Paclitaxel and Carboplatin or Bleomycin Sulfate, Etoposide Phosphate, and Cisplatin in Treating Patients with Advanced or Recurrent Sex Cord-Ovarian Stromal Tumors

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IIBiomarker/Laboratory analysis, Treatment18 and overGOG-0264
NCI-2011-02000, CDR0000662814, NCT01042522

Trial Description

Summary

This randomized phase II trial studies paclitaxel and carboplatin to see how well they work compared with bleomycin sulfate, etoposide phosphate, and cisplatin in treating patients with sex cord-ovarian stromal tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or has returned (recurrent). Drugs used in chemotherapy 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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating sex cord-ovarian stromal tumors.

Further Study Information

PRIMARY OBJECTIVES:

I. To assess the activity of paclitaxel and carboplatin with respect to progression free survival (using bleomycin, etoposide, and cisplatin [BEP] as a reference) for newly diagnosed advanced or recurrent chemonaive ovarian sex cord-stromal tumors.

SECONDARY OBJECTIVES:

I. To estimate the toxicity of paclitaxel and carboplatin, and bleomycin, etoposide, and cisplatin in this patient population.

II. To estimate overall survival for paclitaxel and carboplatin relative to that of BEP.

III. To evaluate response rate in the subset of patients with measurable disease.

TERTIARY OBJECTIVES:

I. To collect fixed and/or frozen tumor tissue for future translational research studies.

II. To explore the utility of inhibin A and inhibin B as prognostic and predictive biomarkers for ovarian sex cord-stromal tumors and to examine changes in these markers with treatment.

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

ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive bleomycin sulfate IV on day 1 and etoposide phosphate* IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

NOTE: *Patients who have received prior radiotherapy receive etoposide phosphate on days 1-4.

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

Eligibility Criteria

Inclusion Criteria:

Recovery from effects of recent surgery, radiotherapy, or chemotherapy

Patients must be entered within 8 weeks after surgery performed for either 1) initial diagnosis, staging, and/or cytoreduction, or 2) (if done) management of recurrent disease in a chemonaive patient

Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration; continuation of hormone replacement therapy is permitted

Patients with a history of hypersensitivity reactions to prior chemotherapy administered for previous cancer diagnoses are eligible to participate in the study, unless the hypersensitivity reaction consisted of anaphylaxis not amenable to desensitization

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

No signs of clinically significant hearing loss

Creatinine no greater than the institutional upper limits of normal

Patients in the measureable disease cohort must have at least one “target lesion” to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as “non-target” lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy

Alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE grade 1)

Platelet greater than or equal to 100,000/mcl

Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, equivalent to Common Terminology Criteria for Adverse Events (CTCAE) grade 1

Patients of childbearing potential must have a negative serum pregnancy test and must agree to practice an effective means of birth control

Patients must have a Gynecologic Oncology Group (GOG) performance grade of 0, 1, or 2

Patients must have newly diagnosed, stage IIA – IV disease and must be entered within eight weeks from surgery; they may have either measurable residual disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria, or they may have no measurable residual disease; OR, they must have biopsy-proven recurrent disease of any stage and have never received cytotoxic chemotherapy

Patients with histologically confirmed ovarian stromal tumor [granulosa cell tumor, ganulosa cell-theca cell tumor, Sertoli-Leydig cell tumor (androblastoma), steroid (lipid) cell tumor, gynandroblastoma, unclassified sex cord-stromal tumor, sex cord tumor with annular tubules]

Patients must have pulmonary function sufficient to receive bleomycin, with normal lung expansion, absence of crackles on auscultation, and normal carbon monoxide diffusion (DLCO), defined as greater than 80% predicted

Neuropathy (sensory and motor) less than or equal to CTCAE grade 1

Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) less than or equal to 3.0 x ULN (CTCAE grade 1)

Bilirubin less than or equal to 1.5 x upper limit of normal (ULN) (CTCAE grade 1)

Exclusion Criteria:

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 who have received any prior cytotoxic chemotherapy or biologics for sex cord-stromal tumors (SCSTs)

Patients with apparent stage I disease who have not undergone a staging procedure

Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study; the investigator can consult the study chair or study co-chairs for uncertainty in this regard

Woman who are pregnant or breastfeeding

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

NRG Oncology

  • National Cancer Institute
Jubilee Brown, Principal Investigator

Trial Sites

U.S.A.

