Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer Who Have No Evidence of Disease After Surgery

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, Tissue collection/Repository, TreatmentActive18 and overNCINCI-2012-00723
CDR0000730383, ECOG-E2810, E2810, U10CA180820, U10CA021115, NCT01575548

Trial Description

Summary

This randomized phase III trial studies how well pazopanib hydrochloride works compared to placebo in treating patients with kidney cancer that has spread to other parts of the body who have no evidence of disease after surgery. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Further Study Information

PRIMARY OBJECTIVES:

I. To evaluate disease-free survival with pazopanib (pazopanib hydrochloride) as compared to placebo, defined as the time from randomization to the development of recurrent disease, second primary cancer (other than localized breast, localized prostate, or non-melanoma skin cancer) or death from any cause for patients with metastatic renal cell carcinoma (RCC) with no evidence of disease following metastasectomy.

SECONDARY OBJECTIVES:

I. To describe the overall survival of patients with advanced RCC randomly assigned to receive placebo or pazopanib for one year following metastasectomy to no evidence of disease (NED).

II. To describe treatment and (at recurrence) disease-related adverse events in the two treatment arms.

III. To analyze quality-adjusted time without symptoms of disease or treatment (Q-TWiST) for subjects in the two treatment arms.

IV. To characterize changes in patient-reported fatigue and (at recurrence) kidney cancer-related symptoms during and following treatment with pazopanib compared to placebo.

V. To explore the association between plasma trough levels of pazopanib and disease-free and overall survival.

VI. To prospectively bank preserved tissue from primary tumors and associated metastatic sites in patients with RCC.

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

ARM I: Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive placebo PO QD on days 1-28. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for the first two years, every 6 months for the next 3 years, and then annually up to 10 years.

Eligibility Criteria

Inclusion Criteria:

  • Patient must have pathologically confirmed renal cell carcinoma with a clear cell component; pure papillary and chromophobe histologies are excluded; there must be pathologic confirmation of metastatic disease in the resected metastasectomy specimen
  • Patient must have undergone nephrectomy or partial nephrectomy to remove primary renal cell carcinoma (at any time in the past)
  • Patient must have undergone surgical resection to remove one or more sites of metastatic disease, with successful removal of all known sites 2-12 weeks prior to randomization; any number of prior metastasectomies may have been performed in the past, so long as the most recent procedure was within the 12 weeks of registration; the most recent procedure may be nephrectomy for a renal primary tumor
  • Patients with synchronous disease at initial diagnosis must have metastatic (M1) disease (American Joint Committee on Cancer [AJCC] 7th edition T1-4N0-1M1)
  • Positive surgical margins are permitted if the surgeon confirms complete resection of gross metastatic disease, and post-operative scans are negative
  • Patients presenting with metachronous disease may have distant metastases, regional lymph node or renal bed recurrence; recurrences at a partial nephrectomy resection site are not eligible if it is the only site of disease
  • Patients presenting with tumors within the kidneys (multiple synchronous or single/multiple metachronous) are not eligible if there are no extrarenal sites of disease (i.e. potential multifocal primary disease)
  • Patient must have no evidence of disease on post-operative imaging:
  • A computed tomography (CT) of the chest must be obtained within 4 weeks prior to randomization with or without contrast
  • A CT of the abdomen/pelvis must be obtained within 4 weeks prior to randomization with intravenous (IV) contrast (oral contrast may be added at the radiologist's discretion); an magnetic resonance imaging (MRI) of the abdomen/pelvis with gadolinium may be substituted for the CT if the CT with IV contrast is contra-indicated
  • An MRI of the brain with and without gadolinium must be done within 8 weeks prior to randomization; a CT of the brain with and without IV contrast is permitted if MRI is contra-indicated (i.e., pacemaker)
  • Patient must not have received any prior or concurrent systemic therapy for RCC; adjuvant placebo administration is permitted
  • Patient must have no active peptic ulcer disease
  • Patient must have no active inflammatory bowel disease
  • Patient must have no New York Heart Association (NYHA) class II or greater congestive heart failure
  • Patient must have no prior history or current clinically apparent central nervous system metastases
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the time of randomization
  • Absolute granulocyte count > 1,500/mcL
  • Platelets > 100,000/mcL
  • Total bilirubin < 1.5 x institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 x upper limit of normal (ULN)
  • Calculated creatinine clearance (CrCl) > 30 mL/min
  • Subjects must have a urine protein/creatinine (UPC) ratio < 1; if UPC >= 1, then a 24-hour urine total protein must be obtained; subjects must have a 24-hour urine protein value < 1 g to be eligible; use of urine dipstick for renal function assessment is not acceptable
  • Women must not be pregnant or breast-feeding
  • All females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study; should a woman become pregnant while participating in this study, she should inform her treating physician immediately; if a man impregnates a woman while participating in this study, he should inform his treating physician immediately
  • Patient must be able to swallow pills and have no significant impairment in gastrointestinal absorption including history of gastric bypass surgery
  • Patient must have no history of allergic reactions attributed to compounds of similar chemical or biologic composition to pazopanib
  • Patient must have no uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patient must have a corrected QT (QTc) interval on electrocardiogram (ECG) =< 0.48 seconds by Bazett's calculation (=< Common Terminology Criteria for Adverse Events [CTCAE] version [v.]4 grade 2) prior to randomization
  • Patient must have a systolic blood pressure =< 140 mmHg and diastolic blood pressure must be =< 90 mmHg, measured within 4 weeks prior to randomization; initiation or adjustment of anti-hypertensives prior to starting study treatment is allowed
  • Patient must not have serious or non-healing wound, ulcer, or bone fracture at the time of randomization
  • Patient must have no history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to randomization
  • Patient must have no history of cerebrovascular accident (CVA) within 6 months of randomization
  • Patient must have no history of myocardial infarction, hospital admission for unstable angina, cardiac angioplasty or stenting within 6 months of randomization
  • Patient must have no history of venous thrombosis within 12 weeks of randomization
  • Patient cannot be taking strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors such as:
  • Antibiotics: clarithromycin, telithromycin, troleandomycin
  • Human immunodeficiency virus (HIV) antiviral protease inhibitors: ritonavir, indinavir, saquinavir, nelfinavir, amprenavir, lopinavir
  • Antifungals: itraconazole, ketoconazole, voriconazole, fluconazole
  • Antidepressants: nefazodone
  • Patient must not have history of hemoptysis in excess of 2.5 mL (1/2 teaspoon) within 8 weeks prior to randomization
  • Patient must not be taking drugs known to prolong the QTc interval; such drugs should be discontinued at least 5 half-lives prior to randomization
  • Patients must not have any history of other cancer within 3 years from time of randomization with the exception of basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or resected non-invasive (Ta) urothelial carcinoma

