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Clinical Trials (PDQ®)

Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive18 and overNCI, OtherCDR0000526353
CALGB-90203, NCT00430183

Trial Description

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin and leuprolide, may stop the adrenal glands from making androgens. Giving docetaxel and leuprolide or goserelin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether giving docetaxel and leuprolide or goserelin before surgery is more effective than surgery alone in treating patients with prostate cancer.

PURPOSE: This randomized phase III trial is studying docetaxel and leuprolide or goserelin to see how well they work when given before surgery compared with surgery alone in treating patients with high-risk localized prostate cancer.

Further Study Information

OBJECTIVES:

Primary

  • Compare the rate of 3-year biochemical progression-free survival (bPFS) in patients with high-risk, clinically localized prostate cancer treated with radical prostatectomy with vs without neoadjuvant chemohormonal therapy comprising docetaxel and androgen-deprivation therapy with leuprolide acetate or goserelin.

Secondary

  • Compare the 5-year bPFS rate, bPFS, disease progression, disease-free survival, and overall survival of patients treated with these regimens.
  • Determine the safety and tolerability of neoadjuvant docetaxel and androgen-deprivation therapy in these patients.
  • Compare the time to clinically apparent local disease recurrence and metastatic disease in patients treated with these regimens.
  • Compare pathologic tumor stage, frequency of lymph node metastases, and positive margin rates in patients treated with these regimens.
  • Determine if changes in serum testosterone levels will predict bPFS in these patients.
  • Determine, prospectively, whether prostate-specific antigen doubling time is a surrogate endpoint for time to clinical metastases and overall survival in these patients.

OUTLINE: This is a multicenter, randomized study. Patients are stratified according to nomogram-predicted biochemical progression-free survival at 5 years (0-20.9% vs 21-39.9% vs 40-59.9% vs ≥ 60%) and androgen-deprivation therapy in the past 3 months (no vs yes). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive goserelin subcutaneously or leuprolide acetate intramuscularly once every 4 or 12 weeks for 18-24 weeks (measured from the date of starting docetaxel). They also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 3 weeks for up to 6 courses. Within 60 days after completion of chemohormonal therapy, patients undergo radical prostatectomy with staging pelvic lymphadenectomy.
  • Arm II: Within 60 days after randomization, patients undergo radical prostatectomy with staging pelvic lymphadenectomy.

After completion of study therapy, patients are followed at 1 and 3 months and then periodically for up to 15 years.

PROJECTED ACCRUAL: A total of 750 patients will be accrued for this study.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate
  • No small cell, neuroendocrine, or transitional cell carcinoma
  • Clinically localized, stage T1-3a disease
  • No radiographic evidence of metastatic disease*, as demonstrated by all of the following:
  • No pelvic lymph nodes > 1.5 cm by CT scan or MRI of the abdomen and pelvis or endorectal MRI of the pelvis
  • A negative biopsy required for lymph node(s) that measure > 1.5 cm
  • If > 1 lymph node is > 1.5 cm, the largest or most accessible node is biopsied
  • Negative bone scan with plain films and/or MRI/CT scan confirmation, if necessary NOTE: *Positive positron emission tomography scan and Prostascint scans are not considered proof of metastatic disease
  • Serum prostate-specific antigen level ≤ 100 ng/mL within the past 6 weeks
  • Patients must have a known Gleason sum based on biopsy or TURP at study entry
  • High-risk disease, meeting 1 of the following criteria:
  • Probability of biochemical progression-free survival at 5 years after surgery < 60% by Kattan nomogram prediction
  • Biopsy Gleason score 8 to 10
  • Deemed an appropriate candidate for radical prostatectomy

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy > 10 years
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 150,000/mm^3
  • Creatinine ≤ 2.0 mg/dL
  • Bilirubin normal (≤ 2.5 times upper limit of normal [ULN] for patients with Gilbert's disease)
  • AST and ALT ≤ 1.5 times ULN
  • Fertile patients must use effective contraception during and for ≥ 2 months after completion of study treatment
  • Not at high risk for cardiac complications
  • Prior deep venous thrombosis, pulmonary embolism, and/or cerebrovascular accident allowed

PRIOR CONCURRENT THERAPY:

  • No prior treatment for prostate cancer, including surgery, pelvic lymph node dissection, radiotherapy, or chemotherapy
  • Prior transurethral resection of prostate allowed
  • Prior androgen-deprivation therapy (e.g., luteinizing hormone-releasing hormone agonists, antiandrogens, or both) lasting ≤ 4 months allowed
  • Concurrent systemic anticoagulation allowed
  • No other concurrent systemic therapy, including androgen-deprivation therapy for the treatment of the prostate cancer
  • No concurrent oral antiandrogens
  • No concurrent aprepitant
  • No other concurrent chemotherapeutic agents except for any of the following:
  • Steroids given for adrenal failure
  • Hormones administered for nondisease-related conditions (e.g., insulin for diabetes)
  • Intermittent use of dexamethasone as an antiemetic or as pretreatment for patients receiving docetaxel