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
Augusta

Georgia Regents University Medical Center

Sharad Anant Ghamande
Ph: 706-721-1663
Email: cancer@georgiahealth.edu

Sharad Anant Ghamande
Principal Investigator

Macon

Central Georgia Gynecologic Oncology

Gary Lee Eddy
Ph: 478-633-6090

Gary Lee Eddy
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

Memorial University Medical Center

James Joseph Burke
Ph: 912-350-8568

James Joseph Burke
Principal Investigator

Illinois
Bloomington

Illinois CancerCare-Bloomington

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Saint Joseph Medical Center

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

James Lloyd Wade
Principal Investigator

Canton

Illinois CancerCare-Canton

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Carbondale

Memorial Hospital of Carbondale

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

James Lloyd Wade
Principal Investigator

Carthage

Illinois CancerCare-Carthage

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Centralia

Centralia Oncology Clinic

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

James Lloyd Wade
Principal Investigator

Chicago

University of Chicago Comprehensive Cancer Center

Meaghan Elizabeth Tenney
Ph: 773-834-7424

Meaghan Elizabeth Tenney
Principal Investigator

Decatur

Cancer Care Center of Decatur

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

James Lloyd Wade
Principal Investigator

Decatur Memorial Hospital

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

James Lloyd Wade
Principal Investigator

Effingham

Crossroads Cancer Center

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

James Lloyd Wade
Principal Investigator

Eureka

Illinois CancerCare-Eureka

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Galesburg

Illinois CancerCare Galesburg

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Western Illinois Cancer Treatment Center

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

James Lloyd Wade
Principal Investigator

Hinsdale

Sudarshan K Sharma MD Limted-Gynecologic Oncology

Sudarshan K. Sharma
Ph: 630-856-6757

Sudarshan K. Sharma
Principal Investigator

Kewanee

Illinois CancerCare-Kewanee Clinic

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Macomb

Illinois CancerCare-Macomb

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Mount Vernon

Good Samaritan Regional Health Center

Jay W. Carlson
Ph: 800-821-7532

Jay W. Carlson
Principal Investigator

New Lennox

UC Comprehensive Cancer Center at Silver Cross

Seiko Diane Yamada
Ph: 773-834-7424

Seiko Diane Yamada
Principal Investigator

Ottawa

Illinois CancerCare-Ottawa Clinic

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Radiation Oncology of Northern Illinois

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

James Lloyd Wade
Principal Investigator

Pekin

Illinois CancerCare-Pekin

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Pekin Cancer Treatment Center

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

James Lloyd Wade
Principal Investigator

Peoria

Illinois CancerCare-Peoria

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Methodist Medical Center of Illinois

