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

Basic Trial Information

Trial Description

Summary

RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also block the growth of the tumor by blocking blood flow to the tumor. It is not yet known whether bevacizumab together with dasatinib are more effective than a placebo in treating patients with recurrent or progressive high-grade glioma or glioblastoma multiforme.

PURPOSE: This randomized phase I/II trial (Phase I completed) is studying the side effects and best dose of dasatinib when given together with bevacizumab and to see how well it works compared to placebo in treating patients with recurrent or progressive high-grade glioma or glioblastoma multiforme.

Further Study Information

OBJECTIVES:

Primary

• Determine the maximum-tolerated dose of dasatinib in combination with bevacizumab in patients with recurrent or progressive high-grade glioma or glioblastoma multiforme. (Phase I*)

• Assess the safety and adverse events of this regimen in these patients. (Phase I*)

• Estimate and compare the efficacy of these regimens in these patients as measured by progression-free survival at six months. (Phase II)

Secondary

• Describe any preliminary evidence of antitumor activity. (Phase I*)

• Describe the overall toxicity associated with this regimen in these patients. (Phase I*)

• Estimate and compare the efficacy of these regimens in these patients as measured by overall survival (Phase II)

• Assess the impact of these regimens on the patient's quality of life using FACT-Br (no longer assessed as of 5/18/2009) (newly added as of 2/2/2010). (Phase II)

• Assess the time to disease progression. (Phase II)

• Assess the safety and toxicity of these regimens in this patient population. (Phase II)

• Determine the relationship between tumor biomarkers and clinical outcome of patients treated with these regimens. (Phase II) (exploratory)

• Assess the utility of dynamic contrast-enhanced MRI as a predictor of response to these regimens. (Phase II) (exploratory)

• To assess the utility of MRI diffusion-weighted images (DWI), and specifically the apparent diffusion coefficient (ADC), as a predictor of response and survival in patients treated with bevacizumab/dasatinib combination treatment. (Phase II) (exploratory)

• Bank leftover tissue for future NCCTG studies. (Phase II) (exploratory) NOTE: *Phase I completed.

OUTLINE: This is a multicenter, phase I, dose-escalation study (Phase I completed) of dasatinib followed by a phase II randomized study. Patients are grouped according to study (1 vs 2). Patients in the phase II portion are stratified according to age (> 70 years of age vs ≤ 70 years of age), and ECOG performance status (0 vs 1 or 2).

Phase I: Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oral dasatinib once or twice daily on days 1-14 until the maximum-tolerated dose (MTD) is determined. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. (Phase I completed)

Phase II (patients are randomized to 1 of 2 treatment arms):

• Arm I: Patients receive bevacizumab as in phase I and dasatinib at the MTD as determined in phase I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

• Arm II: Patients receive bevacizumab as in phase I and oral placebo once or twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed by FACT-Br questionnaire at baseline and prior to every other course (no longer assessed as of 5/18/2009)(newly added as of 2/2/2010). Tissue samples are collected at baseline for biomarker studies and assessed by IHC, RT-PCR, and FISH. Patients undergo dynamic contrast-enhanced MRI at baseline, day 3 of course 1, and day 1 of course 2.

After completion of study therapy, patients are followed up periodically for up to 3 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed diagnosis of 1 of the following:

• Grade 3 or 4 glioma, including astrocytoma, oligodendroglioma, and mixed gliomas (Phase I)

• Glioblastoma* multiforme (grade 4 astrocytoma) (Phase II) NOTE: *Variant gliosarcomas are allowed

• Evidence of tumor recurrence or progression by MRI or CT scan following radiotherapy or most recent antitumor therapy

• Patients who have had surgical treatment at recurrence are eligible if they had a subtotal resection with measurable or non-measurable residual disease on postoperative imaging or if there is imaging evidence of disease progression as compared to the first postoperative scan

• Bidimensionally measurable or evaluable disease by MRI or CT scan

• Patients who have had a gross total resection (GTR) are eligible on the basis of evaluable disease

• No known pleural or pericardial effusion of any grade

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• ANC ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Hemoglobin > 9.0 g/dL

• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

• SGOT ≤ 3 times ULN

• Creatinine normal

• Urine protein:creatinine ratio < 1 or urine protein < 1,000 mg on 24-hour urine collection

