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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

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 ApplemanPrincipal 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
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
  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
  Kewanee
 Illinois CancerCare - Kewanee Clinic
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  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
  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
  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
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
 Ajjai S Alva Ph: 800-865-1125
 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
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
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
  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
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
  Pittsburgh
 UPMC Cancer Centers
 Leonard Joseph Appleman Ph: 412-647-8073
 Leonard Joseph Appleman Ph: 412-648-6507
  Email: applemanlj@upmc.edu
  Pottstown
 Pottstown Memorial Regional Cancer Center
 Wei Song Ph: 610-327-7544
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 Identifer NCT01575548
ClinicalTrials.gov processed this data on April 26, 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.

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