Trial Contact Information

Trial Lead Organizations/Sponsors

Cancer and Leukemia Group B

National Cancer Institute

Eastern Cooperative Oncology Group

NCIC-Clinical Trials Group

James A. EasthamStudy Chair

Martin G. SandaStudy Chair

Martin E. GleaveStudy Chair

Trial Sites

U.S.A.
Alabama
  Mobile
 Southern Cancer Center PC-Providence
 Brian J Heller Ph: 877-904-4367
Alaska
  Anchorage
 Alaska Breast Care and Surgery LLC
 Alison K Conlin Ph: 503-215-6412
 Alaska Women's Cancer Care
 Alison K Conlin Ph: 503-215-6412
 Anchorage Oncology Centre
 Alison K Conlin Ph: 503-215-6412
 Katmai Oncology Group
 Alison K Conlin Ph: 503-215-6412
 Providence Cancer Center
 Alison K Conlin Ph: 503-215-6412
  Fairbanks
 Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
 Craig R. Nichols Ph: 503-215-6412
  Email: vmmc.cancer_clinical_research@VirginiaMason.org
California
  Berkeley
 Alta Bates Summit Comprehensive Cancer Center
 Ari D Baron Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  Burlingame
 Peninsula Medical Center
 Ari D Baron Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  Duarte
 City of Hope Comprehensive Cancer Center
 Laura E. Crocitto Ph: 800-826-4673
  Email: becomingapatient@coh.org
 James A. Eastham
  La Jolla
 Rebecca and John Moores UCSD Cancer Center
 James A. Eastham
  Los Angeles
 USC/Norris Comprehensive Cancer Center and Hospital
 David I. Quinn Ph: 323-865-0451
 David I. Quinn Ph: 323-865-0451
  Novato
 Sutter Health Western Division Cancer Research Group
 Ari D Baron Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  Orange
 Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
 Edward M Uchio Ph: 877-827-8839
  Email: ucstudy@uci.edu
  Sacramento
 University of California Davis Cancer Center
 Primo N. Lara Ph: 916-734-3089
  Saint Helena
 Saint Helena Hospital
 Gregory B Smith Ph: 707-967-3698
  San Diego
 Naval Medical Center - San Diego
 Preston S. Gable Ph: 619-532-8712
 Rebecca and John Moores UCSD Cancer Center
 Frederick E Millard Ph: 858-822-5354
  Email: cancercto@ucsd.edu
  San Francisco
 California Pacific Medical Center - California Campus
 Ari D Baron Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  Santa Rosa
 Sutter Pacific Medical Foundation
 Ari D Baron Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  Truckee
 Tahoe Forest Cancer Center
 Primo N. Lara Ph: 916-734-3089
  Vallejo
 Sutter Solano Medical Center
 Ari D Baron Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
Colorado
  Aurora
 University of Colorado Cancer Center at UC Health Sciences Center
 Paul D Maroni Ph: 720-848-0650
  Denver
 University of Colorado Cancer Center at UC Health Sciences Center
 James A. Eastham
 Veterans Affairs Medical Center - Denver
 Paul D Maroni Ph: 720-848-0650
  Edwards
 Shaw Regional Cancer Center
 Alexander T Urquhart Ph: 970-569-7429
  Glenwood Springs
 Valley View Hospital Cancer Center
 Paul D Maroni Ph: 720-848-0650
Connecticut
  Hartford
 Helen and Harry Gray Cancer Center at Hartford Hospital
 Jeffrey M Kamradt Ph: 888-823-5923
  Email: ctsucontact@westat.com
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Philip J. Stella Ph: 734-712-4673
  Meriden
 MidState Medical Center
 Jeffrey M Kamradt Ph: 888-823-5923
  Email: ctsucontact@westat.com
  New Haven
 Yale Cancer Center
 John W Colberg Ph: 203-785-5702
  Norwich
 Eastern Connecticut Hematology and Oncology Associates
 Dennis E. Slater Ph: 860-886-8362
  West Haven
 Veterans Affairs Medical Center - West Haven
 Charles N Walker Ph: 203-937-3421ext2832
Delaware
  Lewes
 Tunnell Cancer Center at Beebe Medical Center
 Stephen Scott Grubbs Ph: 302-733-6227
  Newark
 Christiana Gynecologic Oncology, LLC
 Stephen Scott Grubbs Ph: 302-733-6227
 Delaware Clinical and Laboratory Physicians
 Stephen Scott Grubbs Ph: 302-733-6227
 Helen F. Graham Cancer Center at Christiana Hospital
 Stephen Scott Grubbs Ph: 302-733-6227
