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.

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



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



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



• Arm IV: Patients receive temsirolimus as in arm II and sorafenib tosylate as in arm III.

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: 215-662-8624
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
California
	Berkeley
	Alta Bates Summit Comprehensive Cancer Center
		Clinical Trials Office - Alta Bates Summit Comprehensive Cancer Center	Ph:  510-204-3428
	Burlingame
	Peninsula Medical Center
		David Irwin, MD	Ph:  510-204-2866
	Greenbrae
	California Cancer Care, Incorporated - Greenbrae
		Peter Eisenberg, MD	Ph:  415-925-5000
	Marin Cancer Institute at Marin General Hospital
		David Irwin, MD	Ph:  510-204-2866
	Sutter Health - Western Division Cancer Research Group
		David Irwin, MD	Ph:  510-204-2866
	Mountain View
	Camino Medical Group - Treatment Center
		Peter Yu, MD	Ph:  408-524-5085
	Palo Alto
	Palo Alto Medical Foundation
		Peter Yu, MD	Ph:  408-524-5085
	San Francisco
	California Pacific Medical Center - California Campus
		David Irwin, MD	Ph:  510-204-2866
	Vallejo
	Sutter Solano Medical Center
		David Irwin, MD	Ph:  510-204-2866
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
	Jacksonville
	Mayo Clinic - Jacksonville
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
Georgia
	Gainesville
	Northeast Georgia Medical Center
		Richard LoCicero, MD	Ph:  770-535-3553
Illinois
	Alton
	Saint Anthony's Hospital at Saint Anthony's Health Center
		Bethany Sleckman, MD	Ph:  314-251-6573
	Bloomington
	St. Joseph Medical Center
		John Kugler, MD	Ph:  309-243-3000
	Canton
	Graham Hospital
		John Kugler, MD	Ph:  309-243-3000
	Carthage
	Memorial Hospital
		John Kugler, MD	Ph:  309-243-3000
	Decatur
	Decatur Memorial Hospital Cancer Care Institute
		Clinical Trials Office - Decatur Memorial Hospital Cancer Care Institute	Ph:  217-876-6601
	Elgin
	Sherman Hospital
		James Wade, MD	Ph:  217-876-6600
	Eureka
	Eureka Community Hospital
		John Kugler, MD	Ph:  309-243-3000
	Galesburg
	Galesburg Clinic, PC
		John Kugler, MD	Ph:  309-243-3000
	Galesburg Cottage Hospital
		John Kugler, MD	Ph:  309-243-3000
	Havana
	Mason District Hospital
		John Kugler, MD	Ph:  309-243-3000
	Hopedale
	Hopedale Medical Complex
		John Kugler, MD	Ph:  309-243-3000
	La Grange
	La Grange Memorial Hospital
		Clinical Trials Office - La Grange Memorial Hospital	Ph:  630-856-7526
	Macomb
	McDonough District Hospital
		John Kugler, MD	Ph:  309-243-3000
	Moline
		Costas Constantinou, MD
		Costas Constantinou, MD	Ph:  916-734-2781
		Costas Constantinou, MD	Ph:  309-779-4265
		Costas Constantinou, MD	Ph:  309-779-5090
	Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
		Costas Constantinou, MD	Ph:  309-779-5092
	Mt. Vernon
	Good Samaritan Regional Health Center
		Bethany Sleckman, MD	Ph:  314-251-6573
	Normal
	BroMenn Regional Medical Center
		John Kugler, MD	Ph:  309-243-3000
	Community Cancer Center
		John Kugler, MD	Ph:  309-243-3000
	Ottawa
	Community Hospital of Ottawa
		John Kugler, MD	Ph:  309-243-3000
	Oncology Hematology Associates of Central Illinois, PC - Ottawa
		John Kugler, MD	Ph:  309-243-3000
	Pekin
	Cancer Treatment Center at Pekin Hospital
		John Kugler, MD	Ph:  309-243-3000
	Peoria
	CCOP - Illinois Oncology Research Association
		John Kugler, MD	Ph:  309-243-3000
	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:  309-243-3000
	OSF St. Francis Medical Center
		John Kugler, MD	Ph:  309-243-3000
	Proctor Hospital
		John Kugler, MD	Ph:  309-243-3000
	Peru
	Illinois Valley Community Hospital
		John Kugler, MD	Ph:  309-243-3000
