Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Bevacizumab, Sorafenib, and Temsirolimus in Treating Patients With Metastatic Kidney Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	18 and over	NCI	ECOG-E2804 E2804, NCT00378703

Special Category: CTSU trial

Objectives

Primary

1. Compare progression-free survival (PFS) of patients with advanced renal cell carcinoma treated with different combinations of bevacizumab, sorafenib tosylate, and temsirolimus vs bevacizumab alone.

Secondary

1. Assess the significance of changes in tumor size over early time points as a predictor of PFS of patients treated with these regimens.
2. Compare the number and percentage of patients with stable disease at 6 months of therapy (failure to progress).
3. Compare the safety of these regimens in these patients.
4. Compare overall survival of patients treated with these regimens.
5. Compare the objective response rate in patients treated with these regimens.
6. Assess pathology, angiogenesis histology, and activation status of MAP kinase and VEGFR2 pathways and relate to clinical outcome.

Entry Criteria

Disease Characteristics:

• Histologically confirmed clear cell renal cell carcinoma
  • Primary or metastatic lesion
  • Less than 25% of any other histology (papillary, chromophobe, or oncocytic)



• Sufficient pathology material available for diagnostic review
  • Core-needle biopsy allowed
  • No fine-needle aspirations as only source for diagnosis



• Measurable metastatic disease



• Not curable by standard radiotherapy or surgery



• Prior nephrectomy required, with the following exceptions:
  • Primary tumor ≤ 5 cm
  • Extensive liver metastases (> 30% of liver parenchymal) or multiple (> 5) bone metastases



• No history or clinical evidence of CNS disease, including primary brain tumor or brain metastases

Prior/Concurrent Therapy:

• See Disease Characteristics
• No more than 1 prior regimen containing vaccine- or cytokine-based immunotherapy for advanced disease
• No prior antiangiogenic therapy including, but not limited to, sunitinib malate, ZD6474, or VEGF Trap
• No prior bevacizumab, mTOR inhibitors (including, but not limited to, temsirolimus), or sorafenib tosylate
• Prior thalidomide or interferon alfa allowed as adjuvant therapy or for stage IV disease
• More than 4 weeks since prior immunotherapy
• More than 2 weeks since prior radiotherapy and recovered
• More than 4 weeks since prior major surgery or open biopsy
• No concurrent major surgery
• No concurrent or recent full-dose anticoagulants or thrombolytic agents (unless required to maintain patency of pre-existing or permanent indwelling IV catheters)
• No concurrent cytochrome P450 enzyme-inducing drugs including any of the following:
  • Phenytoin
  • Carbamazepine
  • Phenobarbital
  • Rifampin
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent anticancer therapies or investigational agents
• No concurrent prophylactic hematopoietic colony-stimulating factors

Patient Characteristics:

• ECOG performance status 0-1
• Life expectancy > 3 months
• WBC ≥ 3,000/mm³
• Absolute granulocyte count ≥ 1,200/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9.0 g/dL (transfusions allowed)
• Creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 55 mL/min
• Bilirubin ≤ 1.5 times ULN
• AST/ALT ≤ 2.5 times ULN (5.0 times ULN in the presence of liver metastases)
• INR ≤ 1.5 and aPTT normal
• Fasting cholesterol < 350 mg/dL
• Fasting triglycerides < 400 mg/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 6 months after completion of study treatment
• No seizures not controlled with standard medical therapy
• No stroke within the past 12 months
• No other malignancies within the past 5 years except basal cell skin cancer, squamous cell skin cancer, carcinoma in situ of the cervix, or ductal or lobular carcinoma in situ of the breast
• No history of allergic reactions attributed to Chinese hamster ovary cell products, other recombinant human antibodies, or compounds of similar chemical or biologic composition to sorafenib tosylate, temsirolimus, or bevacizumab
• No history of bleeding diathesis or coagulopathy
• No condition that impairs ability to swallow pills
• No significant traumatic injury within the past 28 days
• No clinically significant cardiovascular disease, including any of the following:
  • Uncontrolled hypertension
    • Blood pressure must be ≤ 150/100 mm Hg on a stable antihypertensive regimen
  • Myocardial infarction or unstable angina within the past 6 months
  • New York Heart Association class II-IV congestive heart failure
  • Serious cardiac arrhythmia requiring medication
  • Unstable angina pectoris
  • Peripheral vascular disease ≥ grade 2
• No serious, nonhealing wound, ulcer, or bone fracture
• No significant proteinuria
  • If urine protein:creatinine ratio > 0.5, 24-hour urine protein must be < 1,000 mg
• No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parental antibiotics on day 0 or psychiatric illness or social situations that would preclude compliance with study requirements

Expected Enrollment

A total of 360 patients will be accrued for this study.