 Stephen Scott Grubbs Ph: 302-733-6227
 Medical Oncology Hematology Consultants, PA at Helen F. Graham Cancer Center
 Stephen Scott Grubbs Ph: 302-733-6227
 Regional Hematology/Oncology, PA - Newark
 Stephen Scott Grubbs Ph: 302-733-6227
  Rehoboth Beach
 Beebe Health Campus
 Stephen Scott Grubbs Ph: 302-733-6227
  Seaford
 Nanticoke Memorial Hospital
 Stephen Scott Grubbs Ph: 302-733-6227
  Wilmington
 Christiana Care Health System-Wilmington Hospital
 Stephen Scott Grubbs Ph: 302-733-6227
District of Columbia
  Washington
 Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
 Nancy Ann Dawson Ph: 202-444-0381
Florida
  Altamonte Springs
 Florida Hospital - Altamonte
 Lee M. Zehngebot Ph: 407-303-5623
  Kissimmee
 Florida Hospital Kissimmee
 Lee M. Zehngebot Ph: 407-303-5623
  Miami Beach
 CCOP - Mount Sinai Medical Center
 Michael Schwartz Ph: 305-674-2625
  Email: info@msccop.com
  Orlando
 Florida Hospital Cancer Institute at Florida Hospital Orlando
 Lee M. Zehngebot Ph: 407-303-5623
 Florida Hospital East Orlando
 Lee M. Zehngebot Ph: 407-303-5623
 Florida Urology Associates-Orlando
 Lee M. Zehngebot Ph: 407-303-5623
  Weston
 Cleveland Clinic Florida - Weston
 Nicolas A Muruve Ph: 954-659-5705
  Winter Park
 Florida Hospital Cancer Institute at Winter Park
 Lee M. Zehngebot Ph: 407-303-5623
Georgia
  Columbus
 John B. Amos Cancer Center
 Andrew W. Pippas Ph: 706-660-6404
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Philip J. Stella Ph: 734-712-4673
  Lewiston
 St. Joseph Regional Medical Center
 Yoshio Inoue Ph: 800-351-7955
  Post Falls
 Kootenai Cancer Center - Post Falls
 Benjamin Thomas Marchello Ph: 800-648-6274
Illinois
  Carbondale
 Memorial Hospital of Carbondale
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Centralia
 Centralia Oncology Clinic
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Chicago
 Cancer and Leukemia Group B
 James A. Eastham Ph: 646-422-4390
  Email: easthamj@mskcc.org
 University of Chicago Cancer Research Center
 David VanderWeele Ph: 773-834-7424
  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
 Crossroads Cancer Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Hines
 Veterans Affairs Medical Center - Hines
 Nirmala Bhoopalam Ph: 708-202-8387
  Maywood
 Cardinal Bernardin Cancer Center at Loyola University Medical Center
 Ellen R. Gaynor Ph: 708-226-4357
  Springfield
 Regional Cancer Center at Memorial Medical Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
Indiana
  Elkhart
 Elkhart Clinic, LLC
 Rafat H. Ansari Ph: 574-234-5123
 Michiana Hematology-Oncology, PC - Elkhart
 Rafat H. Ansari Ph: 574-234-5123
  Mishawaka
 Memorial Regional Cancer Center Day Road
 Thomas Joseph Reid Ph: 800-284-7370
 Michiana Hematology-Oncology, PC - Mishawaka
 Rafat H. Ansari Ph: 574-234-5123
 Saint Joseph's Medical Center
 Rafat H. Ansari Ph: 574-234-5123
  Plymouth
 Michiana Hematology Oncology PC - Plymouth
 Rafat H. Ansari Ph: 574-234-5123
  South Bend
 CCOP - Northern Indiana CR Consortium
 Rafat H. Ansari Ph: 574-234-5123
 Memorial Hospital of South Bend
 Thomas Joseph Reid Ph: 800-284-7370
 Michiana Hematology-Oncology, PC - South Bend
 Rafat H. Ansari Ph: 574-234-5123
  Westville
 Michiana Hematology Oncology-PC Westville
 Rafat H. Ansari Ph: 574-234-5123
Iowa
  Bettendorf
 Hematology Oncology Associates of the Quad Cities
 Shobha R. Chitneni Ph: 563-355-7733
  Email: kedaprile@rccqc.com
  Davenport
 Genesis Regional Cancer Center at Genesis Medical Center
 George Kovach Ph: 800-446-6088
  Email: werners@genesishealth.com
  Iowa City
 Holden Comprehensive Cancer Center at University of Iowa
 Daniel A Vaena Ph: 800-237-1225
Kansas
  Emporia
 Newman Regional Health
 Peter J. VanVeldhuizen Ph: 800-525-1483
  Garden City
 St. Catherine Hospital Cancer Center
 Peter J. VanVeldhuizen Ph: 800-525-1483
  Great Bend
 St. Rose Ambulatory and Surgery Center