	Princeton
	Perry Memorial Hospital
		John Kugler, MD	Ph:  309-243-3000
	Rockford
	Swedish-American Regional Cancer Center
		Clinical Trials Office - Swedish-American Regional Cancer Center	Ph:  815-489-4413
	Spring Valley
	St. Margaret's Hospital
		John Kugler, MD	Ph:  309-243-3000
	Springfield
	Regional Cancer Center at Memorial Medical Center
		Clinical Trials Office - Regional Cancer Center at Memorial Medical Center	Ph:  217-788-4233
Indiana
	Beech Grove
	St. Francis Hospital and Health Centers - Beech Grove Campus
		Howard Gross, MD	Ph:  317-787-3311
	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:  317-554-0000 888-878-6889
	William N. Wishard Memorial Hospital
		Theodore Logan, MD	Ph:  317-639-6671
	Kokomo
	Howard Community Hospital
		Bilal Ansari, MD	Ph:  574-237-1328
	La Porte
	Center for Cancer Therapy at LaPorte Hospital and Health Services
		Bilal Ansari, MD	Ph:  574-237-1328
	Richmond
	Reid Hospital & Health Care Services
		Howard Gross, MD	Ph:  765-983-3000
	South Bend
	CCOP - Northern Indiana CR Consortium
		Bilal Ansari, MD	Ph:  574-237-1328
	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:  574-237-1328
Iowa
	Bettendorf
		Costas Constantinou, MD	Ph:  563-421-1960
	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:  319-398-6011
	Des Moines
	CCOP - Iowa Oncology Research Association
		Roscoe Morton, MD, FACP	Ph:  515-244-7586
	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:  515-244-7586
	Medical Oncology and Hematology Associates at Mercy Cancer Center
		Roscoe Morton, MD, FACP	Ph:  515-244-7586
	Mercy Cancer Center at Mercy Medical Center - Des Moines
		Roscoe Morton, MD, FACP	Ph:  515-244-7586
	Mercy Capitol Hospital
		Roscoe Morton, MD, FACP	Ph:  515-244-7586
Kansas
	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
	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
	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
	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
	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
Maryland
	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:  616-966-8000
	Big Rapids
	Mecosta County Medical Center
		Marianne Lange, MD	Ph:  231-796-8691
	Grand Rapids
	Butterworth Hospital at Spectrum Health
		Marianne Lange, MD	Ph:  616-391-2799
	CCOP - Grand Rapids
		Marianne Lange, MD	Ph:  616-391-1230
	Lacks Cancer Center at Saint Mary's Health Care
		Marianne Lange, MD	Ph:  616-752-5222
	Lambertville
	Haematology-Oncology Associates of Ohio and Michigan, PC
		Paul Schaefer, MD	Ph:  419-843-6147
	Monroe
	Community Cancer Center of Monroe
		Paul Schaefer, MD	Ph:  419-843-6147
	Mercy Memorial Hospital - Monroe
		Paul Schaefer, MD	Ph:  419-843-6147
	Muskegon
	Hackley Hospital
		Marianne Lange, MD	Ph:  231-726-3511
	St. Joseph
	Lakeland Regional Cancer Care Center - St. Joseph
		Bilal Ansari, MD	Ph:  574-237-1328
	Traverse City
	Munson Medical Center
		Marianne Lange, MD	Ph:  231-935-6202
	Wyoming
	Metro Health Hospital
		Marianne Lange, MD	Ph:  616-252-7200
Minnesota
	Burnsville
	Fairview Ridges Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Coon Rapids
	Mercy and Unity Cancer Center at Mercy Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Edina
	Fairview Southdale Hospital
		Clinical Trials Office - Fairview Southdale Hospital	Ph:  612-625-3650
	Fridley
	Mercy and Unity Cancer Center at Unity Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Maplewood
	Minnesota Oncology Hematology, PA - Maplewood
		Patrick Flynn, MD	Ph:  612-863-8585
	Minneapolis
	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
		Clinical Trials Office - Virginia Piper Cancer Institute	Ph:  612-863-5654
	Robbinsdale
	Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