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment

• Able to complete questionnaires with or without assistance

• Willing to return to NCCTG enrolling institution for follow-up

• Willing to provide mandatory tissue samples for research purposes

• QTc interval ≤ 450 msec

• No congenital long QT syndrome

• No uncontrolled hypertension (systolic BP of > 150 mm Hg or diastolic BP > 100 mm Hg on antihypertensive medications)

• Well-controlled hypertension allowed

• No myocardial infarction or unstable angina within the past 6 months

• No NYHA class II-IV congestive heart failure

• No significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent peripheral arterial thrombosis within the past 6 months

• No history of any clinically significant ventricular arrhythmias (i.e., ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)

• No stroke or transient ischemic attack within the past 6 months

• No history of hypertensive crisis or hypertensive encephalopathy

• No evidence of any CNS hemorrhage on baseline CT or MRI

• No co-morbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

• No immunocompromised patients (other than that related to the use of corticosteroids)

• Known HIV positivity without clinical evidence of an immunocompromised state allowed

• No condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation or prior surgical procedures affecting absorption) that impairs ability to swallow pills

• No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months

• No evidence of bleeding diathesis (greater than normal risk of bleeding) or coagulopathy (in the absence of therapeutic anticoagulation)

• No active or recent history of hemoptysis (≥ ½ teaspoon of bright red blood per episode) within the past 30 days

• No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness or social situations that would limit compliance with study requirements

• No other active malignancy within the past 3 years except for nonmelanoma skin cancer or carcinoma in situ of the cervix

• No known hypersensitivity to any of the components of dasatinib or bevacizumab

• No significant traumatic injury within the past 28 days

• No serious nonhealing wounds, active ulcers, or untreated bone fractures

• No hypokalemia or hypomagnesemia that cannot be corrected prior to dasatinib administration

• Patients may not have any clinically significant cardiovascular disease including the following:

• Myocardial infarction or ventricular tachyarrhythmia within 6 months

• Prolonged QTc ≥ 480 msec (Fridericia correction)

• Ejection fraction less than institutional normal

• Major conduction abnormality (unless a cardiac pacemaker is present)

• Patients with any cardiopulmonary symptoms of unknown cause (e.g., shortness of breath, chest pain, etc.) should be evaluated by a baseline echocardiogram with or without stress test as needed in addition to electrocardiogram (ECG) to rule out QTc prolongation

• Patients with underlying cardiopulmonary dysfunction should be excluded from the study

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Any number of prior chemotherapy regimens for recurrent disease allowed (Phase I)

• No more than 4 weeks since prior chemotherapy, small-molecule cell-cycle inhibitors, or other investigational agents (≥ 6 weeks since nitrosoureas) at the time of registration

• More than 1 week since prior aspirin or medications that inhibit platelet function

• No more than 2 prior chemotherapy regimens with ≤ 1 regimen for recurrent disease (Phase II)

• No prior bevacizumab or VEGF-Trap (Aflibercept)

• No prior intratumoral therapy, stereotactic radiosurgery, or interstitial brachytherapy except for the following:

• Separate lesion on MRI that is not part of the previous treatment field

• Evidence of recurrent disease based on biopsy, MRI spectroscopy, or PET scan

• At least 7 days since prior core biopsy or other minor surgical procedures (placement of a vascular access device is allowed)

• At least 7 days since prior drugs that have a risk of causing Torsades de Pointes, including any of the following:

• Quinidine, procainamide, disopyramide

• Amiodarone, sotalol, ibutilide, dofetilide

• Erythromycin, clarithromycin

• Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide

• Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine

• Prochlorperazine

• At least 28 days since prior and no concurrent major surgical procedure or open biopsy

• At least 12 weeks since prior radiotherapy

• No concurrent therapeutic anticoagulation with warfarin, except low-dose warfarin for venous or arterial access devices, provided INR < 1.5

• Therapeutic anticoagulation with low molecular weight heparin allowed

• No other concurrent investigational agent considered as a therapy for the primary neoplasm

• No concurrent therapy (other than hormonal therapy) for other prior malignancy

• No concurrent H_2 blockers or proton pump inhibitors that cannot be discontinued or switched to locally acting agents (i.e., famotidine, omeprazole, Maalox, Mylanta, or Tums)

• Use of the following enzyme-inducing anticonvulsive (EIAC) medications is prohibited ≤ 7 days prior to registration: carbemazepine (Tegretol®, Tegretol XR®, Carbatrol®), phenytoin (Dilantin®, Phenytek®), fosphenytoin (Cerebyx®), phenobarbital, pentobarbital, and primidone (Mysoline®)