 Peter J. VanVeldhuizen Ph: 800-525-1483
  Hays
 Hays Medical Center
 Peter J. VanVeldhuizen Ph: 800-525-1483
  Kansas City
 Kansas City Cancer Centers - West
 Peter J. VanVeldhuizen Ph: 800-525-1483
 Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
 Peter J. VanVeldhuizen Ph: 800-525-1483
  Overland Park
 Kansas City Cancer Centers - Southwest
 Peter J. VanVeldhuizen Ph: 800-525-1483
  Pittsburg
 Mount Carmel Regional Cancer Center
 Peter J. VanVeldhuizen Ph: 800-525-1483
  Salina
 Tammy Walker Cancer Center at Salina Regional Health Center
 Peter J. VanVeldhuizen Ph: 800-525-1483
  Topeka
 St. Francis Comprehensive Cancer Center
 Peter J. VanVeldhuizen Ph: 800-525-1483
Louisiana
  Baton Rouge
 Mary Bird Perkins Cancer Center - Baton Rouge
 Augusto C Ochoa Ph: 504-568-2428
  Email: emede1@lsuhsc.edu
  Metairie
 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
 Tulane Cancer Center at Tulane University Hospital and Clinic
 Hana F Safah Ph: 504-988-6121
  Shreveport
 Feist-Weiller Cancer Center at Louisiana State University Health Sciences
 James A. Eastham
Maine
  Scarborough
 Maine Center for Cancer Medicine and Blood Disorders - Scarborough
 Frederick R. Aronson
  Email: research@newecs.org
Maryland
  Bethesda
 National Naval Medical Center
 David C Van Echo Ph: 301-319-2100
  Salisbury
 Peninsula Regional Medical Center
 Paul E Zorsky Ph: 410-543-7017
  Email: sandra.heineken@peninsula.org
Massachusetts
  Boston
 Tufts Medical Center Cancer Center
 Paul Mathew Ph: 617-636-5000
  Email: ContactUsCancerCenter@TuftsMedicalCenter.org
  Pittsfield
 Berkshire Hematology Oncology, PC
 Harvey Zimbler Ph: 413-496-8205
  Email: ggero@bhs1.org
Michigan
  Ann Arbor
 Saint Joseph Mercy Cancer Center
 Philip J. Stella Ph: 734-712-4673
  Battle Creek
 Battle Creek Health System Cancer Care Center
 Gilbert D Padula Ph: 616-685-5225
  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
 Lacks Cancer Center at Saint Mary's Health Care
 Gilbert D Padula Ph: 616-685-5225
  Jackson
 Gayle M. Jacob Cancer Center at Allegiance Health
 Philip J. Stella Ph: 734-712-4673
  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
  Niles
 Lakeland Hospital - Niles
 Rafat H. Ansari Ph: 574-234-5123
  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
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Philip J. Stella Ph: 734-712-4673
  Saint Joseph
 Lakeside Cancer Specialists, PLLC
 Rafat H. Ansari Ph: 574-234-5123
  St. Joseph
 Lakeland Regional Cancer Care Center - St. Joseph
 Rafat H. Ansari Ph: 574-234-5123
  Traverse City
 Munson Medical Center
 Gilbert D Padula Ph: 616-685-5225
  Warren
 St. John Macomb Hospital
 Philip J. Stella Ph: 734-712-4673
Minnesota
  Burnsville
 Fairview Ridges Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Coon Rapids
 Mercy and Unity Cancer Center at Mercy Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Edina
 Fairview Southdale Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Fridley
 Mercy and Unity Cancer Center at Unity Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Hutchinson
 Hutchinson Area Health Care
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Maplewood
 HealthEast Cancer Care at St. John's Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Minnesota Oncology - Maplewood
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Minneapolis
 Health Partners Inc
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Hennepin County Medical Center - Minneapolis
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Masonic Cancer Center at University of Minnesota
 Bruce A. Peterson Ph: 612-624-2620
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  New Ulm
 New Ulm Medical Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Robbinsdale
 Humphrey Cancer Center at North Memorial Outpatient Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Saint Cloud