Outcomes

Progression-free survival

Safety
Overall survival as assessed by the Kaplan-Meier method
Objective response rate
Number and percentage of patients with stable disease at 6 months

Outline

This is a randomized, multicenter study. Patients are stratified according to prior cytokine or vaccine therapy (no vs yes) and Motzer risk category (low vs intermediate vs high). Patients are randomized to 1 of 4 treatment arms.

• Arm A: Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15.



• Arm B: Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in arm A.



• Arm C: Patients receive bevacizumab as in arm A and oral sorafenib tosylate twice daily on days 1-28.



• Arm D: Patients receive temsirolimus as in arm B and sorafenib tosylate as in arm C.

In all arms treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Keith Flaherty, MD, Protocol chair		Ph: 215-662-7402
David McDermott, MD, Protocol co-chair		Ph: 617-667-9920

U.S.A.
Alabama
	Birmingham
	Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
		Clinical Trials Office - Lurleen Wallace Comprehensive Cancer	Ph:  205-934-0309
Arizona
	Scottsdale
	Mayo Clinic Scottsdale
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
Arkansas
	Ft. Smith
	Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
		John Wells, MD	Ph:  479-484-4700
California
	Glendale
	Glendale Memorial Hospital Comprehensive Cancer Center
		Clinical Trials Office - Glendale Memorial Hospital Comprehensive Cancer Center	Ph:  818-409-7653
	Greenbrae
	California Cancer Care, Incorporated - Greenbrae
		Peter Eisenberg, MD	Ph:  415-925-5000
	La Jolla
	Rebecca and John Moores UCSD Cancer Center
		Clinical Trials Office - Rebecca and John Moores UCSD Cancer Center	Ph:  858-822-5354
			Email: cancercto@ucsd.edu
	Mountain View
	Camino Medical Group - Treatment Center
		Peter Yu, MD	Ph:  408-524-5814
	Palo Alto
	Palo Alto Medical Foundation
		Peter Yu, MD	Ph:  408-524-5814
Connecticut
	Hartford
	Helen and Harry Gray Cancer Center at Hartford Hospital
		Clinical Trials Office - Helen and Harry Gray Cancer Center	Ph:  860-545-5363
Delaware
	Lewes
	Tunnell Cancer Center at Beebe Medical Center
		Clinical Trials Office - Tunnell Cancer Center	Ph:  302-645-3171
	Newark
	CCOP - Christiana Care Health Services
		Clinical Trial Office - CCOP - Christiana Care Health Services	Ph:  302-733-6227
Florida
	Boca Raton
	Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
		Clinical Trials Office - Eugene M. and Christine E. Lynn Cancer Institute	Ph:  561-955-4800
	Jacksonville
	Mayo Clinic - Jacksonville
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
	Orlando
	M.D. Anderson Cancer Center at Orlando
		Julio Hajdenberg, MD	Ph:  321-841-7219
Georgia
	Macon
	Medical Center of Central Georgia
		Frederick Schnell, MD, FACP	Ph:  478-743-7068
Illinois
	Alton
	Saint Anthony's Hospital at Saint Anthony's Health Center
		Bethany Sleckman, MD	Ph:  314-251-7057
	Bloomington
	St. Joseph Medical Center
		John Kugler, MD	Ph:  309-243-3605
	Canton
	Graham Hospital
		John Kugler, MD	Ph:  309-243-3605
	Carthage
	Memorial Hospital
		John Kugler, MD	Ph:  309-243-3605
	Chicago
	Hematology and Oncology Associates
		Clinical Trails Office - Hematology and Oncology Associates	Ph:  312-695-1301
	Robert H. Lurie Comprehensive Cancer Center at Northwestern University
		Clinical Trials Office - Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Ph:  312-695-1301
			Email: cancer@northwestern.edu
	University of Illinois Cancer Center
		Clinical Trial Office - University of Illinois Cancer Center	Ph:  312-355-3046
	Elgin
	Sherman Hospital
		James Wade, MD	Ph:  217-876-6617
	Eureka
	Eureka Community Hospital
		John Kugler, MD	Ph:  309-243-3605
	Evanston
	Evanston Northwestern Healthcare - Evanston Hospital
		Clinical Trials Office - Evanston Northwestern Healthcare - Evanston Hospital	Ph:  847-570-1381
	Galesburg
	Galesburg Clinic, PC
		John Kugler, MD	Ph:  309-243-3605
	Galesburg Cottage Hospital
		John Kugler, MD	Ph:  309-243-3605
	Harvey
	Ingalls Cancer Care Center at Ingalls Memorial Hospital
		Clinical Trials Office - Ingalls Cancer Care Center at Ingalls Memorial Hospital	Ph:  708-915-6747
	Havana