		Clinical Trials Office - Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center	Ph:  763-520-1893
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
	Saint Louis Park
	CCOP - Metro-Minnesota
		Patrick Flynn, MD	Ph:  612-863-8585
	Park Nicollet Cancer Center
		Patrick Flynn, MD	Ph:  612-863-8585
	Saint Paul
	United Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Waconia
	Ridgeview Medical Center
		Patrick Flynn, MD	Ph:  612-863-8585
	Woodbury
	Minnesota Oncology Hematology, PA - Woodbury
		Patrick Flynn, MD	Ph:  612-863-8585
Mississippi
	Pascagoula
	Regional Cancer Center at Singing River Hospital
		James Clarkson, MD	Ph:  228-809-5251
Missouri
	Cape Girardeau
	Saint Francis Medical Center
		Bethany Sleckman, MD	Ph:  314-251-6573
	Gape Girardeau
	Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
		Bethany Sleckman, MD	Ph:  314-251-6573
	Saint Louis
	CCOP - St. Louis-Cape Girardeau
		Bethany Sleckman, MD	Ph:  314-251-6573
	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:  314-251-6573
Montana
	Great Falls
	Big Sky Oncology
		Clinical Trail Office - Big Sky Oncology	Ph:  406-731-8217
	Sletten Cancer Institute at Benefis Healthcare
		Grant Harrer, MD, FACP, CCTI	Ph:  406-455-2820
Nevada
	Las Vegas
	CCOP - Nevada Cancer Research Foundation
		John Ellerton, MD, CM	Ph:  702-384-0013
	University Medical Center of Southern Nevada
		John Ellerton, MD, CM	Ph:  702-383-2000
New Jersey
	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
New York
	Bronx
	Our Lady of Mercy Medical Center Comprehensive Cancer Center
		Peter Wiernik, MD	Ph:  718-304-7200
	East Syracuse
	CCOP - Hematology-Oncology Associates of Central New York
		Jeffrey Kirshner, MD	Ph:  315-472-7504
	Glens Falls
	Charles R. Wood Cancer Center at Glens Falls Hospital
		Clinical Trials Office - Charles R. Wood Cancer Center at Glens Falls Hospital	Ph:  518-926-6700
	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
North Carolina
	Asheville
	Mission Hospitals - Memorial Campus
		Clinical Trials Office - Mission Hospitals - Memorial Campus	Ph:  828-213-4150
	Hendersonville
	Pardee Memorial Hospital
		James Radford, MD	Ph:  828-692-8045
	Kinston
	Kinston Medical Specialists
		Peter Watson, MD	Ph:  252-559-2200 ext. 201
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
	Bellefontaine
	Mary Rutan Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-488-2118
	Bowling Green
	Wood County Oncology Center
		Paul Schaefer, MD	Ph:  419-843-6147
	Canton
	Aultman Cancer Center at Aultman Hospital
		Clinical Trials Office - Aultman Cancer Center at Aultman Hospital	Ph:  330-363-6891
	Chillicothe
	Adena Regional Medical Center
		Clinical Trials Office - Adena Regional Medical Center	Ph:  877-779-7585
	Columbus
	CCOP - Columbus
		J. Philip Kuebler, MD, PhD	Ph:  614-488-2118
	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
	Riverside Methodist Hospital Cancer Care
		Clinical Trials Office - Riverside Methodist Hospital Cancer Care	Ph:  614-566-4475
	Dayton
	CCOP - Dayton
		Howard Gross, MD	Ph:  937-395-8678
	David L. Rike Cancer Center at Miami Valley Hospital
		Clinical Trials Office - David L. Rike Cancer Center at Miami Valley Hospital	Ph:  937-208-2079
	Good Samaritan Hospital
		Howard Gross, MD	Ph:  937-278-2612
	Grandview Hospital
		Howard Gross, MD	Ph:  937-226-3200
	Samaritan North Cancer Care Center
		Howard Gross, MD	Ph:  937-279-5800 800-616-6784
	Veterans Affairs Medical Center - Dayton
		Howard Gross, MD	Ph:  937-268-6511
	Delaware
	Grady Memorial Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-488-2118
	Elyria
	Hematology Oncology Center
		Paul Schaefer, MD	Ph:  419-843-6147
	Findlay
	Blanchard Valley Medical Associates
		Howard Gross, MD	Ph:  419-424-0380
	Franklin
	Middletown Regional Hospital