 CentraCare Clinic - Women and Children
 Donald J Jurgens Ph: 877-229-4907
  Email: coborncancercenter@centracare.com
 Coborn Cancer Center
 Donald J Jurgens Ph: 877-229-4907
  Email: coborncancercenter@centracare.com
  Saint Louis Park
 Park Nicollet Cancer Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Saint Paul
 Regions Hospital Cancer Care Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 United Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Shakopee
 St. Francis Cancer Center at St. Francis Medical Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Stillwater
 Lakeview Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Waconia
 Ridgeview Medical Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Willmar
 Willmar Cancer Center at Rice Memorial Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Woodbury
 Minnesota Oncology - Woodbury
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
Mississippi
  Hattiesburg
 Forrest General Cancer Center at Forrest General Hospital
 Augusto C Ochoa Ph: 504-568-2428
  Email: emede1@lsuhsc.edu
 Hattiesburg Clinic, PA at Forrest General
 Augusto C Ochoa Ph: 504-568-2428
  Email: emede1@lsuhsc.edu
  Jackson
 University of Mississippi Cancer Clinic
 Robert D Hamilton Ph: 601-815-6700
Missouri
  Cape Girardeau
 Saint Francis Medical Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Kansas City
 Kansas City Cancer Centers - North
 Peter J. VanVeldhuizen Ph: 800-525-1483
 Kansas City Cancer Centers - South
 Peter J. VanVeldhuizen Ph: 800-525-1483
 Truman Medical Center - Hospital Hill
 Peter J. VanVeldhuizen Ph: 800-525-1483
 Veterans Affairs Medical Center - Kansas City
 Peter J. VanVeldhuizen Ph: 800-525-1483
  Lee's Summit
 Kansas City Cancer Centers - East
 Peter J. VanVeldhuizen Ph: 800-525-1483
  Saint Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Joel Picus Ph: 800-600-3606
  Email: info@siteman.wustl.edu
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
 Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
 Benjamin Thomas Marchello Ph: 800-648-6274
Nebraska
  Lincoln
 Cancer Resource Center - Lincoln
 Gamini S. Soori Ph: 402-991-8070ext202
  Email: mwilwerding@mvcc.cc
 Nebraska Hematology and Oncology
 Gamini S. Soori Ph: 402-398-6060
  Norfolk
 Carson Cancer Center at Faith Regional Hospital
 Gamini S. Soori Ph: 402-991-8070ext202
  Email: mwilwerding@mvcc.cc
  North Platte
 Callahan Cancer Center at Great Plains Regional Medical Center
 Gamini S. Soori Ph: 402-280-4100
  Omaha
 CCOP - Missouri Valley Cancer Consortium
 Gamini S. Soori Ph: 402-991-8070ext202
  Email: mwilwerding@mvcc.cc
 Oncology Hematology West PC
 Gamini S. Soori Ph: 402-398-6060
 Oncology Hematology West, PC - Omaha Bergan
 Gamini S. Soori Ph: 402-398-6060
  Scottsbluff
 Cancer Treatment Center at Regional West Medical Center
 Gamini S. Soori Ph: 402-991-8070ext202
  Email: mwilwerding@mvcc.cc
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
 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
 University Medical Center of Southern Nevada
 John Allan Ellerton Ph: 702-384-0013
New Hampshire
  Concord
 New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
 Douglas Jay Weckstein Ph: 603-224-2556
  Derry
 Parkland Oncology at Parkland Medical Center
 Lata C Thatai Ph: 781-744-8027
  Exeter
 Center for Cancer Care at Exeter Hospital
 Michael S Buff Ph: 800-339-6484
  Hooksett
 New Hampshire Oncology - Hematology, PA - Hooksett
 Douglas Jay Weckstein Ph: 603-224-2556
  Lebanon
 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
 John D Seigne Ph: 800-639-6918
  Email: cancer.research.nurse@dartmouth.edu
New Jersey
  Basking Ridge
 Memorial Sloan-Kettering Cancer Center - Basking Ridge
 James A. Eastham Ph: 212-639-7202
  Camden
 Cancer Institute of New Jersey at Cooper University Hospital - Camden
 Robert A Somer Ph: 856-325-6757
  Morristown
 Carol G. Simon Cancer Center at Morristown Memorial Hospital