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

    Leonard Appleman, Principal Investigator

    Trial Sites

    U.S.A.

    Alaska
    Fairbanks

    Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital

    John A Keech
    Ph: 907-458-5380

    California
    Duarte

    City of Hope Comprehensive Cancer Center

    Sumanta K Pal
    Ph: 800-826-4673
    Email: becomingapatient@coh.org

    La Jolla

    Rebecca and John Moores UCSD Cancer Center

    Frederick E Millard
    Ph: 858-822-5354
    Email: cancercto@ucsd.edu

    Los Angeles

    USC/Norris Comprehensive Cancer Center and Hospital

    David I. Quinn
    Ph: 323-865-0451

    David I. Quinn
    Ph: 323-865-0451

    Connecticut
    Hartford

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

    Philip J. Stella
    Ph: 734-712-4673

    District of Columbia
    Washington

    Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

    Nancy Ann Dawson
    Ph: 202-444-0381

    Georgia
    Columbus

    John B. Amos Cancer Center

    Andrew W. Pippas
    Ph: 706-660-6404

    Gainesville

    Northeast Georgia Medical Center

    Richard J. LoCicero
    Ph: 770-219-8800
    Email: cancerpatient.navigator@nghs.com

    Savannah

    Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler

    Grant C Lewis
    Ph: 912-350-8568

    Idaho
    Boise

    Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

    Philip J. Stella
    Ph: 734-712-4673

    Coeur D'Alene

    Kootenai Medical Center

    Benjamin Thomas Marchello
    Ph: 800-648-6274

    Lewiston

    St. Joseph Regional Medical Center

    Yoshio Inoue
    Ph: 253-403-2394

    Post Falls

    Kootenai Cancer Center - Post Falls

    Benjamin Thomas Marchello
    Ph: 800-648-6274

    Sandpoint

    Kootenai Cancer

    Benjamin Thomas Marchello
    Ph: 800-648-6274

    Illinois
    Aurora

    Rush-Copley Cancer Care Center

    Vamsi K Vasireddy
    Ph: 800-446-5532

    Bloomington

    Illinois CancerCare - Bloomington

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

    St. Joseph Medical Center

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

    Canton

    Illinois CancerCare - Canton

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

    Carbondale

    Memorial Hospital of Carbondale

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

    Carthage

    Illinois CancerCare - Carthage

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

    Centralia

    Centralia Oncology Clinic

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

    Chicago

    Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Timothy M. Kuzel
    Ph: 312-695-1301
    Email: cancer@northwestern.edu