	Mason District Hospital
		John Kugler, MD	Ph:  309-243-3605
	Hopedale
	Hopedale Medical Complex
		John Kugler, MD	Ph:  309-243-3605
	Joliet
	Midwest Center for Hematology/Oncology
		Timothy Kuzel, MD	Ph:  312-695-6180
	La Grange
	La Grange Memorial Hospital
		Clinical Trials Office - La Grange Memorial Hospital	Ph:  630-856-7526
	Libertyville
	North Shore Oncology and Hematology Associates, Limited - Libertyville
		Timothy Kuzel, MD	Ph:  312-695-6180
	Macomb
	McDonough District Hospital
		John Kugler, MD	Ph:  309-243-3605
	Mt. Vernon
	Good Samaritan Regional Health Center
		Bethany Sleckman, MD	Ph:  314-251-7057
	Naperville
	La Grange Oncology Associates - Geneva
		Timothy Kuzel, MD	Ph:  312-695-6180
	Niles
	Cancer Care and Hematology Specialists of Chicagoland - Niles
		Timothy Kuzel, MD	Ph:  312-695-6180
	Normal
	BroMenn Regional Medical Center
		John Kugler, MD	Ph:  309-243-3605
	Community Cancer Center
		John Kugler, MD	Ph:  309-243-3605
	Ottawa
	Community Hospital of Ottawa
		John Kugler, MD	Ph:  309-243-3605
	Oncology Hematology Associates of Central Illinois, PC - Ottawa
		John Kugler, MD	Ph:  309-243-3605
	Pekin
	Cancer Treatment Center at Pekin Hospital
		John Kugler, MD	Ph:  309-243-3605
	Peoria
	CCOP - Illinois Oncology Research Association
		John Kugler, MD	Ph:  309-243-3605
	Methodist Medical Center of Illinois
		Clinical Trials Office - Methodist Medical Center of Illinois	Ph:  309-243-3000
	Oncology Hematology Associates of Central Illinois, PC - Peoria
		John Kugler, MD	Ph:  309-243-3605
	OSF St. Francis Medical Center
		John Kugler, MD	Ph:  309-243-3605
	Proctor Hospital
		John Kugler, MD	Ph:  309-243-3605
	Peru
	Illinois Valley Community Hospital
		John Kugler, MD	Ph:  309-243-3605
	Princeton
	Perry Memorial Hospital
		John Kugler, MD	Ph:  309-243-3605
	Rockford
	Swedish-American Regional Cancer Center
		Clinical Trials Office - Swedish-American Regional Cancer Center	Ph:  815-489-4413
	Skokie
	Hematology Oncology Associates - Skokie
		Timothy Kuzel, MD	Ph:  312-695-6180
	Spring Valley
	St. Margaret's Hospital
		John Kugler, MD	Ph:  309-243-3605
Indiana
	Beech Grove
	St. Francis Hospital and Health Centers - Beech Grove Campus
		Howard Gross, MD	Ph:  937-832-1093
	Elkhart
	Elkhart General Hospital
		Bilal Ansari, MD	Ph:  269-983-8260
	Fort Wayne
	Fort Wayne Medical Oncology and Hematology
		Sreenivasa Nattam, MD	Ph:  260-484-8830
	Indianapolis
	Indiana University Melvin and Bren Simon Cancer Center
		Clinical Trials Office - Indiana University Cancer Center	Ph:  317-274-2552
	Veterans Affairs Medical Center - Indianapolis
		Theodore Logan, MD	Ph:  317-278-7576
	William N. Wishard Memorial Hospital
		Theodore Logan, MD	Ph:  317-278-7576
	Kokomo
	Howard Community Hospital
		Bilal Ansari, MD	Ph:  269-983-8260
	La Porte
	Center for Cancer Therapy at LaPorte Hospital and Health Services
		Bilal Ansari, MD	Ph:  269-983-8260
	Lafayette
	Horizon Oncology Center
		Wael Harb	Ph:  765-446-5111 866-877-1077
	Richmond
	Reid Hospital & Health Care Services
		Howard Gross, MD	Ph:  937-832-1093
	South Bend
	CCOP - Northern Indiana CR Consortium
		Bilal Ansari, MD	Ph:  269-983-8260
	Memorial Hospital of South Bend
		Clinical Trials Office - Memorial Hospital of South Bend	Ph:  800-284-7370
	Saint Joseph Regional Medical Center
		Bilal Ansari, MD	Ph:  269-983-8260
	South Bend Clinic
		Bilal Ansari, MD	Ph:  269-983-8260
Iowa
	Ames
	McFarland Clinic, PC
		Clinical Trials Office - McFarland Clinic, PC	Ph:  515-239-2621
	Cedar Rapids
	Cedar Rapids Oncology Associates
		Clinical Trials Office - Cedar Rapids Oncology Associates	Ph:  319-363-2690
	Mercy Regional Cancer Center at Mercy Medical Center
		Martin Wiesenfeld, MD	Ph:  319-363-8303
	Davenport
	Genesis Medical Center - West Campus
		George Kovach, MD	Ph:  563-421-1960
	Genesis Regional Cancer Center at Genesis Medical Center
		George Kovach, MD	Ph:  563-421-1960
	Des Moines
	CCOP - Iowa Oncology Research Association
		Roscoe Morton, MD, FACP	Ph:  515-282-2921
	John Stoddard Cancer Center at Iowa Lutheran Hospital
		Clinical Trials Office - John Stoddard Cancer Center at Iowa Lutheran Hospital	Ph:  515-241-8704
	John Stoddard Cancer Center at Iowa Methodist Medical Center