 Stacey B Leibowitz Ph: 973-971-5900
  Somerville
 Somerset Medical Center
 Steven E Young Ph: 908-685-2481
  Sparta
 Frederick R. and Betty M. Smith Cancer Treatment Center
 Edouard J Trabulsi Ph: 215-955-6084
  Summit
 Overlook Hospital
 Stacey B Leibowitz Ph: 973-971-5900
  Voorhees
 Cancer Institute of New Jersey at Cooper - Voorhees
 Robert A Somer Ph: 856-325-6757
New Mexico
  Albuquerque
 Hematology Oncology Associates, PC
 Richard C Lauer Ph: 505-272-6972
 Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital
 Richard C Lauer Ph: 505-272-6972
 University of New Mexico Cancer Center
 Richard C Lauer Ph: 505-272-6972
 James A. Eastham
New York
  Buffalo
 Roswell Park Cancer Institute
 James L. Mohler Ph: 877-275-7724
  Commack
 Memorial Sloan-Kettering Cancer Center
 James A. Eastham Ph: 212-639-7202
  New York
 Memorial Sloan-Kettering Cancer Center
 James A. Eastham Ph: 212-639-7202
 New York Weill Cornell Cancer Center at Cornell University
 Scott Tagawa Ph: 212-746-1848
  Rochester
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Jonathan W Friedberg Ph: 585-275-5830
  Syracuse
 SUNY Upstate Medical University Hospital
 Bernard J. Poiesz Ph: 315-464-5476
North Carolina
  Charlotte
 Blumenthal Cancer Center at Carolinas Medical Center
 John F. Mahoney Ph: 704-355-2884
  Clinton
 Southeastern Medical Oncology Center-Clinton
 James N. Atkins Ph: 919-580-0000
  Durham
 Duke Cancer Institute
 Jeffrey Crawford Ph: 888-275-3853
  Goldsboro
 Southeastern Medical Oncology Center - Goldsboro
 James N. Atkins Ph: 919-580-0000
 Wayne Memorial Hospital, Incorporated
 James N. Atkins Ph: 919-580-0000
  Hendersonville
 Park Ridge Hospital Breast Health Center
 Charles E Bowers Ph: 800-486-5941
  Jacksonville
 Southeastern Medical Oncology Center-Jacksonville
 James N. Atkins Ph: 919-580-0000
  Kernersville
 Novant Health Oncology Specialists-Kernersville
 Judith Owen Hopkins Ph: 336-277-8887
  Kinston
 Kinston Medical Specialists
 Peter R. Watson Ph: 252-559-2200
  Lexington
 Novant Health Oncology Specialists-Davidson County
 Judith Owen Hopkins Ph: 336-277-8887
  Monroe
 Edwards Cancer Center at Union Regional Medical Center
 John F. Mahoney Ph: 704-355-2884
  Mount Airy
 Novant Health Oncology Specialists-Mount Airy
 Judith Owen Hopkins Ph: 336-277-8887
  Raleigh
 Duke Health Raleigh Hospital
 Jeffrey Crawford Ph: 888-275-3853
  Shelby
 Cleveland Regional Medical Center
 John F. Mahoney Ph: 704-355-2884
  Statesville
 Iredell Memorial Hospital
 Ruby A. Grimm Ph: 704-873-5661
  Stateville
 Novant Health Oncology Specialists-Statesville
 Judith Owen Hopkins Ph: 336-277-8887
  Wilkesboro
 Novant Health Oncology Specialists-Wilkesboro
 Judith Owen Hopkins Ph: 336-277-8887
  Wilson
 Southeastern Medical Oncology Center - Wilson
 James N. Atkins Ph: 919-580-0000
  Winston-Salem
 Forsyth Regional Cancer Center at Forsyth Medical Center
 Judith Owen Hopkins Ph: 336-277-8887
 Piedmont Hematology-Oncology Associates
 Judith Owen Hopkins Ph: 336-277-8887
 Wake Forest University Comprehensive Cancer Center
 Kethandapatti C Balaji Ph: 336-713-6771
 Winston-Salem Health Care
 Judith Owen Hopkins Ph: 336-277-8887
Ohio
  Cleveland
 MetroHealth Cancer Care Center at MetroHealth Medical Center
 Bruce J. Averbook Ph: 216-778-8526
  Email: kbauchens@metrohealth.org
  Columbus
 Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
 J. Paul Monk Ph: 866-627-7616
  Email: osu@emergingmed.com
 James A. Eastham
  Lima
 St. Rita's Medical Center
 Henry Gerad Ph: 419-226-9617
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Sindhu Singh Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
  Tulsa
 Cancer Care Associates-Yale
 Sindhu Singh Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Oregon
  Clackamas
 Clackamas Radiation Oncology Center
 Alison K Conlin Ph: 503-215-6412
  Coos Bay
 Bay Area Hospital