    Danville

    Carle on Vermilion

    Vamsi K Vasireddy
    Ph: 800-446-5532

    Decatur

    Cancer Care Center of Decatur

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

    Decatur Memorial Hospital Cancer Care Institute

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

    Effingham

    Carle Physician Group-Effingham

    Vamsi K Vasireddy
    Ph: 800-446-5532

    Crossroads Cancer Center

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

    Eureka

    Illinois CancerCare - Eureka

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

    Galesburg

    Galesburg Clinic, PC

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

    InterCommunity Cancer Center of Western Illinois

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

    Medical and Surgical Specialists, LLC

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

    Highland Park

    Hematology Oncology Associates of Illinois-Highland Park

    Timothy M. Kuzel
    Ph: 312-695-1301
    Email: cancer@northwestern.edu

    Kankakee

    Provena St. Mary's Regional Cancer Center - Kankakee

    Timothy M. Kuzel
    Ph: 312-695-1301
    Email: cancer@northwestern.edu

    Kewanee

    Illinois CancerCare - Kewanee Clinic

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

    Libertyville

    North Shore Oncology and Hematology Associates, Limited - Libertyville

    Timothy M. Kuzel
    Ph: 312-695-1301
    Email: cancer@northwestern.edu

    Macomb

    Illinois CancerCare - Macomb

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

    Mattoon

    Carle Physician Group-Mattoon/Charleston

    Vamsi K Vasireddy
    Ph: 800-446-5532

    Maywood

    Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Joseph I. Clark
    Ph: 708-226-4357

    Niles

    Cancer Care and Hematology Specialists of Chicagoland - Niles

    Timothy M. Kuzel
    Ph: 312-695-1301
    Email: cancer@northwestern.edu

    Ottawa

    Illinois CancerCare - Ottawa

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

    Radiation Oncology of Northern Illinois

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

    Pekin

    Cancer Treatment Center at Pekin Hospital

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

    Illinois CancerCare - Pekin

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

    Peoria

    Illinois CancerCare - Peoria

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

    Methodist Medical Center of Illinois

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

    OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC

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

    OSF St. Francis Medical Center

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

    Peru

    Illinois CancerCare - Princeton

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

    Valley Cancer Center

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

    Princeton

    Illinois CancerCare - Princeton

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

    Skokie

    Hematology Oncology Associates - Skokie

    Timothy M. Kuzel
    Ph: 312-695-1301
    Email: cancer@northwestern.edu

    Springfield

    Central Illinois Hematology Oncology Center

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

    Regional Cancer Center at Memorial Medical Center

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

    Simmons Cooper Cancer Institute

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

    Springfield Clinic - Main Campus

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

    Urbana

    Carle Cancer Center at Carle Foundation Hospital

    Vamsi K Vasireddy
    Ph: 800-446-5532

    Vamsi K Vasireddy
    Ph: 800-446-5532

    Warrenville

    Central Dupage Cancer Center

    Robert M Eisner
    Ph: 630-352-5300

    Yorkville

    Rush-Copley Healthcare Center

    Vamsi K Vasireddy
    Ph: 800-446-5532

    Indiana
    Indianapolis

    Indiana University Melvin and Bren Simon Cancer Center

    Theodore F. Logan
    Ph: 317-274-2552

    Michigan City

    Saint Anthony Memorial Health Centers

    Vamsi K Vasireddy
    Ph: 800-446-5532

    Woodland Cancer Care Center

    Vamsi K Vasireddy
    Ph: 800-446-5532

    Mishawaka

    Memorial Regional Cancer Center Day Road

    Thomas Joseph Reid
    Ph: 800-284-7370

    Richmond

    Reid Hospital & Health Care Services

    Howard M. Gross
    Ph: 937-775-1350

    South Bend

    Memorial Hospital of South Bend

    Thomas Joseph Reid
    Ph: 800-284-7370

    Iowa
    Iowa City

    Holden Comprehensive Cancer Center at University of Iowa

    Daniel A Vaena
    Ph: 800-237-1225

    Mason City

    Mercy Cancer Center at Mercy Medical Center - North Iowa

    Arvind Y Vemula
    Ph: 800-433-3883

    Kansas
    Topeka

    Cotton-O'Neil Cancer Center

    David E Einspahr
    Ph: 785-270-4963

    Kentucky
    Crestview Hills

    Oncology Hematology Care, Incorporated - Crestview Hills

    Howard M. Gross
    Ph: 937-775-1350

    Louisiana
    Metairie

    East Jefferson General Hospital

    Augusto C Ochoa
    Ph: 504-568-2428
    Email: emede1@lsuhsc.edu

    Robert Veith MD LLC

    Augusto C Ochoa
    Ph: 504-568-2428
    Email: emede1@lsuhsc.edu

    New Orleans

    Medical Center of Louisiana - New Orleans

    Augusto C Ochoa
    Ph: 504-568-2428
    Email: emede1@lsuhsc.edu

    Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans

    Augusto C Ochoa
    Ph: 504-568-2428
    Email: emede1@lsuhsc.edu

    Michigan
    Ann Arbor

    Saint Joseph Mercy Cancer Center

    Philip J. Stella
    Ph: 734-712-4673

    University of Michigan Comprehensive Cancer Center

    Leonard Joseph Appleman
    Ph: 412-647-8073
    Email: applemanlj@upmc.edu

    Battle Creek

    Battle Creek Health System Cancer Care Center

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

    Dearborn

    Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Philip J. Stella
    Ph: 734-712-4673