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

OSF Saint Francis Medical Center

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

James Lloyd Wade
Principal Investigator

Peru

Illinois CancerCare-Peru

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Valley Radiation Oncology

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

James Lloyd Wade
Principal Investigator

Princeton

Illinois CancerCare-Princeton

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Springfield

Central Illinois Hematology Oncology Center

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

James Lloyd Wade
Principal Investigator

Memorial Medical Center

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

James Lloyd Wade
Principal Investigator

Southern Illinois University School of Medicine

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

James Lloyd Wade
Principal Investigator

Springfield Clinic

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

James Lloyd Wade
Principal Investigator

Swansea

Cancer Care Specialists of Illinois-Swansea

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

James Lloyd Wade
Principal Investigator

Indiana
Indianapolis

Saint Vincent Oncology Center

Gregory P. Sutton
Ph: 574-237-1328

Gregory P. Sutton
Principal Investigator

Iowa
Iowa City

University of Iowa/Holden Comprehensive Cancer Center

David Paul Bender
Ph: 800-237-1225

David Paul Bender
Principal Investigator

Maryland
Baltimore

Johns Hopkins University/Sidney Kimmel Cancer Center

Deborah Kay Armstrong
Ph: 410-955-8804
Email: jhcccro@jhmi.edu

Deborah Kay Armstrong
Principal Investigator

Sinai Hospital of Baltimore

Abbie L. Fields
Ph: 410-601-6120
Email: pridgely@lifebridgehealth.org

Abbie L. Fields
Principal Investigator

Michigan
Detroit

Henry Ford Hospital

Thomas E. Buekers
Ph: 313-916-1784

Thomas E. Buekers
Principal Investigator

Escanaba

Green Bay Oncology - Escanaba

Jonathan Edward Tammela
Ph: 920-433-8889

Jonathan Edward Tammela
Principal Investigator

Iron Mountain

Green Bay Oncology - Iron Mountain

Jonathan Edward Tammela
Ph: 920-433-8889

Jonathan Edward Tammela
Principal Investigator

Mississippi
Jackson

University of Mississippi Medical Center

James Tate Thigpen
Ph: 601-815-6700

James Tate Thigpen
Principal Investigator

Missouri
Bolivar

Central Care Cancer Center-Carrie J Babb Cancer Center

Jay W. Carlson
Ph: 800-821-7532

Jay W. Carlson
Principal Investigator

Bonne Terre

Parkland Health Center-Bonne Terre

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

James Lloyd Wade
Principal Investigator

Branson

CoxHealth Cancer Center

Jay W. Carlson
Ph: 800-821-7532

Jay W. Carlson
Principal Investigator

Cape Girardeau

Saint Francis Medical Center

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

James Lloyd Wade
Principal Investigator

Southeast Cancer Center

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

James Lloyd Wade
Principal Investigator

Jefferson City

Capital Region Medical Center-Goldschmidt Cancer Center

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

James Lloyd Wade
Principal Investigator

Joplin

Freeman Health System

Jay W. Carlson
Ph: 800-821-7532

Jay W. Carlson
Principal Investigator

Mercy Hospital-Joplin

Jay W. Carlson
Ph: 800-821-7532

Jay W. Carlson
Principal Investigator

Rolla

Phelps County Regional Medical Center

Jay W. Carlson
Ph: 800-821-7532

Jay W. Carlson
Principal Investigator

Saint John's Clinic-Rolla-Cancer and Hematology

Jay W. Carlson
Ph: 800-821-7532

Jay W. Carlson
Principal Investigator

Saint Louis

Mercy Hospital Saint Louis

Jay W. Carlson
Ph: 800-821-7532

Jay W. Carlson
Principal Investigator

Missouri Baptist Medical Center

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

James Lloyd Wade
Principal Investigator

Saint Louis Cancer and Breast Institute-South City

Jay W. Carlson
Ph: 800-821-7532

Jay W. Carlson
Principal Investigator

Sainte Genevieve

Sainte Genevieve County Memorial Hospital

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

James Lloyd Wade
Principal Investigator

Springfield

CoxHealth South Hospital

Jay W. Carlson
Ph: 800-821-7532

Jay W. Carlson
Principal Investigator

Mercy Hospital Springfield

Jay W. Carlson
Ph: 800-821-7532

Jay W. Carlson
Principal Investigator

Sunset Hills