 Bret A. Cook Ph: 541-269-8392
  Email: cherie.cox@bayareahospital.org
  Newberg
 Providence Newberg Medical Center
 Alison K Conlin Ph: 503-215-6412
  Oregon City
 Willamette Falls Hospital
 Alison K Conlin Ph: 503-215-6412
  Portland
 Kaiser Permanente Health Care - Portland
 Nagendra Tirumali Ph: 503-335-2400
 Knight Cancer Institute at Oregon Health and Science University
 Christopher W. Ryan Ph: 503-494-1080
  Email: trials@ohsu.edu
 Providence Cancer Center at Providence Portland Medical Center
 Alison K Conlin Ph: 503-215-6412
 Providence St. Vincent Medical Center
 Alison K Conlin Ph: 503-215-6412
Pennsylvania
  Darby
 Mercy Fitzgerald Hospital
 Edouard J Trabulsi Ph: 215-955-6084
  Philadelphia
 Fox Chase Cancer Center - Philadelphia
 Rosalia Viterbo Ph: 215-728-4790
 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
 Edouard J Trabulsi Ph: 215-955-6084
South Carolina
  Anderson
 AnMed Cancer Center
 Charles E Bowers Ph: 800-486-5941
 Charles E Bowers Ph: 800-486-5941
  Charleston
 Charleston Hematology Oncology Associates PA-St. Francis
 James Michael Orcutt Ph: 843-720-8386
  Email: elizabeth.strojny@roperstfrancis.com
 Charleston Hematology Oncology Associates, PA
 James Michael Orcutt Ph: 843-720-8386
  Email: elizabeth.strojny@roperstfrancis.com
 Lowcountry Hematology Oncology PA-Charleston
 James Michael Orcutt Ph: 843-720-8386
  Email: elizabeth.strojny@roperstfrancis.com
 Lowcountry Hematology Oncology PA-West Ashley
 James Michael Orcutt Ph: 843-720-8386
  Email: elizabeth.strojny@roperstfrancis.com
 Roper St. Francis Cancer Center at Roper Hospital
 James Michael Orcutt Ph: 843-720-8386
  Email: elizabeth.strojny@roperstfrancis.com
  Greenville
 Bon Secours St. Francis Health System
 Charles E Bowers Ph: 800-486-5941
 CCOP - Greenville
 Jeffrey Kent Giguere Ph: 864-241-6251
  Greer
 Gibbs Cancer Center-Pelham
 Charles E Bowers Ph: 800-486-5941
  Lancaster
 Carolina Blood and Cancer Care Associates, PA
 Charles E Bowers Ph: 800-486-5941
  Mount Pleasant
 Lowcountry Hematology and Oncology, PA
 James Michael Orcutt Ph: 843-720-8386
  Email: elizabeth.strojny@roperstfrancis.com
  Rock Hill
 Carolina Blood and Cancer Care
 Charles E Bowers Ph: 800-486-5941
  Spartanburg
 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
 Charles E Bowers Ph: 800-486-5941
Tennessee
  Bristol
 Wellmont-Bristol Regional Medical Center
 Asheesh Shipstone Ph: 423-578-8538
  Johnson City
 Wellmont Medical Associates Oncology and Hematology-Johnson City
 Asheesh Shipstone Ph: 423-578-8538
  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
  Nashville
 MBCCOP - Meharry Medical College - Nashville
 John J Murray Ph: 615-327-5724
  Email: jmurray@mmc.edu
Texas
  Austin
 Texas Oncology - Midtown Austin
 Beth A Hellerstedt Ph: 512-341-8724
 Texas Oncology, PA - Austin North
 Beth A Hellerstedt Ph: 512-341-8724
 Texas Oncology, PA at South Austin Cancer Center
 Beth A Hellerstedt Ph: 512-341-8724
 Texas Oncology, PA at Texas Oncology Cancer Center - Central
 Beth A Hellerstedt Ph: 512-341-8724
  Cedar Park
 Texas Oncology, PA - Cedar Park
 Beth A Hellerstedt Ph: 512-341-8724
  Round Rock
 Texas Oncology, PA - Seton Williamson
 Beth A Hellerstedt Ph: 512-341-8724
 Texas Oncology, PA at Texas Cancer Center Round Rock
 Beth A Hellerstedt Ph: 512-341-8724
  San Marcos
 Texas Oncology, PA - San Marcos
 Beth A Hellerstedt Ph: 512-341-8724
Virginia
  Norton
 Southwest Virginia Regional Cancer Center at Wellmonth Health
 Asheesh Shipstone Ph: 423-578-8538
Washington
  Auburn
 Auburn Regional Center for Cancer Care
 Yoshio Inoue Ph: 800-351-7955
  Bellevue
 Overlake Cancer Center at Overlake Hospital Medical Center
 Yoshio Inoue Ph: 800-351-7955
  Centralia
 Providence Centralia Hospital
 Yoshio Inoue Ph: 800-351-7955
  Everett
 Providence Regional Cancer Partnership
 Yoshio Inoue Ph: 800-351-7955
  Lacey