    Detroit

    Van Elslander Cancer Center at St. John Hospital and Medical Center

    Philip J. Stella
    Ph: 734-712-4673

    Flint

    Genesys Hurley Cancer Institute

    Philip J. Stella
    Ph: 734-712-4673

    Hurley Medical Center

    Philip J. Stella
    Ph: 734-712-4673

    Grand Rapids

    Butterworth Hospital at Spectrum Health

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

    Lacks Cancer Center at Saint Mary's Health Care

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

    Jackson

    Gayle M. Jacob Cancer Center at Allegiance Health

    Philip J. Stella
    Ph: 734-712-4673

    Kalamazoo

    West Michigan Cancer Center

    Sunil Nagpal
    Ph: 269-373-7458

    Lansing

    Sparrow Regional Cancer Center

    Philip J. Stella
    Ph: 734-712-4673

    Livonia

    St. Mary Mercy Hospital

    Philip J. Stella
    Ph: 734-712-4673

    Muskegon

    Mercy General Health Partners

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

    Niles

    Lakeland Hospital - Niles

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

    Pontiac

    St. Joseph Mercy Oakland

    Philip J. Stella
    Ph: 734-712-4673

    Port Huron

    Mercy Regional Cancer Center at Mercy Hospital

    Philip J. Stella
    Ph: 734-712-4673

    Reed City

    Spectrum Health Reed City Hospital

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

    Saginaw

    Seton Cancer Institute at Saint Mary's - Saginaw

    Philip J. Stella
    Ph: 734-712-4673

    Saint Joseph

    Lakeside Cancer Specialists, PLLC

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

    St. Joseph

    Lakeland Regional Cancer Care Center - St. Joseph

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

    Traverse City

    Munson Medical Center

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

    Warren

    St. John Macomb Hospital

    Philip J. Stella
    Ph: 734-712-4673

    Minnesota
    Rochester

    Mayo Clinic Cancer Center

    Brian A Costello
    Ph: 507-538-7623

    Mississippi
    Jackson

    University of Mississippi Cancer Clinic

    Louis V Puneky
    Ph: 601-815-6700

    Missouri
    Bonne Terre

    Parkland Health Center-Bonne Terre

    Alan Philip Lyss
    Ph: 800-392-0936

    Cape Girardeau

    Saint Francis Medical Center

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

    Southeast Cancer Center

    Alan Philip Lyss
    Ph: 800-392-0936

    Jefferson City

    Goldschmidt Cancer Center

    Alan Philip Lyss
    Ph: 800-392-0936

    Saint Louis

    CCOP - St. Louis-Cape Girardeau

    Bethany G. Sleckman
    Ph: 913-948-5588

    David C. Pratt Cancer Center at St. John's Mercy

    Bethany G. Sleckman
    Ph: 913-948-5588

    Mercy Clinic St. Louis Cancer and Breast Institute

    Bethany G. Sleckman
    Ph: 913-948-5588

    Missouri Baptist Cancer Center

    Alan Philip Lyss
    Ph: 800-392-0936

    Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

    Joel Picus
    Ph: 800-600-3606
    Email: info@siteman.wustl.edu

    Sainte Genevieve

    Sainte Genevieve County Memorial Hospital

    Alan Philip Lyss
    Ph: 800-392-0936

    Sullivan

    Missouri Baptist Sullivan Hospital

    Alan Philip Lyss
    Ph: 800-392-0936

    Sunset Hills

    Missouri Baptist Outpatient Center-Sunset Hills

    Alan Philip Lyss
    Ph: 800-392-0936

    Montana
    Billings

    Billings Clinic Cancer Center - 801 N 29th Street

    Benjamin Thomas Marchello
    Ph: 800-648-6274

    CCOP - Montana Cancer Consortium

    Benjamin Thomas Marchello
    Ph: 800-648-6274

    St. Vincent Healthcare Cancer Care Services

    Benjamin Thomas Marchello
    Ph: 800-648-6274

    Bozeman

    Bozeman Deaconess Cancer Center

    Benjamin Thomas Marchello
    Ph: 800-648-6274

    Butte

    St. James Healthcare Cancer Care

    Benjamin Thomas Marchello
    Ph: 800-648-6274

    Great Falls

    Benefis Sletten Cancer Institute

    Benjamin Thomas Marchello
    Ph: 800-648-6274

    Helena

    St. Peter's Hospital

    Benjamin Thomas Marchello
    Ph: 800-648-6274

    Kalispell

    Kalispell Regional Medical Center

    Benjamin Thomas Marchello
    Ph: 800-648-6274

    Missoula

    Community Medical Center

    Benjamin Thomas Marchello
    Ph: 800-648-6274

    Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Benjamin Thomas Marchello
    Ph: 800-648-6274

