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

Basic Trial Information

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

James A. Eastham

Study Chair

Martin G. Sanda

Study Chair

Martin E. Gleave

Study Chair

U.S.A.
Alaska
	Anchorage
	Providence Cancer Center
		Jeanne E. Anderson	Ph: 907-261-3109
	Fairbanks
	Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
		Craig R. Nichols	Ph: 503-215-6412
California
	Berkeley
	Alta Bates Summit Comprehensive Cancer Center
		David H. Irwin	Ph: 510-204-3428
	Burlingame
	Peninsula Medical Center
		David H. Irwin	Ph: 510-204-3428
	Greenbrae
	Sutter Health Western Division Cancer Research Group
		David H. Irwin	Ph: 510-204-3428
	Los Angeles
	USC/Norris Comprehensive Cancer Center and Hospital
		David I. Quinn	Ph: 323-865-0451
		David I. Quinn	Ph: 323-865-0451
	Sacramento
	University of California Davis Cancer Center
		Primo N. Lara	Ph: 916-734-3089
	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
		David H. Irwin	Ph: 510-204-3428
	Santa Rosa
	Sutter Pacific Medical Foundation
		David H. Irwin	Ph: 510-204-3428
	Truckee
	Tahoe Forest Cancer Center
		Primo N. Lara	Ph: 916-734-3089
	Vallejo
	Sutter Solano Medical Center
		David H. Irwin	Ph: 510-204-3428
Colorado
	Aurora
	University of Colorado Cancer Center at UC Health Sciences Center
		Paul D Maroni	Ph: 720-848-0650
	Denver
	Denver Health Medical Center
		Paul D Maroni	Ph: 720-848-0650
	Veterans Affairs Medical Center - Denver
		Paul D Maroni	Ph: 720-848-0650
	Edwards
	Shaw Regional Cancer Center
		Paul D Maroni	Ph: 720-848-0650
	Glenwood Springs
	Valley View Hospital Cancer Center
		Paul D Maroni	Ph: 720-848-0650
	Montrose
	Montrose Memorial Hospital Cancer Center
		Paul D Maroni	Ph: 720-848-0650
Connecticut
	Hartford
	Helen and Harry Gray Cancer Center at Hartford Hospital
		Robert D. Siegel	Ph: 860-545-5363
	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
		Philip J. Stella	Ph: 734-712-3456
	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
	Helen F. Graham Cancer Center at Christiana Hospital
		Stephen Scott Grubbs	Ph: 302-733-6227
Florida
	Fort Lauderdale
	Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
		Michael Schwartz	Ph: 305-674-2625
			Email: info@msccop.com
	Jupiter
	Ella Milbank Foshay Cancer Center at Jupiter Medical Center
		Michael Schwartz	Ph: 305-674-2625
			Email: info@msccop.com
	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
	Weston
	Cleveland Clinic Florida - Weston
		Nicolas A Muruve	Ph: 954-659-5705
Hawaii
	Aiea
	Kapiolani Medical Center at Pali Momi
		Jeffrey L. Berenberg	Ph: 808-586-2979
	Honolulu
	Cancer Research Center of Hawaii
		Jeffrey L. Berenberg	Ph: 808-586-2979
	Hawaii Medical Center - East
		Jeffrey L. Berenberg	Ph: 808-586-2979
	Kapiolani Medical Center for Women and Children
		Jeffrey L. Berenberg	Ph: 808-586-2979
	OnCare Hawaii, Incorporated - Kuakini
		Jeffrey L. Berenberg	Ph: 808-586-2979
	OnCare Hawaii, Incorporated - Lusitana
		Jeffrey L. Berenberg	Ph: 808-586-2979
	Queen's Cancer Institute at Queen's Medical Center
		Jeffrey L. Berenberg	Ph: 808-586-2979
	Straub Clinic and Hospital, Incorporated
		Jeffrey L. Berenberg	Ph: 808-586-2979
	Kailua
	Castle Medical Center
		Jeffrey L. Berenberg	Ph: 808-586-2979
	Lihue
	Kauai Medical Clinic
		Jeffrey L. Berenberg	Ph: 808-586-2979
	Wailuku
	Maui Memorial Medical Center
		Jeffrey L. Berenberg	Ph: 808-586-2979
	Pacific Cancer Institute - Maui
		Jeffrey L. Berenberg	Ph: 808-586-2979
Idaho
	Boise
	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
		Philip J. Stella	Ph: 734-712-3456
	Meridian
	Idaho Urologic Institute, PA
		Philip J. Stella	Ph: 734-712-3456
Illinois
	Chicago