• The following agents are not known to affect dasatinib metabolism and are acceptable for use: valproic acid (Depakote®, Depacon®), gabapentin (Neurontin®), lomotrigine (Lamictal®), topiramate (Topamax®), tiagabine (Gabitril®), zonisamid (Zonegram®), levetriacetam (Keppra®), clonazepam (Klonipin®), and clonozam (Frisium®)

Trial Contact Information

Trial Lead Organizations/Sponsors

North Central Cancer Treatment Group

Evanthia Galanis

Study Chair

U.S.A.
Arizona
	Scottsdale
	Mayo Clinic Scottsdale
		Clinical Trials Office - All Mayo Clinic Locations	Ph: 507-538-7623
California
	La Jolla
	Rebecca and John Moores UCSD Cancer Center
		Clinical Trials Office - Rebecca and John Moores UCSD Cancer	Ph: 858-822-5354
			Email: cancercto@ucsd.edu
Colorado
	Aurora
	Aurora Presbyterian Hospital
		Eduardo R. Pajon, MD	Ph: 303-399-8020ext2261
	Boulder
	Boulder Community Hospital
		Clinical Trials Office - Boulder Community Hospital	Ph: 303-938-5253
	Colorado Springs
	Penrose Cancer Center at Penrose Hospital
		Clinical Trials Office - Penrose Cancer Center	Ph: 719-776-5275
	Denver
	Porter Adventist Hospital
		Eduardo R. Pajon, MD	Ph: 303-399-8020ext2261
	Presbyterian - St. Luke's Medical Center
		Clinical Trials Office - Presbyterian - St. Luke's Medical Cen	Ph: 303-839-6000
	Rose Medical Center
		Eduardo R. Pajon, MD	Ph: 303-399-8020ext2261
	St. Anthony Central Hospital
		Eduardo R. Pajon, MD	Ph: 303-399-8020ext2261
	St. Joseph Hospital
		Eduardo R. Pajon, MD	Ph: 303-399-8020ext2261
	Englewood
	Swedish Medical Center
		Eduardo R. Pajon, MD	Ph: 303-399-8020ext2261
	Greeley
	North Colorado Medical Center
		Eduardo R. Pajon, MD	Ph: 303-399-8020ext2261
	Lone Tree
	Sky Ridge Medical Center
		Eduardo R. Pajon, MD	Ph: 303-399-8020ext2261
	Longmont
	Hope Cancer Care Center at Longmont United Hospital
		Eduardo R. Pajon, MD	Ph: 303-399-8020ext2261
	Loveland
	McKee Medical Center
		Eduardo R. Pajon, MD	Ph: 303-399-8020ext2261
	Pueblo
	St. Mary - Corwin Regional Medical Center
		Eduardo R. Pajon, MD	Ph: 303-399-8020ext2261
	Wheat Ridge
	Exempla Lutheran Medical Center
		Clinical Trials Office - Exempla Lutheran Medical Center	Ph: 303-403-3605
Connecticut
	Hartford
	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
		Christopher M. Reynolds	Ph: 860-714-4680
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: 302-623-4450
District of Columbia
	Washington
	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
		Clinical Trials Office - Lombardi Comprehensive Cancer Center	Ph: 202-444-0381
Florida
	Fort Lauderdale
	Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
		Clinical Trials Office - Michael and Dianne Bienes Comprehensi	Ph: 954-776-3239
	Hollywood
	Memorial Cancer Institute at Memorial Regional Hospital
		Clinical Trials Office - Memorial Cancer Institute	Ph: 954-985-3443
	Jacksonville
	Mayo Clinic - Jacksonville
		Clinical Trials Office - All Mayo Clinic Locations	Ph: 507-538-7623
	Jupiter
	Ella Milbank Foshay Cancer Center at Jupiter Medical Center
		Clinical Trials Office - Ella Milbank Foshay Cancer Center	Ph: 561-745-5768
	Miami Beach
	CCOP - Mount Sinai Medical Center
		Jose Lutzky, MD	Ph: 305-535-3305
	Orlando
	Florida Hospital Cancer Institute at Florida Hospital Orlando