    Nebraska
    Omaha

    Methodist Estabrook Cancer Center

    Ralph Hauke
    Ph: 402-354-5144

    Nevada
    Henderson

    21st Century Oncology - Henderson

    John Allan Ellerton
    Ph: 702-384-0013

    Cancer and Blood Specialists-Henderson

    John Allan Ellerton
    Ph: 702-384-0013

    Comprehensive Cancer Centers of Nevada - Henderson

    John Allan Ellerton
    Ph: 702-384-0013

    Comprehensive Cancer Centers of Nevada-Southeast Henderson

    John Allan Ellerton
    Ph: 702-384-0013

    Las Vegas Cancer Center - Henderson

    John Allan Ellerton
    Ph: 702-384-0013

    Las Vegas

    21st Century Oncology - Fort Apache

    John Allan Ellerton
    Ph: 702-384-0013

    21st Century Oncology - Vegas Sunrise

    John Allan Ellerton
    Ph: 702-384-0013

    21st Century Oncology - Vegas Tenaya

    John Allan Ellerton
    Ph: 702-384-0013

    Cancer and Blood Specialists-Fort Apache

    John Allan Ellerton
    Ph: 702-384-0013

    Cancer and Blood Specialists-Shadow

    John Allan Ellerton
    Ph: 702-384-0013

    Cancer and Blood Specialists-Tenaya

    John Allan Ellerton
    Ph: 702-384-0013

    Cancer Institute of Nevada at Summerlin Hospital Medical Center

    John Allan Ellerton
    Ph: 702-384-0013

    John Allan Ellerton
    Ph: 702-384-0013

    Cancer Therapy and Integrative Medicine

    John Allan Ellerton
    Ph: 702-384-0013

    CCOP - Nevada Cancer Research Foundation

    John Allan Ellerton
    Ph: 702-384-0013

    Children's Specialty Center of Nevada

    John Allan Ellerton
    Ph: 702-384-0013

    Comprehensive Cancer Centers of Nevada - Central Valley

    John Allan Ellerton
    Ph: 702-384-0013

    Comprehensive Cancer Centers of Nevada - Northwest

    John Allan Ellerton
    Ph: 702-384-0013

    Comprehensive Cancer Centers of Nevada - Southwest

    John Allan Ellerton
    Ph: 702-384-0013

    HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills

    John Allan Ellerton
    Ph: 702-384-0013

    HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

    John Allan Ellerton
    Ph: 702-384-0013

    HealthCare Partners Medical Group Oncology/Hematology-San Martin

    John Allan Ellerton
    Ph: 702-384-0013

    HealthCare Partners Medical Group Oncology/Hematology-Tenaya

    John Allan Ellerton
    Ph: 702-384-0013

    Las Vegas Cancer Center-Medical Center

    John Allan Ellerton
    Ph: 702-384-0013

    Radiation Oncology Centers of Las Vegas - Downtown Location

    John Allan Ellerton
    Ph: 702-384-0013

    Radiation Oncology Centers of Las Vegas - Eastern Location

    John Allan Ellerton
    Ph: 702-384-0013

    New Jersey
    New Brunswick

    Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

    Eric A Singer
    Ph: 732-235-8675

    New York
    Bronx

    Albert Einstein Cancer Center at Albert Einstein College of Medicine

    Benjamin A Gartrell
    Ph: 718-904-2730
    Email: aecc@aecom.yu.edu

    Jack D. Weiler Hospital at Montefiore Medical Center - East Campus

    Benjamin A Gartrell
    Ph: 718-904-2730
    Email: aecc@aecom.yu.edu

    Montefiore Medical Center

    Benjamin A Gartrell
    Ph: 718-904-2730
    Email: aecc@aecom.yu.edu

    North Carolina
    Asheboro

    Randolph Hospital

    James M Granfortuna
    Ph: 336-832-0821

    Burlington

    Alamance Cancer Center at Alamance Regional Medical Center

    James M Granfortuna
    Ph: 336-832-0821

    Clinton

    Sampson Radiation Oncology

    James N. Atkins
    Ph: 919-580-0000

    Southeastern Medical Oncology Center-Clinton

    James N. Atkins
    Ph: 919-580-0000

    Goldsboro

    Southeastern Medical Oncology Center - Goldsboro

    James N. Atkins
    Ph: 919-580-0000

    Wayne Memorial Hospital, Incorporated

    James N. Atkins
    Ph: 919-580-0000

    Wayne Radiation Oncology