	Cancer and Leukemia Group B
		James A. Eastham	Ph: 646-422-4390
			Email: easthamj@mskcc.org
	Louis A. Weiss Memorial Hospital
		Keith L. Shulman	Ph: 773-564-5044
	University of Chicago Cancer Research Center
		Walter M. Stadler	Ph: 773-834-7424
	Decatur
	Decatur Memorial Hospital Cancer Care Institute
		James L. Wade	Ph: 217-876-4740
			Email: kcheek@dmhhs.org
	Geneva
	Delnor Hospital - Geneva
		Christopher M. George	Ph: 630-232-0610
	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
	Warrenville
	Central Dupage Cancer Center
		Michael Kahn	Ph: 630-352-5300
Indiana
	Elkhart
	Elkhart Clinic, LLC
		Rafat H. Ansari	Ph: 574-234-5123
	Elkhart General Hospital
		Rafat H. Ansari	Ph: 574-234-5123
	Michiana Hematology-Oncology, PC - Elkhart
		Rafat H. Ansari	Ph: 574-234-5123
	Kokomo
	Community Cancer Care at Howard Regional Health System
		Rafat H. Ansari	Ph: 574-234-5123
	La Porte
	Center for Cancer Therapy at LaPorte Hospital and Health Services
		Rafat H. Ansari	Ph: 574-234-5123
	Mishawaka
	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
		Rafat H. Ansari	Ph: 574-234-5123
	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
	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
	Hutchinson
	Hutchinson Hospital Corporation
		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
	Shawnee Mission
	Kansas City Cancer Center - Shawnee Mission
		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
		Robert W Veith	Ph: 504-568-3410
			Email: aconne1@lsuhsc.edu
	Pennington Cancer Center at Baton Rouge General
		Robert W Veith	Ph: 504-568-3410
			Email: aconne1@lsuhsc.edu
	New Orleans
	Medical Center of Louisiana - New Orleans
		Robert W Veith	Ph: 504-568-3410
			Email: aconne1@lsuhsc.edu
	Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans
		Robert W Veith	Ph: 504-568-3410
			Email: aconne1@lsuhsc.edu
Maine
	Scarborough
	Maine Center for Cancer Medicine and Blood Disorders - Scarborough
		Tracey Farrell Weisberg	Ph: 207-396-7600
Maryland
	Elkton MD
	Union Hospital of Cecil County
		Stephen Scott Grubbs	Ph: 302-733-6227
	Salisbury
	Peninsula Regional Medical Center
		Joseph A. Grasso	Ph: 410-543-7000
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: Gloria.Gero@berkshirehemonc.com
Michigan
	Ann Arbor
	CCOP - Michigan Cancer Research Consortium
		Philip J. Stella	Ph: 734-712-3456
	Saint Joseph Mercy Cancer Center
		Philip J. Stella	Ph: 734-712-3456
	Battle Creek
	Battle Creek Health System Cancer Care Center
		Gilbert D Padula	Ph: 616-685-5225
	Big Rapids
	Mecosta County Medical Center
		Gilbert D Padula	Ph: 616-685-5225
	Dearborn
	Oakwood Cancer Center at Oakwood Hospital and Medical Center
		Philip J. Stella	Ph: 734-712-3456
	Detroit
	Josephine Ford Cancer Center at Henry Ford Hospital
		Robert Anthony Chapman	Ph: 313-916-1784
	Van Elslander Cancer Center at St. John Hospital and Medical Center
		Philip J. Stella	Ph: 734-712-3456
	Wayne State University
		Ulka N. Vaishampayan	Ph: 313-576-9363
	Flint
	Genesys Hurley Cancer Institute
		Philip J. Stella	Ph: 734-712-3456
	Hurley Medical Center
		Philip J. Stella	Ph: 734-712-3456
	Grand Rapids
	Butterworth Hospital at Spectrum Health
		Gilbert D Padula	Ph: 616-685-5225
	CCOP - Grand Rapids
		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: 734-712-3456
	Lansing
	Sparrow Regional Cancer Center
		Philip J. Stella	Ph: 734-712-3456
	Livonia
	St. Mary Mercy Hospital
		Philip J. Stella	Ph: 734-712-3456
	Muskegon
	Mercy General Health Partners
		Gilbert D Padula	Ph: 616-685-5225
	Pontiac
	St. Joseph Mercy Oakland
		Philip J. Stella	Ph: 734-712-3456
	Port Huron
	Mercy Regional Cancer Center at Mercy Hospital
		Philip J. Stella	Ph: 734-712-3456