Missouri Baptist Outpatient Center-Sunset Hills

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

James Lloyd Wade
Principal Investigator

Nebraska
Omaha

Nebraska Methodist Hospital

Peter Craig Morris
Ph: 402-354-7939
Email: kathryn.bartz@nmhs.org

Peter Craig Morris
Principal Investigator

Nevada
Las Vegas

Women's Cancer Center of Nevada

Nicola M. Spirtos
Ph: 702-851-4672

Nicola M. Spirtos
Principal Investigator

New Jersey
Basking Ridge

Memorial Sloan Kettering Cancer Center at Basking Ridge

Mario Mendes Leitao
Ph: 212-639-7202

Mario Mendes Leitao
Principal Investigator

New Mexico
Albuquerque

University of New Mexico

Jubilee Brown
Ph: 713-792-3245
Email: jbbrown@mdanderson.org

Jubilee Brown
Principal Investigator

New York
Commack

Memorial Sloan Kettering Cancer Center Commack

Mario Mendes Leitao
Ph: 212-639-7202

Mario Mendes Leitao
Principal Investigator

New York

Memorial Sloan-Kettering Cancer Center

Mario Mendes Leitao
Ph: 212-639-7202

Mario Mendes Leitao
Principal Investigator

Rockville Centre

Memorial Sloan-Kettering Cancer Center Rockville Centre

Mario Mendes Leitao
Ph: 212-639-7202

Mario Mendes Leitao
Principal Investigator

Sleepy Hollow

Memorial Sloan-Kettering Cancer Center Sleepy Hollow

Mario Mendes Leitao
Ph: 212-639-7202

Mario Mendes Leitao
Principal Investigator

West Harrison

Memorial Sloan-Kettering Cancer Center West Harrison

Mario Mendes Leitao
Ph: 212-639-7202

Mario Mendes Leitao
Principal Investigator

North Carolina
Chapel Hill

University of North Carolina at Chapel Hill

Linda Van Le
Ph: 877-668-0683
Email: cancerclinicaltrials@med.unc.edu

Linda Van Le
Principal Investigator

Durham

Duke University Medical Center

Angeles Alvarez Secord
Ph: 888-275-3853

Angeles Alvarez Secord
Principal Investigator

Winston-Salem

Wake Forest University Health Sciences

Samuel Smith Lentz
Ph: 336-713-6771

Samuel Smith Lentz
Principal Investigator

Ohio
Belpre

Strecker Cancer Center-Belpre

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Chillicothe

Adena Regional Medical Center

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Cleveland

Case Western Reserve University

Steven E. Waggoner
Ph: 800-641-2422

Steven E. Waggoner
Principal Investigator

Cleveland Clinic Cancer Center/Fairview Hospital

Steven E. Waggoner
Ph: 800-641-2422

Steven E. Waggoner
Principal Investigator

Cleveland Clinic Foundation

Steven E. Waggoner
Ph: 800-641-2422

Steven E. Waggoner
Principal Investigator

Columbus

Columbus Oncology and Hematology Associates Inc

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Doctors Hospital

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Grant Medical Center

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Mount Carmel Health Center West

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Ohio State University Comprehensive Cancer Center

Jubilee Brown

Jubilee Brown
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: 614-566-3275

John Philip Kuebler
Principal Investigator

Delaware

Delaware Health Center-Grady Cancer Center

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Delaware Radiation Oncology

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Grady Memorial Hospital

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Lancaster

Fairfield Medical Center

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Marietta

Marietta Memorial Hospital

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Mayfield Heights

Hillcrest Hospital Cancer Center

Steven E. Waggoner
Ph: 800-641-2422

Steven E. Waggoner
Principal Investigator

Mentor

Lake University Ireland Cancer Center

Steven E. Waggoner
Ph: 800-641-2422

Steven E. Waggoner
Principal Investigator

Mount Vernon

Knox Community Hospital

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Newark

Licking Memorial Hospital

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Newark Radiation Oncology

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Portsmouth

Southern Ohio Medical Center

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Springfield

Springfield Regional 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: 614-566-3275

John Philip Kuebler
Principal Investigator

Zanesville

Genesis HealthCare System

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: 405-271-4272
Email: julie-traylor@ouhsc.edu