    James N. Atkins
    Ph: 919-580-0000

    Greensboro

    Moses Cone Regional Cancer Center at Wesley Long Community Hospital

    James M Granfortuna
    Ph: 336-832-0821

    Jacksonville

    Onslow Memorial Hospital

    James N. Atkins
    Ph: 919-580-0000

    Southeastern Medical Oncology Center-Jacksonville

    James N. Atkins
    Ph: 919-580-0000

    Kinston

    Kinston Medical Specialists

    Peter R. Watson
    Ph: 252-559-2200

    Mebane

    Cone Heath Cancer Center at Mebane

    James M Granfortuna
    Ph: 336-832-0821

    Reidsville

    Annie Penn Cancer Center

    James M Granfortuna
    Ph: 336-832-0821

    Wilson

    Southeastern Medical Oncology Center - Wilson

    James N. Atkins
    Ph: 919-580-0000

    Ohio
    Belpre

    Strecker Cancer Center-Belpre

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

    Centerville

    Miami Valley Hospital South

    Howard M. Gross
    Ph: 937-775-1350

    Chillicothe

    Adena Regional Medical Center

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

    Cincinnati

    Oncology Hematology Care Inc - Western Hills

    Howard M. Gross
    Ph: 937-775-1350

    Oncology Hematology Care, Incorporated - Anderson

    Howard M. Gross
    Ph: 937-775-1350

    Oncology Hematology Care, Incorporated - Blue Ash

    Howard M. Gross
    Ph: 937-775-1350

    Oncology Hematology Care, Incorporated - Kenwood

    Howard M. Gross
    Ph: 937-775-1350

    Oncology Hematology Care, Incorporated - Mt. Auburn/Taft Road

    Howard M. Gross
    Ph: 937-775-1350

    Columbus

    Columbus Oncology Associates, Incorporated

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

    Doctors Hospital at Ohio Health

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

    Grant Medical Center Cancer Care

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

    Mount Carmel Health - West Hospital

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

    Riverside Methodist Hospital Cancer Care

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

    Zangmeister Center

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

    Dayton

    David L. Rike Cancer Center at Miami Valley Hospital

    Howard M. Gross
    Ph: 937-775-1350

    Good Samaritan Hospital

    Howard M. Gross
    Ph: 937-775-1350

    Samaritan North Cancer Care Center

    Howard M. Gross
    Ph: 937-775-1350

    Delaware

    Delaware Health Center

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

    Delaware Radiation Oncology

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

    Grady Memorial Hospital

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

    Fairfield

    Oncology Hematology Care, Incorporated - Fairfield Healthplex

    Howard M. Gross
    Ph: 937-775-1350

    Findlay

    Blanchard Valley Regional Cancer Center

    Howard M. Gross
    Ph: 937-775-1350

    Franklin

    Atrium Medical Center

    Howard M. Gross
    Ph: 937-775-1350

    Greenville

    Wayne Hospital

    Howard M. Gross
    Ph: 937-775-1350

    Kettering

    Charles F. Kettering Memorial Hospital

    Howard M. Gross
    Ph: 937-775-1350

    Lancaster

    Fairfield Medical Center

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

    Marietta

    Strecker Cancer Center at Marietta Memorial Hospital

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

    Mount Vernon

    Knox Community Hospital

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

    Newark

    Licking Memorial Cancer Care Program at Licking Memorial Hospital

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

    Newark Radiation Oncology

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

    Portsmouth

    Southern Ohio Medical Center Cancer Center

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