	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: 734-712-3456
	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: 734-712-3456
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
	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
	CCOP - Metro-Minnesota
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	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
	Jackson
	University of Mississippi Cancer Clinic
		Robert D Hamilton	Ph: 601-815-6700
Missouri
	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
	Hematology-Oncology Centers of the Northern Rockies - Billings
		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
		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
		Grant William Harrer	Ph: 406-731-8217
	Great Falls Clinic - Main Facility
		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
	Montana Cancer Specialists at Montana Cancer Center
		Benjamin Thomas Marchello	Ph: 800-648-6274
Nebraska
	Lincoln
	Cancer Resource Center - Lincoln
		Gamini S. Soori	Ph: 800-253-4368
	Omaha
	Alegant Health Cancer Center at Bergan Mercy Medical Center
		Gamini S. Soori	Ph: 800-253-4368
	CCOP - Missouri Valley Cancer Consortium
		Gamini S. Soori	Ph: 800-253-4368
	Creighton University Medical Center
		Gamini S. Soori	Ph: 800-253-4368
	Immanuel Medical Center
		Gamini S. Soori	Ph: 800-253-4368
	Lakeside Hospital
		Gamini S. Soori	Ph: 800-253-4368
	Methodist Estabrook Cancer Center
		Robert M. Langdon	Ph: 402-354-5144
Nevada
	Las Vegas
	CCOP - Nevada Cancer Research Foundation
		John Allan Ellerton	Ph: 702-731-8274
	University Medical Center of Southern Nevada
		John Allan Ellerton	Ph: 702-731-8274
New Hampshire
	Concord
	New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
		Frederick M. Briccetti	Ph: 800-339-6484
	Hooksett
	New Hampshire Oncology - Hematology, PA - Hooksett
		Frederick M. Briccetti	Ph: 800-339-6484
	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
	Camden
	Cancer Institute of New Jersey at Cooper University Hospital - Camden
		Stephen Scott Grubbs	Ph: 302-733-6227
	Morristown
	Carol G. Simon Cancer Center at Morristown Memorial Hospital
		Steven William Papish	Ph: 973-971-5900
	Mount Holly
	Virtua Fox Chase Health Cancer Program at Virtua Memorial Hospital Burlington County
		Michael S. Entmacher	Ph: 888-847-8823
	Somerville
	Somerset Medical Center
		Jovenia S Celo	Ph: 908-685-2481
	Sparta
	Frederick R. and Betty M. Smith Cancer Treatment Center
		Edouard J Trabulsi	Ph: 215-955-6084
	Summit
	Overlook Hospital
		Steven William Papish	Ph: 973-971-5900
	Voorhees
	Fox Chase Virtua Health Cancer Program at Virtua West Jersey
		Michael S. Entmacher	Ph: 888-847-8823
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
New York
	Buffalo
	Roswell Park Cancer Institute
		James L. Mohler	Ph: 877-275-7724
	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
	Presbyterian Cancer Center at Presbyterian Hospital
		Justin P Favaro	Ph: 704-384-5369
	Durham
	Duke Cancer Institute
		Jeffrey Crawford	Ph: 888-275-3853
	Goldsboro
	Wayne Memorial Hospital, Incorporated
		James N. Atkins	Ph: 919-580-0000
	Kinston
	Kinston Medical Specialists
		Peter R. Watson	Ph: 252-559-2200
	Monroe
	Edwards Cancer Center at Union Regional Medical Center
		John F. Mahoney	Ph: 704-355-2884
	Rutherfordton
	Rutherford Hospital
		Charles E Bowers	Ph: 800-486-5941
	Shelby
	Cleveland Regional Medical Center
		John F. Mahoney	Ph: 704-355-2884
	Statesville
	Iredell Memorial Hospital
		Ruby A. Grimm	Ph: 704-873-5661
	Winston-Salem
	Forsyth Regional Cancer Center at Forsyth Medical Center
		Judith Owen Hopkins	Ph: 336-277-8887
	Wake Forest University Comprehensive Cancer Center
