clinic at James Beck Cancer Center

Rezwan Islam
Ph: 715-393-1400

Rezwan Islam
Principal Investigator

Rice Lake

Marshfield Clinic-Rice Lake Center

Rezwan Islam
Ph: 715-393-1400

Rezwan Islam
Principal Investigator

Sheboygan

Saint Nicholas Hospital

Anthony John Jaslowski
Ph: 800-432-6049

Anthony John Jaslowski
Principal Investigator

Vince Lombardi Cancer Clinic-Sheboygan

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

Stevens Point

Marshfield Clinic Cancer Care at Saint Michael's Hospital

Rezwan Islam
Ph: 715-393-1400

Rezwan Islam
Principal Investigator

Sturgeon Bay

Green Bay Oncology - Sturgeon Bay

Anthony John Jaslowski
Ph: 800-432-6049

Anthony John Jaslowski
Principal Investigator

Summit

Aurora Medical Center in Summit

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

Two Rivers

Vince Lombardi Cancer Clinic

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

Waukesha

Aurora Cancer Care-Waukesha

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

Wausau

Marshfield Clinic-Wausau Center

Rezwan Islam
Ph: 715-393-1400

Rezwan Islam
Principal Investigator

Wauwatosa

Aurora Cancer Care-Milwaukee West

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

West Allis

Aurora West Allis Medical Center

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

Weston

Marshfield Clinic - Weston Center

Rezwan Islam
Ph: 715-393-1400

Rezwan Islam
Principal Investigator

Wisconsin Rapids

Marshfield Clinic - Wisconsin Rapids Center

Rezwan Islam
Ph: 715-393-1400

Rezwan Islam
Principal Investigator

Wyoming
Cheyenne

Cheyenne Regional Medical Center-West

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Cody

Big Horn Basin Cancer Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Billings Clinic-Cody

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Sheridan

Welch Cancer Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01573442

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.