    Springfield

    Community Hospital of Springfield and Clark County

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

    Steubenville

    UPMC Cancer Center at Terarama Cancer Center

    Leonard Joseph Appleman
    Ph: 412-647-8073

    Troy

    UVMC Cancer Care Center at Upper Valley Medical Center

    Howard M. Gross
    Ph: 937-775-1350

    Westerville

    Mount Carmel St. Ann's Cancer Center

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

    Zanesville

    Genesis - Good Samaritan Hospital

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

    Oklahoma
    Lawton

    Cancer Centers of Southwest Oklahoma, LLC - Lawton

    Nadim F. Nimeh
    Ph: 877-231-4440

    Oregon
    Portland

    Knight Cancer Institute at Oregon Health and Science University

    Christopher W. Ryan
    Ph: 503-494-1080
    Email: trials@ohsu.edu

    Pennsylvania
    Allentown

    Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

    Eliot Lawrence Friedman
    Ph: 610-402-2273

    Bethlehem

    Lehigh Valley Hospital - Muhlenberg

    Eliot Lawrence Friedman
    Ph: 610-402-2273

    Philadelphia

    Abramson Cancer Center of the University of Pennsylvania

    Naomi S. Balzer-Haas
    Ph: 800-474-9892

    Pittsburgh

    UPMC Cancer Centers

    Leonard Joseph Appleman
    Ph: 412-647-8073

    Pottstown

    Pottstown Memorial Regional Cancer Center

    Wei Song
    Ph: 610-327-7544

    South Carolina
    Greenville

    Bon Secours St. Francis Health System

    Robert D. Siegel
    Ph: 864-255-1713

    Saint Francis Cancer Center

    Robert D. Siegel
    Ph: 864-255-1713

    South Dakota
    Rapid City

    Rapid City Regional Hospital

    Joshua C Lukenbill
    Ph: 605-716-3982
    Email: research@rcrh.org

    Tennessee
    Bristol

    Blue Ridge Medical Specialists, PC

    Asheesh Shipstone
    Ph: 423-578-8538

    Wellmont-Bristol Regional Medical Center

    Asheesh Shipstone
    Ph: 423-578-8538

    Chattanooga

    Erlanger Cancer Center at Erlanger Hospital - Baroness

    Larry L. Schlabach
    Ph: 423-778-6947

    Kingsport

    Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center

    Asheesh Shipstone
    Ph: 423-578-8538

    Kingsport Hematology-Oncology Associates

    Asheesh Shipstone
    Ph: 423-578-8538

    Utah
    Salt Lake City

    Huntsman Cancer Institute at University of Utah

    Junfeng Wang
    Ph: 801-581-4477
    Email: clinical.trials@hci.utah.edu

    Virginia
    Midlothian

    Bon Secours Cancer Institute - Virginia Breast Center

    William J Irvin
    Ph: 804-594-4900

    Norton

    Southwest Virginia Regional Cancer Center at Wellmonth Health

    Asheesh Shipstone
    Ph: 423-578-8538

    Richmond

    Bon Secours Cancer Institute at St. Mary's Hospital

    William J Irvin
    Ph: 804-594-4900

    Washington
    Auburn

    Auburn Regional Center for Cancer Care

    John A Keech
    Ph: 907-458-5380

    Bainbridge Island

    Virginia Mason Bainbridge Island Medical Center

    John A Keech
    Ph: 907-458-5380

    Bellevue

    Overlake Cancer Center at Overlake Hospital Medical Center

    John A Keech
    Ph: 907-458-5380

    Centralia

    Providence Centralia Hospital

    Yoshio Inoue
    Ph: 253-403-2394

    Everett

    Providence Regional Cancer Partnership

    Yoshio Inoue
    Ph: 253-403-2394

    Federal Way

    Virginia Mason Federal Way Medical Center

    John A Keech
    Ph: 907-458-5380

    Gig Harbor

    MultiCare Gig Harbor Medical Park

    John A Keech
    Ph: 907-458-5380

    Tacoma/Valley Radiation Oncology Centers-Gig Harbor

    John A Keech
    Ph: 907-458-5380

    Kennewick

    Northwest Cancer Clinic

    John A Keech
    Ph: 907-458-5380

    Lacey

    Western Washington Oncology, Incorporated, PS at Western Washington Cancer Center