		Clinical Trials Office - John Stoddard Cancer Center at Iowa Methodist Medical Center	Ph:  515-241-6727
	Medical Oncology and Hematology Associates at John Stoddard Cancer Center
		Roscoe Morton, MD, FACP	Ph:  515-282-2921
	Medical Oncology and Hematology Associates at Mercy Cancer Center
		Roscoe Morton, MD, FACP	Ph:  515-282-2921
	Mercy Cancer Center at Mercy Medical Center - Des Moines
		Roscoe Morton, MD, FACP	Ph:  515-282-2921
	Mercy Capitol Hospital
		Roscoe Morton, MD, FACP	Ph:  515-282-2921
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Cancer Information Service	Ph:  800-237-1225
	Mason City
	Mercy Cancer Center at Mercy Medical Center - North Iowa
		Clinical Trials Office - Mercy Cancer Center at Mercy Medical Center - North Iowa	Ph:  641-422-6304
	Ottumwa
	McCreery Cancer Center at Ottumwa Regional
		Roscoe Morton, MD, FACP	Ph:  515-282-2921
Kansas
	Anthony
	Hospital District Sixth of Harper County
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Chanute
	Cancer Center of Kansas, PA - Chanute
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Dodge City
	Cancer Center of Kansas, PA - Dodge City
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	El Dorado
	Cancer Center of Kansas, PA - El Dorado
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Fort Scott
	Cancer Center of Kansas - Fort Scott
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Independence
	Cancer Center of Kansas-Independence
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Kingman
	Cancer Center of Kansas, PA - Kingman
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Lawrence
	Lawrence Memorial Hospital
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Liberal
	Southwest Medical Center
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Newton
	Cancer Center of Kansas, PA - Newton
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Overland Park
	Menorah Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Parsons
	Cancer Center of Kansas, PA - Parsons
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Pratt
	Cancer Center of Kansas, PA - Pratt
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Salina
	Cancer Center of Kansas, PA - Salina
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Shawnee Mission
	Shawnee Mission Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Topeka
	Cotton-O'Neil Cancer Center
		Clinical Trials Office - Cotton-O'Neil Cancer Center	Ph:  785-270-4963
	Wellington
	Cancer Center of Kansas, PA - Wellington
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Wichita
	Associates in Womens Health, PA - North Review
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Cancer Center of Kansas, PA - Wichita
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Cancer Center of Kansas, PA - Medical Arts Tower
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	CCOP - Wichita
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Via Christi Cancer Center at Via Christi Regional Medical Center
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Winfield
	Cancer Center of Kansas, PA - Winfield
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
Maine
	Bangor
	CancerCare of Maine at Eastern Maine Medical Center
		Clinical Trials Office - CancerCare of Maine	Ph:  207-973-4274
Maryland
	Baltimore
	Greater Baltimore Medical Center Cancer Center
		Clinical Trials Office - Greater Baltimore Medical Center Cancer Center	Ph:  443-849-3706
	Elkton MD
	Union Hospital Cancer Program at Union Hospital
		Gregory Masters, MD	Ph:  302-366-1200
Michigan
	Adrian
	Hickman Cancer Center at Bixby Medical Center
		Clinical Trials Office - Hickman Cancer Center at Bixby Medical Center	Ph:  517-265-0116
	Battle Creek
	Battle Creek Health System Cancer Care Center
		Marianne Lange, MD	Ph:  616-977-6243
	Big Rapids
	Mecosta County Medical Center
		Marianne Lange, MD	Ph:  616-977-6243
	Grand Rapids
	Butterworth Hospital at Spectrum Health
		Marianne Lange, MD	Ph:  616-977-6243
	CCOP - Grand Rapids
		Marianne Lange, MD	Ph:  616-977-6243
	Lacks Cancer Center at Saint Mary's Health Care
		Marianne Lange, MD	Ph:  616-977-6243
	Lambertville
	Haematology-Oncology Associates of Ohio and Michigan, PC