		Howard Gross, MD	Ph:  513-424-2111
	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:  614-488-2118
	Lima
	Lima Memorial Hospital
		Paul Schaefer, MD	Ph:  419-843-6147
	Marietta
	Strecker Cancer Center at Marietta Memorial Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-488-2118
	Maumee
	Northwest Ohio Oncology Center
		Paul Schaefer, MD	Ph:  419-843-6147
		Paul Schaefer, MD	Ph:  419-843-6147
	St. Luke's Hospital
		Paul Schaefer, MD	Ph:  419-843-6147
	Newark
	Licking Memorial Cancer Care Program at Licking Memorial Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-488-2118
	Oregon
	St. Charles Mercy Hospital
		Paul Schaefer, MD	Ph:  419-843-6147
	Toledo Clinic - Oregon
		Paul Schaefer, MD	Ph:  419-843-6147
	Sandusky
	North Coast Cancer Care, Incorporated
		Paul Schaefer, MD	Ph:  419-843-6147
	Springfield
	Community Hospital of Springfield and Clark County
		J. Philip Kuebler, MD, PhD	Ph:  614-488-2118
	Mercy Medical Center
		J. Philip Kuebler, MD, PhD	Ph:  614-488-2118
	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:  419-843-6147
	Toledo
	CCOP - Toledo Community Hospital
		Paul Schaefer, MD	Ph:  419-843-6147
	Medical University of Ohio Cancer Center
		Clinical Trials Office - Medical University of Ohio Cancer Center	Ph:  419-383-6583
	St. Vincent Mercy Medical Center
		Paul Schaefer, MD	Ph:  419-843-6147
	Toledo Clinic, Incorporated - Main Clinic
		Paul Schaefer, MD	Ph:  419-843-6147
	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:  614-488-2118
	Wilmington
	Clinton Memorial Hospital
		Howard Gross, MD	Ph:  937-382-6611
	Xenia
	Ruth G. McMillan Cancer Center at Greene Memorial Hospital
		Howard Gross, MD	Ph:  937-352-2140
	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:  541-269-8111
Pennsylvania
	Allentown
	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
		Eliot Friedman, MD	Ph:  610-402-0500
	Bethlehem
	St. Luke's Cancer Network at St. Luke's Hospital
		Sanjiv Agarwala, MD	Ph:  412-648-6507
	Philadelphia
	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
	Scranton
	Hematology and Oncology Associates of Northeastern Pennsylvania
		Alvaro Pereira-Rico	Ph:  570-342-3675
		Martin Hyzinski, MD	Ph:  570-558-3020
	Mercy Hospital Cancer Center - Scranton
		Martin Hyzinski, MD	Ph:  570-558-3020
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
	Nashville
	Vanderbilt-Ingram Cancer Center
		Clinical Trials Office - Vanderbilt-Ingram Cancer Center	Ph:  1-800-811-8480;
Texas
	Burleson
	Center for Cancer and Blood Disorders - Burleson
		Ray Page	Ph:  817-551-5312
	Cleburne
	Cleburne Cancer Center
		Ray Page	Ph:  817-648-0120
	Fort Worth
	Center for Cancer and Blood Disorders - Fort Worth
		Ray Page	Ph:  817-333-0100
	Mineral Wells
	Center for Cancer and Blood Disorders - Mineral Wells
		Ray Page	Ph:  940-325-0627
	Weatherford
	Center for Cancer and Blood Disorders - Weatherford
		Ray Page	Ph:  817-596-0637
Virginia
	Fredericksburg
	Fredericksburg Oncology, Incorporated
		Paul Schaefer, MD	Ph:  419-843-6147
Wisconsin
	Appleton
	Fox Valley Hematology and Oncology - East Grant Street
		Timothy Goggins	Ph:  920-749-1171
	Madison
	Dean Medical Center - Madison
		Charles Diggs, MD	Ph:  608-252-8204

Registry Information
Official Title		The BeST Trial: A Randomized Phase II Study of VEGF, RAF Kinase, and mTOR Combination Targeted Therapy (CTT) with Bevacizumab, Sorafenib and Temsirolimus in Advanced Renal Cell Carcinoma [BeST]
Trial Start Date		2007-09-14
Trial Completion Date		2008-09-08 (estimated)
Registered in ClinicalTrials.gov		NCT00378703 1
Date Submitted to PDQ		2006-07-24
Information Last Verified		2008-10-31
NCI Grant/Contract Number		CA21115

Table of Links

1	http://clinicaltrials.gov/ct/show/NCT00378703