    Yoshio Inoue
    Ph: 253-403-2394

    Lynnwood

    Virginia Mason Lynnwood Medical Center

    John A Keech
    Ph: 907-458-5380

    Poulsbo

    Peninsula Cancer Center

    John A Keech
    Ph: 907-458-5380

    Puyallup

    Good Samaritan Cancer Center

    John A Keech
    Ph: 907-458-5380

    Takoma/Valley Radiation Oncology Center at Good Samaritan

    John A Keech
    Ph: 907-458-5380

    Seattle

    Virginia Mason Medical Center

    John A Keech
    Ph: 907-458-5380

    Tacoma

    MultiCare Regional Cancer Center at Tacoma General Hospital

    John A Keech
    Ph: 907-458-5380

    Northwest Medical Specialties, PLLC - Tacoma

    Yoshio Inoue
    Ph: 253-403-2394

    Tacoma/Valley Radiation Oncology Center - St. Joseph

    John A Keech
    Ph: 907-458-5380

    Tacoma/Valley Radiation Oncology Centers-Jackson Hall

    John A Keech
    Ph: 907-458-5380

    West Virginia
    Charleston

    West Virginia University Medical School - Charleston

    Steven J. Jubelirer
    Ph: 304-344-3457

    Princeton

    Princeton Community Hospital

    Rowena Gonzales-Chambers
    Ph: 304-487-7000

    Wisconsin
    Burlington

    Aurora Cancer Care-Burlington

    Rubina Qamar
    Ph: 888-709-2080

    Chippewa Falls

    Marshfield Clinic - Chippewa Center

    Seth Olusegun Fagbemi
    Ph: 715-389-4457

    Eau Claire

    Center for Cancer Treatment & Prevention at Sacred Heart Hospital

    Seth Olusegun Fagbemi
    Ph: 715-389-4457

    Marshfield Clinic Cancer Care at Regional Cancer Center

    Seth Olusegun Fagbemi
    Ph: 715-389-4457

    Elkhorn

    Vince Lombardi Cancer Center at Aurora Lakeland Medical Center - Elkhorn

    Rubina Qamar
    Ph: 888-709-2080

    Fond Du Lac

    Aurora Health Center-Fond du Lac

    Rubina Qamar
    Ph: 888-709-2080

    Grafton

    Aurora Cancer Care-Grafton

    Rubina Qamar
    Ph: 888-709-2080

    Green Bay

    Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center

    Rubina Qamar
    Ph: 888-709-2080

    Kenosha

    Oncology Alliance - Kenosha South

    Rubina Qamar
    Ph: 888-709-2080

    La Crosse

    Gundersen Lutheran Center for Cancer and Blood

    Kurt Oettel
    Ph: 608-775-2385
    Email: cancerctr@gundluth.org

    Ladysmith

    Marshfield Clinic - Ladysmith Center

    Seth Olusegun Fagbemi
    Ph: 715-389-4457

    Marinette

    Vince Lombardi Cancer Clinic - Marinette

    Rubina Qamar
    Ph: 888-709-2080

    Marshfield

    Marshfield Clinic - Marshfield Center

    Seth Olusegun Fagbemi
    Ph: 715-389-4457

    Saint Joseph's Hospital

    Seth Olusegun Fagbemi
    Ph: 715-389-4457

    Menomonee Falls

    Aurora Advanced Healthcare Inc-Menomonee Falls

    Rubina Qamar
    Ph: 888-709-2080

    Milwaukee

    Aurora Cancer Care-Milwaukee

    Rubina Qamar
    Ph: 888-709-2080

    Aurora Sinai Medical Center

    Rubina Qamar
    Ph: 888-709-2080

    Froedtert Hospital and Medical College of Wisconsin

    Kathryn A Bylow
    Ph: 414-805-4380

    Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

    Rubina Qamar
    Ph: 888-709-2080

    Wheaton Franciscan Cancer Care - St. Joseph

    Jonathan S. Treisman
    Ph: 414-427-2360

    Minocqua

    Marshfield Clinic - Lakeland Center

    Seth Olusegun Fagbemi
    Ph: 715-389-4457

    Oshkosh

    Vince Lombardi Cancer Clinic - Oshkosh

    Rubina Qamar
    Ph: 888-709-2080

    Racine

    Aurora Health Center - Racine

    Rubina Qamar
    Ph: 888-709-2080

    Rhinelander

    Ministry Medical Group at Saint Mary's Hospital

    Seth Olusegun Fagbemi
    Ph: 715-389-4457

    Seth Olusegun Fagbemi
    Ph: 715-389-4457

    Rice Lake

    Marshfield Clinic - Indianhead Center

    Seth Olusegun Fagbemi
    Ph: 715-389-4457

    Seth Olusegun Fagbemi
    Ph: 715-389-4457

    Sheboygan

    Vince Lombardi Cancer Clinic - Sheboygan

    Rubina Qamar
    Ph: 888-709-2080

    Stevens Point

    Marshfield Clinic at Saint Michael's Hospital

    Seth Olusegun Fagbemi
    Ph: 715-389-4457

    Saint Michael's Hospital Cancer Center

    Seth Olusegun Fagbemi
    Ph: 715-389-4457

    Summit

    Aurora Medical Center

    Rubina Qamar
    Ph: 888-709-2080

    Two Rivers

    Vince Lombardi Cancer Clinic - Two Rivers

    Rubina Qamar
    Ph: 888-709-2080

    Waukesha

    Aurora Cancer Care-Waukesha

    Rubina Qamar
    Ph: 888-709-2080

    Wausau

    Marshfield Clinic - Wausau Center

    Seth Olusegun Fagbemi
    Ph: 715-389-4457

    Wauwatosa

    Oncology Alliance, SC - Milwaukee - West

    Rubina Qamar
    Ph: 888-709-2080

    West Allis

    Aurora Women's Pavilion of West Allis Memorial Hospital

    Rubina Qamar
    Ph: 888-709-2080

    Weston

    Diagnostic and Treatment Center

    Seth Olusegun Fagbemi
    Ph: 715-389-4457

    Marshfield Clinic - Weston Center

    Seth Olusegun Fagbemi
    Ph: 715-389-4457

    Ministry Saint Clare's Hospital

    Seth Olusegun Fagbemi
    Ph: 715-389-4457

    Wisconsin Rapids

    Marshfield Clinic - Wisconsin Rapids Center

    Seth Olusegun Fagbemi
    Ph: 715-389-4457

    Wyoming
    Cody

    Big Horn Basin Cancer Center

    Benjamin Thomas Marchello
    Ph: 800-648-6274

    Billings Clinic-Cody

    Benjamin Thomas Marchello
    Ph: 800-648-6274

    Sheridan

    Welch Cancer Center at Sheridan Memorial Hospital

    Benjamin Thomas Marchello
    Ph: 800-648-6274

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT01575548
    ClinicalTrials.gov processed this data on May 21, 2015

    Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.