		Paul Schaefer, MD	Ph:  419-479-5605
	Monroe
	Community Cancer Center of Monroe
		Paul Schaefer, MD	Ph:  419-479-5605
	Mercy Memorial Hospital - Monroe
		Paul Schaefer, MD	Ph:  419-479-5605
	Muskegon
	Mercy General Health Partners
		Marianne Lange, MD	Ph:  616-977-6243
	Southfield
	Providence Cancer Institute at Providence Hospital - Southfield Campus
		Kathleen Beekman, MD	Ph:  734-936-4991
	St. Joseph
	Lakeland Regional Cancer Care Center - St. Joseph
		Bilal Ansari, MD	Ph:  269-983-8260
	Traverse City
	Munson Medical Center
		Marianne Lange, MD	Ph:  616-977-6243
	Wyoming
	Metro Health Hospital
		Marianne Lange, MD	Ph:  616-977-6243
Minnesota
	Alexandria
		Donald Jurgens
	Fergus Falls
		Donald Jurgens
	Hutchinson
	Hutchinson Area Health Care
		Daniel Anderson	Ph:  320-234-5000 800-454-3903
	Maplewood
	HealthEast Cancer Care at St. John's Hospital
		Daniel Anderson	Ph:  651-232-7970
	Minneapolis
	Hennepin County Medical Center - Minneapolis
		Clinical Trials Office - Hennepin County Medical Center - Minneapolis	Ph:  612-873-5911
	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
		Clinical Trials Office - Virginia Piper Cancer Institute	Ph:  612-863-5654
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
	Saint Cloud
	CentraCare Clinic - River Campus
		Donald Jurgens	Ph:  320-252-5131
	Coborn Cancer Center
		Donald Jurgens	Ph:  320-229-4907 877-229-4907
	St. Paul
	Regions Hospital Cancer Care Center
		Clinical Trials Office - Regions Hospital Cancer Care Center	Ph:  651-254-1517
Mississippi
	Jackson
	University of Mississippi Cancer Clinic
		Robert Hamilton	Ph:  601-984-5590
	Pascagoula
	Regional Cancer Center at Singing River Hospital
		James Clarkson, MD	Ph:  228-374-6296
Missouri
	Cape Girardeau
	Saint Francis Medical Center
		Bethany Sleckman, MD	Ph:  314-251-7057
	Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
		Bethany Sleckman, MD	Ph:  314-251-7057
	Independence
	Independence Regional Health Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Joplin
	St. John's Regional Medical Center
		Clinical Trials Office - St. John's Regional Medical Center	Ph:  417-625-2488 ext. 2949
	Kansas City
	CCOP - Kansas City
		Rakesh Gaur, MD	Ph:  816-823-0555
	North Kansas City Hospital
		Rakesh Gaur, MD	Ph:  816-823-0555
	Parvin Radiation Oncology
		Rakesh Gaur, MD	Ph:  816-823-0555
	Research Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Saint Luke's Cancer Institute at Saint Luke's Hospital
		Rakesh Gaur, MD	Ph:  816-823-0555
	St. Joseph Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Truman Medical Center - Hospital Hill
		Rakesh Gaur, MD	Ph:  816-823-0555
	Saint Joseph
	Heartland Regional Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Saint Louis
	CCOP - St. Louis-Cape Girardeau
		Bethany Sleckman, MD	Ph:  314-251-7057
	David C. Pratt Cancer Center at St. John's Mercy
		Clinical Trials Office - David C. Pratt Cancer Center at St. John's Mercy	Ph:  314-251-6770
	Midwest Hematology Oncology Group, Incorporated
		Bethany Sleckman, MD	Ph:  314-251-7057
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Joel Picus, MD	Ph:  314-362-5737
Montana
	Billings
	Billings Clinic - Downtown
		Clinical Trials Office - Billings Clinic - Downtown	Ph:  800-996-2663
			Email: research@billingsclinic.org
	CCOP - Montana Cancer Consortium
		Benjamin Marchello, MD	Ph:  406-238-6290
	Hematology-Oncology Centers of the Northern Rockies - Billings
		Benjamin Marchello, MD	Ph:  406-238-6290
	Northern Rockies Radiation Oncology Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	St. Vincent Healthcare Cancer Care Services
		Benjamin Marchello, MD	Ph:  406-238-6290
	Butte
	St. James Healthcare Cancer Care
		Benjamin Marchello, MD	Ph:  406-238-6290
	Great Falls
		Benjamin Marchello, MD	Ph:  406-238-6290
	Great Falls Clinic - Main Facility
		Benjamin Marchello, MD	Ph:  406-238-6290
	Sletten Cancer Institute at Benefis Healthcare
		Grant Harrer, MD, FACP, CCTI	Ph:  406-731-8100
	Havre
	Northern Montana Hospital
		Benjamin Marchello, MD	Ph:  406-238-6290
	Kalispell
	Glacier Oncology, PLLC
		Benjamin Marchello, MD	Ph:  406-238-6290
	Kalispell Medical Oncology at KRMC
		Benjamin Marchello, MD	Ph:  406-238-6290