		Clinical Trials Office - Florida Hospital Cancer Institute	Ph: 407-303-5623
Hawaii
	Aiea
	Kapiolani Medical Center at Pali Momi
		William S. Loui, MD, FACP	Ph: 808-524-6115
	Oncare Hawaii, Incorporated - Pali Momi
		William S. Loui, MD, FACP	Ph: 808-524-6115
	Honolulu
	Cancer Research Center of Hawaii
		Clinical Trials Office - Cancer Research Center of Hawaii	Ph: 808-586-2979
	Kapiolani Medical Center for Women and Children
		William S. Loui, MD, FACP	Ph: 808-524-6115
	Kuakini Medical Center
		William S. Loui, MD, FACP	Ph: 808-524-6115
	OnCare Hawaii, Incorporated - Kuakini
		William S. Loui, MD, FACP	Ph: 808-524-6115
	OnCare Hawaii, Incorporated - Lusitana
		William S. Loui, MD, FACP	Ph: 808-524-6115
	Queen's Cancer Institute at Queen's Medical Center
		William S. Loui, MD, FACP	Ph: 808-524-6115
	Straub Clinic and Hospital, Incorporated
		William S. Loui, MD, FACP	Ph: 808-524-6115
	Kailua
	Castle Medical Center
		William S. Loui, MD, FACP	Ph: 808-524-6115
	Lihue
	Kauai Medical Clinic
		William S. Loui, MD, FACP	Ph: 808-524-6115
Idaho
	Boise
	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
		Clinical Trials Office - Saint Alphonsus Cancer Care Center	Ph: 208-367-7954
Illinois
	Aurora
	Rush-Copley Cancer Care Center
		Kendrith M. Rowland, MD	Ph: 217-383-3019
	Bloomington
	Illinois CancerCare - Bloomington
		Nguyet A. Le-Lindqwister	Ph: 309-662-2102
	Canton
	Illinois CancerCare - Canton
		Nguyet A. Le-Lindqwister	Ph: 309-647-5240
	Carthage
	Illinois CancerCare - Carthage
		Nguyet A. Le-Lindqwister	Ph: 217-357-6877
	Chicago
	Rush Cancer Institute at Rush University Medical Center
		Clinical Trials Office - Rush University Medical Center	Ph: 312-942-5498
			Email: clinical_trials@rush.edu
	Eureka
	Eureka Community Hospital
		Nguyet A. Le-Lindqwister	Ph: 309-467-2371
	Illinois CancerCare - Eureka
		Nguyet A. Le-Lindqwister	Ph: 309-467-2371
	Galesburg
	Galesburg Clinic, PC
		Nguyet A. Le-Lindqwister	Ph: 309-344-1000
	Havana
	Illinois CancerCare - Havana
		Nguyet A. Le-Lindqwister	Ph: 309-543-8557
	Kewanee
	Illinois CancerCare - Kewanee Clinic
		Nguyet A. Le-Lindqwister	Ph: 309-852-0598
	Macomb
	Illinois CancerCare - Macomb
		Nguyet A. Le-Lindqwister	Ph: 309-833-3503
	Monmouth
	Illinois CancerCare - Monmouth
		Nguyet A. Le-Lindqwister	Ph: 309-734-3141
	Normal
	BroMenn Regional Medical Center
		Nguyet A. Le-Lindqwister	Ph: 309-454-1400
	Community Cancer Center
		Nguyet A. Le-Lindqwister	Ph: 309-451-8500
	Illinois CancerCare - Community Cancer Center
		Nguyet A. Le-Lindqwister	Ph: 309-662-2102
	Ottawa
	Community Hospital of Ottawa
		Nguyet A. Le-Lindqwister	Ph: 815-433-3100
	Oncology Hematology Associates of Central Illinois, PC - Ottawa
		Nguyet A. Le-Lindqwister	Ph: 815-431-9270
	Pekin
	Cancer Treatment Center at Pekin Hospital
		Nguyet A. Le-Lindqwister	Ph: 309-353-0512
	Illinois CancerCare - Pekin
		Nguyet A. Le-Lindqwister	Ph: 309-353-0214
	Peoria
	CCOP - Illinois Oncology Research Association
		Nguyet A. Le-Lindqwister	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
		Nguyet A. Le-Lindqwister	Ph: 309-243-3000
	Proctor Hospital
		Nguyet A. Le-Lindqwister	Ph: 309-691-1000
	Peru
	Illinois CancerCare - Peru
		Nguyet A. Le-Lindqwister	Ph: 815-780-3185