		Kethandapatti C Balaji	Ph: 336-713-6771
			Email: laura.lefko@umassmed.edu
Ohio
	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
	Lima
	St. Rita's Medical Center
		Henry Gerad	Ph: 419-226-9617
Oklahoma
	Oklahoma City
	Oklahoma University Cancer Institute
		Carla Kurkjian	Ph: 405-271-4272
			Email: julie-traylor@ouhsc.edu
Oregon
	Coos Bay
	Bay Area Hospital
		Bret A. Cook	Ph: 541-269-8392
			Email: cherie.cox@bayareahospital.org
	Portland
	Kaiser Permanente Health Care - Portland
		Nagendra Tirumali	Ph: 503-335-2400
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
	Pittsburgh
	UPMC Cancer Centers
		Jodi K Maranchie	Ph: 412-621-2334
South Carolina
	Anderson
	AnMed Cancer Center
		Charles E Bowers	Ph: 800-486-5941
	Charleston
	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
	Spartanburg
	CCOP - Upstate Carolina
		Charles E Bowers	Ph: 800-486-5941
	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
		Charles E Bowers	Ph: 800-486-5941
Tennessee
	Kingsport
	Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
		Asheesh Shipstone	Ph: 423-578-8538
	Nashville
	MBCCOP - Meharry Medical College - Nashville
		Steven N. Wolff	Ph: 615-327-5724
			Email: jmurray@mmc.edu
Vermont
	Berlin
	Mountainview Medical
		Steven Ades	Ph: 802-656-8990
	Burlington
	Vermont Cancer Center at University of Vermont
		Steven Ades	Ph: 802-656-8990
Virginia
	Lynchburg
	Lynchburg Hematology-Oncology Clinic
		John Leach MacNeill	Ph: 434-200-5925
	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: 253-403-2394
	Centralia
	Providence Centralia Hospital
		Yoshio Inoue	Ph: 253-403-2394
	Federal Way
	St. Francis Hospital
		Yoshio Inoue	Ph: 253-403-2394
	Kirkland
	Cascade Cancer Center at Evergreen Hospital Medical Center
		Craig R. Nichols	Ph: 503-215-6412
		Craig R. Nichols	Ph: 503-215-6412
	Olympia
	Providence St. Peter Hospital Regional Cancer Center
		Yoshio Inoue	Ph: 253-403-2394
	Puyallup
	Good Samaritan Cancer Center
		Yoshio Inoue	Ph: 253-403-2394
	Seattle
	CCOP - Virginia Mason Research Center
		Craig R. Nichols	Ph: 503-215-6412
	Pacific Medical Center
		Craig R. Nichols	Ph: 503-215-6412
	Virginia Mason Medical Center
		Craig R. Nichols	Ph: 503-215-6412
	Spokane
	Rockwood Clinic Cancer Treatment Center
		Kirk A. Lund	Ph: 509-755-5800
	Tacoma
	Allenmore Hospital
		Yoshio Inoue	Ph: 253-403-2394
	CCOP - Northwest
		Yoshio Inoue	Ph: 253-403-2394
	Franciscan Cancer Center at St. Joseph Medical Center
		Yoshio Inoue	Ph: 253-403-2394
	Madigan Army Medical Center - Tacoma
		Anthony J Fadell	Ph: 253-968-0129
			Email: mamcdci@amedd.army.mil
	MultiCare Regional Cancer Center at Tacoma General Hospital
		Yoshio Inoue	Ph: 253-403-2394
	St. Clare Hospital
		Yoshio Inoue	Ph: 253-403-2394
West Virginia
	Charleston
	West Virginia University Medical School - Charleston
		Steven J. Jubelirer	Ph: 304-388-9944
	Huntington
	Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
		Maria-Rosalia B. Tria Tirona	Ph: 304-399-6617
Wisconsin
	La Crosse
	Gundersen Lutheran Center for Cancer and Blood
		Kurt Oettel	Ph: 608-775-2385
			Email: cancerctr@gundluth.org
	New Richmond
	Cancer Center of Western Wisconsin
		Joseph W Leach	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
Wyoming
	Casper
	Rocky Mountain Oncology
		Benjamin Thomas Marchello	Ph: 800-648-6274
	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
Quebec
	Montreal
	Hopital Notre-Dame du CHUM
		Fred Saad	Ph: 514-890-8000ext23611
			Email: sylvie.beaudoin.chum@ssss.gouv.qc.ca

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00430183
Information obtained from ClinicalTrials.gov on February 20, 2013

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