	Kalispell Regional Medical Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	Missoula
	Community Medical Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	Guardian Oncology and Center for Wellness
		Benjamin Marchello, MD	Ph:  406-238-6290
	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
		Clinical Trials Office - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Ph:  406-329-7029
	Montana Cancer Specialists at Montana Cancer Center
		Clinical Trials Office - Montana Cancer Specialists at Montana Cancer Center	Ph:  406-238-6962
Nebraska
	Kearney
	Good Samaritan Cancer Center at Good Samaritan Hospital
		Clinical Trials Office - Good Samaritan Cancer Center at Good Samaritan Hospital	Ph:  308-865-7963
New Jersey
	Marlton
	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
		Clinical Trials Office - Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton	Ph:  888-847-8823
	Morristown
	Carol G. Simon Cancer Center at Morristown Memorial Hospital
		Stacey Leibowitz	Ph:  973-971-6100 800-247-9580
	Summit
	Overlook Hospital
		Stacey Leibowitz	Ph:  908-522-2000
	Vineland
	Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
		Clinical Trials Office - Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare	Ph:  856-641-7933
	Voorhees
	Cancer Institute of New Jersey at Cooper - Voorhees
		Clinical Trials Office - Cancer Institute of New Jersey at Cooper University Hospital - Voorhees	Ph:  856-325-6757
	Fox Chase Virtua Health Cancer Program at Virtua West Jersey
		Michael Entmacher, MD	Ph:  609-702-1900
New York
	Bronx
	Our Lady of Mercy Medical Center Comprehensive Cancer Center
		Peter Wiernik, MD	Ph:  718-304-7200
	Buffalo
	Roswell Park Cancer Institute
		Clinical Trials Office - Roswell Park Cancer Institute	Ph:  877-275-7724
	Cooperstown
	Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital
		Eric Bravin, MD	Ph:  607-547-3336
	East Syracuse
	CCOP - Hematology-Oncology Associates of Central New York
		Jeffrey Kirshner, MD	Ph:  315-472-7504
	Manhasset
	CCOP - North Shore University Hospital
		Rajasree Roy	Ph:  516-734-8954
	Don Monti Comprehensive Cancer Center at North Shore University Hospital
		Clinical Trials Office - Don Monti Comprehensive Cancer Center at North Shore University Hospital	Ph:  516-734-8900
	New Hyde Park
	Long Island Jewish Medical Center
		Rajasree Roy	Ph:  718-470-7000 800-371-7111
	Rochester
	James P. Wilmot Cancer Center at University of Rochester Medical Center
		Richard Fisher, MD	Ph:  585-275-0842
North Carolina
	Asheville
	Mission Hospitals - Memorial Campus
		Clinical Trials Office - Mission Hospitals - Memorial Campus	Ph:  828-213-4150
	Charlotte
	Presbyterian Cancer Center at Presbyterian Hospital
		Clinical Trials Office - Presbyterian Cancer Center at Presbyterian Hospital	Ph:  704-384-5369
	Goldsboro
	Wayne Memorial Hospital, Incorporated
		James Atkins, MD	Ph:  919-580-0000
	Kinston
	Kinston Medical Specialists
		Peter Watson, MD	Ph:  252-559-2200ext.201
	Pinehurst
	FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
		Clinical Trials Office - FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center	Ph:  910-715-2200
	Winston-Salem
	Wake Forest University Comprehensive Cancer Center
		Clinical Trials Office - Wake Forest University Comprehensive Cancer Center	Ph:  336-713-6771
North Dakota
	Bismarck
	Bismarck Cancer Center
		Edward Wos, DO	Ph:  701-323-5741
	Medcenter One Hospital Cancer Care Center
		Edward Wos, DO	Ph:  701-323-5741
	Mid Dakota Clinic, PC
		Clinical Trials Office - Mid Dakota Clinic, PC	Ph:  701-530-6950
	St. Alexius Medical Center Cancer Center
		Clinical Trials Office - St. Alexius Medical Center Cancer Center	Ph:  701-530-6950
Ohio
	Akron
	McDowell Cancer Center at Akron General Medical Center
		Esther Rehmus, MD	Ph:  330-344-6505
	Bellefontaine
	Mary Rutan Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Bowling Green
	Wood County Oncology Center
		Paul Schaefer, MD	Ph:  419-479-5605
	Canton
	Aultman Cancer Center at Aultman Hospital
		Clinical Trials Office - Aultman Cancer Center at Aultman Hospital	Ph:  330-363-6891
	Mercy Cancer Center at Mercy Medical Center
		Mitchell Haut, MD	Ph:  330-453-9993
	Chillicothe