	Illinois Valley Community Hospital
		Nguyet A. Le-Lindqwister	Ph: 815-223-3000
	Princeton
	Illinois CancerCare - Princeton
		Nguyet A. Le-Lindqwister	Ph: 815-875-3010
	Spring Valley
	Illinois CancerCare - Spring Valley
		Nguyet A. Le-Lindqwister	Ph: 815-664-1487
	Urbana
	CCOP - Carle Cancer Center
		Clinical Trials Office - CCOP - Carle Cancer Center	Ph: 800-446-5532
Indiana
	Indianapolis
	St. Francis Hospital Cancer Care Services
		Howard M. Gross, MD	Ph: 937-832-1093
	Richmond
	Reid Hospital & Health Care Services
		Howard M. Gross, MD	Ph: 937-832-1093
Iowa
	Ames
	McFarland Clinic, PC
		Clinical Trials Office - McFarland Clinic, PC	Ph: 515-239-2621
	Clive
	Medical Oncology and Hematology Associates - West Des Moines
		Robert J. Behrens	Ph: 515-875-9713
	Mercy Cancer Center - West Lakes
		Robert J. Behrens	Ph: 515-643-8206
	Des Moines
	CCOP - Iowa Oncology Research Association
		Robert J. Behrens	Ph: 515-244-7586
	John Stoddard Cancer Center at Iowa Lutheran Hospital
		Clinical Trials Office - John Stoddard Cancer Center at Iowa L	Ph: 515-241-8704
	John Stoddard Cancer Center at Iowa Methodist Medical Center
		Clinical Trials Office - John Stoddard Cancer Center at Iowa M	Ph: 515-241-6727
	Medical Oncology and Hematology Associates at John Stoddard Cancer Center
		Robert J. Behrens	Ph: 515-282-2921
	Medical Oncology and Hematology Associates at Mercy Cancer Center
		Robert J. Behrens	Ph: 515-643-8740
	Mercy Cancer Center at Mercy Medical Center - Des Moines
		Robert J. Behrens	Ph: 515-643-8206
	Mason City
	Mercy Cancer Center at Mercy Medical Center - North Iowa
		Clinical Trials Office - Mercy Cancer Center at Mercy Medical	Ph: 641-422-6304
	Sioux City
	Mercy Medical Center - Sioux City
		Donald B. Wender, MD, PhD	Ph: 712-252-0088
	Siouxland Hematology-Oncology Associates, LLP
		Donald B. Wender, MD, PhD	Ph: 712-252-0088
	St. Luke's Regional Medical Center
		Donald B. Wender, MD, PhD	Ph: 712-252-0088
	West Des Moines
	Methodist West Hospital
		Robert J. Behrens	Ph: 515-343-1000
Kansas
	Chanute
	Cancer Center of Kansas, PA - Chanute
		Shaker R. Dakhil, MD, FACP	Ph: 316-262-4467
	Dodge City
	Cancer Center of Kansas, PA - Dodge City
		Shaker R. Dakhil, MD, FACP	Ph: 316-262-4467
	El Dorado
	Cancer Center of Kansas, PA - El Dorado
		Shaker R. Dakhil, MD, FACP	Ph: 316-262-4467
	Fort Scott
	Cancer Center of Kansas - Fort Scott
		Shaker R. Dakhil, MD, FACP	Ph: 316-262-4467
	Independence
	Cancer Center of Kansas-Independence
		Shaker R. Dakhil, MD, FACP	Ph: 316-262-4467
	Kingman
	Cancer Center of Kansas, PA - Kingman
		Shaker R. Dakhil, MD, FACP	Ph: 316-262-4467
	Lawrence
	Lawrence Memorial Hospital
		Shaker R. Dakhil, MD, FACP	Ph: 316-262-4467
	Liberal
	Cancer Center of Kansas, PA - Liberal
		Shaker R. Dakhil, MD, FACP	Ph: 316-262-4467
	Newton
	Cancer Center of Kansas, PA - Newton
		Shaker R. Dakhil, MD, FACP	Ph: 316-262-4467
	Parsons
	Cancer Center of Kansas, PA - Parsons
		Shaker R. Dakhil, MD, FACP	Ph: 316-262-4467
	Pratt
	Cancer Center of Kansas, PA - Pratt
		Shaker R. Dakhil, MD, FACP	Ph: 316-262-4467
	Salina
	Cancer Center of Kansas, PA - Salina
		Shaker R. Dakhil, MD, FACP	Ph: 316-262-4467
	Wellington
	Cancer Center of Kansas, PA - Wellington