Robert S. Mannel
Principal Investigator

Tulsa

Tulsa Cancer Institute

Robert S. Mannel
Ph: 405-271-4272
Email: julie-traylor@ouhsc.edu

Robert S. Mannel
Principal Investigator

Pennsylvania
Abington

Abington Memorial Hospital

Parviz Hanjani
Ph: 215-481-2402

Parviz Hanjani
Principal Investigator

Allentown

Lehigh Valley Hospital-Cedar Crest

Alyson F. McIntosh
Ph: 610-402-2273

Alyson F. McIntosh
Principal Investigator

Danville

Geisinger Medical Center

Radhika P. Gogoi
Ph: 570-271-5251

Radhika P. Gogoi
Principal Investigator

Hazleton

Geisinger Medical Center-Cancer Center Hazleton

Radhika P. Gogoi
Ph: 570-271-5251

Radhika P. Gogoi
Principal Investigator

Lewisburg

Geisinger Medical Oncology at Evangelical Community Hospital

Radhika P. Gogoi
Ph: 570-271-5251

Radhika P. Gogoi
Principal Investigator

Lewistown

Lewistown Hospital

Radhika P. Gogoi
Ph: 570-271-5251

Radhika P. Gogoi
Principal Investigator

Philadelphia

Temple University Hospital

Enrique Hernandez
Ph: 215-728-2983

Enrique Hernandez
Principal Investigator

Pottsville

Geisinger Medical Oncology-Pottsville

Radhika P. Gogoi
Ph: 570-271-5251

Radhika P. Gogoi
Principal Investigator

State College

Geisinger Medical Group

Radhika P. Gogoi
Ph: 570-271-5251

Radhika P. Gogoi
Principal Investigator

Wilkes-Barre

Geisinger Wyoming Valley/Henry Cancer Center

Radhika P. Gogoi
Ph: 570-271-5251

Radhika P. Gogoi
Principal Investigator

Rhode Island
Providence

Women and Infants Hospital

Paul A. DiSilvestro
Ph: 401-274-1122

Paul A. DiSilvestro
Principal Investigator

South Dakota
Sioux Falls

Avera Cancer Institute

Luis A. Rojas-Espaillat
Ph: 800-657-4377
Email: Jan.Healy@avera.org

Luis A. Rojas-Espaillat
Principal Investigator

Sanford Cancer Center-Oncology Clinic

Maria Caroline Bell
Ph: 218-333-5000

Maria Caroline Bell
Principal Investigator

Sanford USD Medical Center - Sioux Falls

Maria Caroline Bell
Ph: 218-333-5000

Maria Caroline Bell
Principal Investigator

Texas
Dallas

Parkland Memorial Hospital

David Scott Miller
Ph: 214-648-7097

David Scott Miller
Principal Investigator

UT Southwestern/Simmons Cancer Center-Dallas

David Scott Miller
Ph: 214-648-7097

David Scott Miller
Principal Investigator

Houston

M D Anderson Cancer Center

Jubilee Brown
Ph: 713-792-3245

Jubilee Brown
Principal Investigator

Wisconsin
Green Bay

Aurora BayCare Medical Center

Ali Mahdavi
Ph: 414-649-5717

Ali Mahdavi
Principal Investigator

Green Bay Oncology at Saint Vincent Hospital

Jonathan Edward Tammela
Ph: 920-433-8889

Jonathan Edward Tammela
Principal Investigator

Green Bay Oncology Limited at Saint Mary's Hospital

Jonathan Edward Tammela
Ph: 920-433-8889

Jonathan Edward Tammela
Principal Investigator

Saint Mary's Hospital

Jonathan Edward Tammela
Ph: 920-433-8889

Jonathan Edward Tammela
Principal Investigator

Saint Vincent Hospital

Jonathan Edward Tammela
Ph: 920-433-8889

Jonathan Edward Tammela
Principal Investigator

Manitowoc

Holy Family Memorial Hospital

Jonathan Edward Tammela
Ph: 920-433-8889

Jonathan Edward Tammela
Principal Investigator

Marinette

Bay Area Medical Center

Jonathan Edward Tammela
Ph: 920-433-8889

Jonathan Edward Tammela
Principal Investigator

Milwaukee

Aurora Saint Luke's Medical Center

Ali Mahdavi
Ph: 414-649-5717

Ali Mahdavi
Principal Investigator

Oconto Falls

Green Bay Oncology - Oconto Falls

Jonathan Edward Tammela
Ph: 920-433-8889

Jonathan Edward Tammela
Principal Investigator

Sturgeon Bay

Green Bay Oncology - Sturgeon Bay

Jonathan Edward Tammela
Ph: 920-433-8889

Jonathan Edward Tammela
Principal Investigator

West Allis

Aurora West Allis Medical Center

Ali Mahdavi
Ph: 414-649-5717

Ali Mahdavi
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01042522

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.