	Adena Regional Medical Center
		Clinical Trials Office - Adena Regional Medical Center	Ph:  877-779-7585
	Cincinnati
	Christ Hospital Cancer Center
		Manish Bhandari	Ph:  513-585-2323
	Cleveland
	MetroHealth Cancer Care Center at MetroHealth Medical Center
		Bruce Averbook, MD, FACS	Ph:  216-778-4795
	Columbus
	CCOP - Columbus
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Doctors Hospital at Ohio Health
		Clinical Trials Office - Doctors Hospital at Ohio Health	Ph:  614-566-3275
	Grant Medical Center Cancer Care
		Clinical Trials Office - Grant Medical Center Cancer Care	Ph:  614-566-4475
	Mount Carmel Health - West Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Riverside Methodist Hospital Cancer Care
		Clinical Trials Office - Riverside Methodist Hospital Cancer Care	Ph:  614-566-4475
	Dayton
	CCOP - Dayton
		Howard Gross, MD	Ph:  937-832-1093
	Good Samaritan Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Grandview Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Samaritan North Cancer Care Center
		Howard Gross, MD	Ph:  937-832-1093
	Veterans Affairs Medical Center - Dayton
		Howard Gross, MD	Ph:  937-832-1093
	Delaware
	Grady Memorial Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Elyria
	Hematology Oncology Center
		Paul Schaefer, MD	Ph:  419-479-5605
	Findlay
	Blanchard Valley Medical Associates
		Howard Gross, MD	Ph:  937-832-1093
	Franklin
	Middletown Regional Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Greenville
	Wayne Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Kettering
	Charles F. Kettering Memorial Hospital
		Clinical Trials Office - Charles F. Kettering Memorial Hospital	Ph:  937-298-3399 ext. 57556
	Lancaster
	Fairfield Medical Center
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Lima
	Lima Memorial Hospital
		Paul Schaefer, MD	Ph:  419-479-5605
	Marietta
	Strecker Cancer Center at Marietta Memorial Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Maumee
	Northwest Ohio Oncology Center
		Paul Schaefer, MD	Ph:  419-479-5605
		Paul Schaefer, MD	Ph:  419-479-5605
	St. Luke's Hospital
		Paul Schaefer, MD	Ph:  419-479-5605
	Newark
	Licking Memorial Cancer Care Program at Licking Memorial Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Oregon
	St. Charles Mercy Hospital
		Paul Schaefer, MD	Ph:  419-479-5605
	Toledo Clinic - Oregon
		Paul Schaefer, MD	Ph:  419-479-5605
	Sandusky
	North Coast Cancer Care, Incorporated
		Paul Schaefer, MD	Ph:  419-479-5605
	Springfield
	Community Hospital of Springfield and Clark County
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Mercy Medical Center
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Sylvania
	Flower Hospital Cancer Center
		Clinical Trials Office - Flower Hospital Cancer Center	Ph:  419-824-1842
	Tiffin
	Mercy Hospital of Tiffin
		Paul Schaefer, MD	Ph:  419-479-5605
	Toledo
	CCOP - Toledo Community Hospital
		Paul Schaefer, MD	Ph:  419-479-5605
	Medical University of Ohio Cancer Center
		Clinical Trials Office - Medical University of Ohio Cancer Center	Ph:  419-383-6583
	St. Anne Mercy Hospital
		Paul Schaefer, MD	Ph:  419-479-5605
	St. Vincent Mercy Medical Center
		Paul Schaefer, MD	Ph:  419-479-5605
	Toledo Clinic, Incorporated - Main Clinic
		Paul Schaefer, MD	Ph:  419-479-5605
	Toledo Hospital
		Clinical Trials Office - Toledo Hospital	Ph:  419-824-1842
	Troy
	UVMC Cancer Care Center at Upper Valley Medical Center
		Clinical Trials Office - UVMC Cancer Care Center at Upper Valley Medical Center	Ph:  937-440-4842
	Wauseon
	Fulton County Health Center
		Clinical Trials Office - Fulton County Health Center	Ph:  419-330-2708
	Westerville
	Mount Carmel St. Ann's Cancer Center
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Wilmington
	Clinton Memorial Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Xenia
	Ruth G. McMillan Cancer Center at Greene Memorial Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Zanesville
	Genesis - Good Samaritan Hospital
		Clinical Trials Office - Genesis - Good Samaritan Hospital	Ph:  740-454-5232
Oregon
	Coos Bay
	Bay Area Hospital
		Bret Cook, MD	Ph:  541-267-5151
Pennsylvania
	Allentown
	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