		Shaker R. Dakhil, MD, FACP	Ph: 316-262-4467
	Wichita
	Associates in Womens Health, PA - North Review
		Shaker R. Dakhil, MD, FACP	Ph: 316-262-4467
	Cancer Center of Kansas, PA - Medical Arts Tower
		Shaker R. Dakhil, MD, FACP	Ph: 316-262-4467
	Cancer Center of Kansas, PA - Wichita
		Shaker R. Dakhil, MD, FACP	Ph: 316-262-4467
	CCOP - Wichita
		Shaker R. Dakhil, MD, FACP	Ph: 316-262-4467
	Via Christi Cancer Center at Via Christi Regional Medical Center
		Shaker R. Dakhil, MD, FACP	Ph: 316-262-4467
	Wesley Medical Center
		Shaker R. Dakhil, MD, FACP	Ph: 316-262-4467
	Winfield
	Cancer Center of Kansas, PA - Winfield
		Shaker R. Dakhil, MD, FACP	Ph: 316-262-4467
Maine
	Augusta
	Harold Alfond Center for Cancer Care
		Thomas H. Openshaw	Ph: 207-621-6100
	Bangor
	CancerCare of Maine at Eastern Maine Medical Center
		Clinical Trials Office - CancerCare of Maine	Ph: 207-973-4274
Maryland
	Elkton MD
	Union Hospital of Cecil County
		Stephen S. Grubbs, MD	Ph: 302-366-1200
Michigan
	Adrian
	Hickman Cancer Center at Bixby Medical Center
		Clinical Trials Office - Hickman Cancer Center at Bixby Medica	Ph: 517-265-0116
	Ann Arbor
	CCOP - Michigan Cancer Research Consortium
		Christopher M. Reynolds	Ph: 877-590-5995
	Saint Joseph Mercy Cancer Center
		Christopher M. Reynolds	Ph: 734-712-5658
	Dearborn
	Oakwood Cancer Center at Oakwood Hospital and Medical Center
		Clinical Trials Office - Oakwood Cancer Center at Oakwood Hosp	Ph: 313-593-8090
	Flint
	Hurley Medical Center
		Clinical Trials Office - Hurley Medical Center	Ph: 810-762-8057
	Grosse Pointe Woods
	Van Elslander Cancer Center at St. John Hospital and Medical Center
		Clincial Trials Office - Van Elslander Cancer Center at St. Jo	Ph: 313-343-3166
	Jackson
	Foote Memorial Hospital
		Christopher M. Reynolds	Ph: 517-788-4800
	Lansing
	Sparrow Regional Cancer Center
		Clinical Trials Office - Sparrow Regional Cancer Center	Ph: 517-364-2890
	Livonia
	St. Mary Mercy Hospital
		Christopher M. Reynolds	Ph: 734-464-4800
	Monroe
	Community Cancer Center of Monroe
		Rex B. Mowat	Ph: 734-242-7902
	Mercy Memorial Hospital - Monroe
		Rex B. Mowat	Ph: 734-240-8400
	Pontiac
	St. Joseph Mercy Oakland
		Christopher M. Reynolds	Ph: 248-858-3612
	Port Huron
	Mercy Regional Cancer Center at Mercy Hospital
		Christopher M. Reynolds	Ph: 810-985-1484
	Saginaw
	Seton Cancer Institute at Saint Mary's - Saginaw
		Clinical Trials Office - Seton Cancer Institute - Saginaw	Ph: 989-776-8411
	Warren
	St. John Macomb Hospital
		Christopher M. Reynolds	Ph: 586-573-5757
Minnesota
	Bemidji
	MeritCare Bemidji
		Preston D. Steen, MD	Ph: 701-234-2397
	Burnsville
	Fairview Ridges Hospital
		Daniel M. Anderson	Ph: 952-892-2000
	Coon Rapids
	Mercy and Unity Cancer Center at Mercy Hospital
		Daniel M. Anderson	Ph: 763-236-6000
	Duluth
	CCOP - Duluth
		Bret E.B. Friday	Ph: 218-786-8364
	Essentia Health - Duluth Clinic
		Clinical Trials Office - Essentia Health - Duluth Clinic	Ph: 218-786-3308
	Miller - Dwan Medical Center
		Bret E.B. Friday	Ph: 218-727-8762
	Edina
	Fairview Southdale Hospital
		Clinical Trials Office - Fairview Southdale Hospital	Ph: 612-625-3650
	Fridley
	Mercy and Unity Cancer Center at Unity Hospital
		Daniel M. Anderson	Ph: 763-236-5000
	Hutchinson