 Western Washington Oncology, Incorporated, PS at Western Washington Cancer Center
 Yoshio Inoue Ph: 800-351-7955
  Longview
 Lower Columbia Regional Cancer Center at PeaceHealth-St. John Medical Center
 Alison K Conlin Ph: 503-215-6412
  Puyallup
 Good Samaritan Cancer Center
 Yoshio Inoue Ph: 800-351-7955
  Seattle
 CCOP - Virginia Mason Research Center
 Craig R. Nichols Ph: 503-215-6412
  Email: vmmc.cancer_clinical_research@VirginiaMason.org
 Pacific Medical Center
 Craig R. Nichols Ph: 503-215-6412
  Email: vmmc.cancer_clinical_research@VirginiaMason.org
  Tacoma
 Madigan Army Medical Center - Tacoma
 Timothy C Brand Ph: 253-968-0129
  Email: mamcdci@amedd.army.mil
 MultiCare Regional Cancer Center at Tacoma General Hospital
 Yoshio Inoue Ph: 800-351-7955
 Northwest Medical Specialties, PLLC - Tacoma
 Yoshio Inoue Ph: 800-351-7955
  Vancouver
 Southwest Washington Medical Center Cancer Center
 Alison K Conlin Ph: 503-215-6412
West Virginia
  Charleston
 West Virginia University Medical School - Charleston
 Steven J. Jubelirer Ph: 304-344-3457
  Huntington
 Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
 Maria-Rosalia B. Tria Tirona Ph: 304-399-6617
Wisconsin
  Burlington
 Aurora Cancer Care-Burlington
 Dhimant R. Patel Ph: 800-252-2990
  Elkhorn
 Vince Lombardi Cancer Center at Aurora Lakeland Medical Center - Elkhorn
 Dhimant R. Patel Ph: 800-252-2990
  Grafton
 Aurora Cancer Care-Grafton
 Dhimant R. Patel Ph: 800-252-2990
  Green Bay
 Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
 Dhimant R. Patel Ph: 800-252-2990
  Kenosha
 Oncology Alliance - Kenosha South
 Dhimant R. Patel Ph: 800-252-2990
  La Crosse
 Gundersen Lutheran Center for Cancer and Blood
 Kurt Oettel Ph: 608-775-2385
  Email: cancerctr@gundluth.org
  Marinette
 Vince Lombardi Cancer Clinic - Marinette
 Dhimant R. Patel Ph: 800-252-2990
  Menomonee Falls
 Aurora Advanced Healthcare Inc-Menomonee Falls
 Dhimant R. Patel Ph: 800-252-2990
  Milwaukee
 Aurora Cancer Care-Milwaukee
 Dhimant R. Patel Ph: 800-252-2990
 Aurora Sinai Medical Center
 Dhimant R. Patel Ph: 800-252-2990
 Oncology Alliance, SC - Milwaukee - South
 Dhimant R. Patel Ph: 800-252-2990
 Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
 Dhimant R. Patel Ph: 800-252-2990
  New Richmond
 Cancer Center of Western Wisconsin
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Oshkosh
 Vince Lombardi Cancer Clinic - Oshkosh
 Dhimant R. Patel Ph: 800-252-2990
  Racine
 Aurora Health Center - Racine
 Dhimant R. Patel Ph: 800-252-2990
  Sheboygan
 Vince Lombardi Cancer Clinic - Sheboygan
 Dhimant R. Patel Ph: 800-252-2990
  Summit
 Aurora Medical Center
 Dhimant R. Patel Ph: 800-252-2990
  Two Rivers
 Vince Lombardi Cancer Clinic - Two Rivers
 Dhimant R. Patel Ph: 800-252-2990
  Waukesha
 Aurora Cancer Care-Waukesha
 Dhimant R. Patel Ph: 800-252-2990
  Wauwatosa
 Oncology Alliance, SC - Milwaukee - West
 Dhimant R. Patel Ph: 800-252-2990
  West Allis
 Aurora Women's Pavilion of West Allis Memorial Hospital
 Dhimant R. Patel Ph: 800-252-2990
Wyoming
  Sheridan
 Welch Cancer Center at Sheridan Memorial Hospital
 Benjamin Thomas Marchello Ph: 800-648-6274
Canada
Alberta
  Calgary
 Tom Baker Cancer Centre - Calgary
 Joseph D Ruether Ph: 403-521-3433
British Columbia
  Vancouver
 Vancouver Coastal Health
 Martin E. Gleave Ph: 888-939-3333
Manitoba
  Winnipeg
 CancerCare Manitoba
 Darrel E Drachenberg Ph: 866-561-1026
  Email: CIO_Web@cancercare.mb.ca
Ontario
  London
 London Regional Cancer Program at London Health Sciences Centre
 Joseph L Chin Ph: 519-685-8600
  Toronto
 Princess Margaret Hospital
 Alexandre R Zlotta Ph: 416-946-4501
  Email: clinical.trials@uhn.on.ca

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00430183
ClinicalTrials.gov processed this data on November 12, 2014

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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