		Eliot Friedman, MD	Ph:  610-402-0512
	Bethlehem
	St. Luke's Cancer Network at St. Luke's Hospital
		Sanjiv Agarwala, MD	Ph:  610-954-2145
	Danville
	Geisinger Cancer Institute at Geisinger Health
		Clinical Trials Office - Geisinger Cancer Institute	Ph:  570-271-5251
	Hazleton
	Geisinger Hazleton Cancer Center
		Albert Bernath, MD	Ph:  570-214-9290
	Lancaster
	Lancaster General Hospital
		Randall Oyer	Ph:  717-544-5511
	Lemoyne
	Central Pennsylvania Hematology and Medical Oncology Associates, PC
		John Conroy, DO, FACP, FACOI	Ph:  717-737-5767
	Media
	Riddle Memorial Hospital Cancer Center
		Jongming Li	Ph:  610-627-4480
	Philadelphia
	Abramson Cancer Center of the University of Pennsylvania
		Clinical Trials Office - Abramson Cancer Center of the University of Pennsylvania	Ph:  800-474-9892
	Albert Einstein Cancer Center
		William Tester, MD	Ph:  215-456-8295
	Fox Chase Cancer Center - Philadelphia
		Clinical Trials Office - Fox Chase Cancer Center - Philadelphia	Ph:  215-728-4790
	Joan Karnell Cancer Center at Pennsylvania Hospital
		Bernard Mason, MD	Ph:  215-829-6088
	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
		Clinical Trials Office - Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Ph:  215-955-6084
	Reading
	McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
		Clinical Trials Office - McGlinn Family Regional Cancer Center	Ph:  610-988-9323
	Scranton
	Hematology and Oncology Associates of Northeastern Pennsylvania
		Martin Hyzinski, MD	Ph:  570-558-3020
	Mercy Hospital Cancer Center - Scranton
		Martin Hyzinski, MD	Ph:  570-558-3020
	State College
	Geisinger Medical Group - Scenery Park
		Albert Bernath, MD	Ph:  570-214-9290
	Wilkes-Barre
	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
		Clinical Trials Office - Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Ph:  570-271-5251
South Dakota
	Rapid City
	Rapid City Regional Hospital
		Richard Tenglin	Ph:  605-719-2360
Tennessee
	Knoxville
	Thompson Cancer Survival Center
		Clinical Trials Office - Thompson Cancer Survival Center	Ph:  865-541-1812
	U.T. Medical Center Cancer Institute
		Clinical Trials Office - U.T. Medical Center Cancer Institute	Ph:  865-544-9773
	Memphis
	University of Tennessee Cancer Institute - Memphis
		Clinical Trials Office - University of Tennessee Cancer Institute	Ph:  901-448-3303
	Nashville
	Vanderbilt-Ingram Cancer Center
		Clinical Trials Office - Vanderbilt-Ingram Cancer Center	Ph:  1-800-811-8480;
Texas
	Houston
	Baylor University Medical Center - Houston
		Martha Mims	Ph:  713-798-8070
	Ben Taub General Hospital
		Martha Mims	Ph:  713-873-2000
	Methodist Hospital
		Martha Mims	Ph:  713-441-1010
	St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
		Martha Mims	Ph:  832-355-3490
	Veterans Affairs Medical Center - Houston
		Martha Mims	Ph:  713-794-7111 800-553-2278
Virginia
	Danville
	Danville Regional Medical Center
		Clinical Trials Office - Danville Regional Medical Center	Ph:  434-799-3753
	Fredericksburg
	Fredericksburg Oncology, Incorporated
		Paul Schaefer, MD	Ph:  419-479-5605
	Martinsville
	Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
		Arthur Sleeper, MD	Ph:  276-666-7200
West Virginia
	Charleston
	West Virginia University Health Sciences Center - Charleston
		Steven Jubelirer, MD	Ph:  304-388-8380
Wisconsin
	Appleton
	Fox Valley Hematology and Oncology - East Grant Street
		Timothy Goggins	Ph:  920-749-1171
	La Crosse
	Gundersen Lutheran Center for Cancer and Blood
		Clinical Trials Office - Gundersen Lutheran Cancer Center	Ph:  608-775-2385
			Email: cancerctr@gundluth.org
	Madison
	Dean Medical Center - Madison
		Charles Diggs, MD	Ph:  608-410-2746
	Marshfield
	Marshfield Clinic - Marshfield Center
		Clinical Trials Office - Marshfield Clinic - Marshfield Center	Ph:  800-782-1581 ext. 94457
	Milwaukee
	Froedtert Hospital and Medical College of Wisconsin
		Clinical Trials Office - Froedtert Hospital	Ph:  414-805-3666
	Medical College of Wisconsin Cancer Center
		Clinical Trials Office - Medical College of Wisconsin Cancer Center	Ph:  414-805-4380
	Wisconsin Rapids
	Riverview UW Cancer Center at Riverview Hospital
		Ron Kirschling, MD, FACP	Ph:  715-421-7442