	Hutchinson Area Health Care
		Daniel M. Anderson	Ph: 320-234-5000
	Maplewood
	HealthEast Cancer Care at St. John's Hospital
		Daniel M. Anderson	Ph: 651-232-7970
	Minnesota Oncology - Maplewood
		Daniel M. Anderson	Ph: 651-779-7978
	Minneapolis
	Hennepin County Medical Center - Minneapolis
		Clinical Trials Office - Hennepin County Medical Center - Minn	Ph: 612-873-5911
	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
		Clinical Trials Office - Virginia Piper Cancer Institute	Ph: 612-863-5654
	Robbinsdale
	Humphrey Cancer Center at North Memorial Outpatient Center
		Clinical Trials Office - Humphrey Cancer Center at North Memor	Ph: 763-520-1893
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph: 507-538-7623
	Saint Cloud
	CentraCare Clinic - River Campus
		Donald J. Jurgens	Ph: 320-252-5131
	Coborn Cancer Center
		Donald J. Jurgens	Ph: 320-229-4907
	Saint Louis Park
	CCOP - Metro-Minnesota
		Daniel M. Anderson	Ph: 952-993-1517
	Park Nicollet Cancer Center
		Daniel M. Anderson	Ph: 952-993-3248
	Saint Paul
	United Hospital
		Daniel M. Anderson	Ph: 651-241-8000
	Shakopee
	St. Francis Cancer Center at St. Francis Medical Center
		Daniel M. Anderson	Ph: 952-403-2031
	St. Paul
	Regions Hospital Cancer Care Center
		Clinical Trials Office - Regions Hospital Cancer Care Center	Ph: 651-254-1517
	Stillwater
	Lakeview Hospital
		Daniel M. Anderson	Ph: 651-439-5330
	Waconia
	Ridgeview Medical Center
		Daniel M. Anderson	Ph: 952-442-2191
	Willmar
	Willmar Cancer Center at Rice Memorial Hospital
		Daniel M. Anderson	Ph: 320-231-4650
	Woodbury
	Minnesota Oncology - Woodbury
		Daniel M. Anderson	Ph: 651-735-7414
Missouri
	Saint Louis
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		David D. Tran	Ph: 314-747-7222
Montana
	Billings
	Billings Clinic - Downtown
		Clinical Trials Office - Billings Clinic - Downtown	Ph: 800-996-2663
			Email: research@billingsclinic.org
	CCOP - Montana Cancer Consortium
		Benjamin T. Marchello, MD	Ph: 406-238-6290
	Hematology-Oncology Centers of the Northern Rockies - Billings
		Benjamin T. Marchello, MD	Ph: 406-238-6290
	St. Vincent Healthcare Cancer Care Services
		Benjamin T. Marchello, MD	Ph: 406-238-6290
	Bozeman
	Bozeman Deaconess Cancer Center
		Benjamin T. Marchello, MD	Ph: 406-238-6290
	Butte
	St. James Healthcare Cancer Care
		Benjamin T. Marchello, MD	Ph: 406-238-6290
	Great Falls
	Benefis Sletten Cancer Institute
		Grant W. Harrer, MD, FACP, CCTI	Ph: 406-731-8100
	Helena
	St. Peter's Hospital
		Benjamin T. Marchello, MD	Ph: 406-238-6290
	Kalispell
	Kalispell Regional Medical Center
		Benjamin T. Marchello, MD	Ph: 406-238-6290
	Missoula
	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
		Clinical Trials Office - Montana Cancer Center at St. Patrick	Ph: 406-329-7029
	Montana Cancer Specialists at Montana Cancer Center
		Clinical Trials Office - Montana Cancer Specialists at Montana	Ph: 406-238-6962
Nebraska
	Grand Island
	Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
		Nicole A. Shonka	Ph: 308-398-5450
	Lincoln
	Cancer Resource Center - Lincoln
		Gamini S. Soori, MD, FACP, FRCP, MBA	Ph: 402-393-3110
	North Platte
	Callahan Cancer Center at Great Plains Regional Medical Center
		Clinical Trials Office - Callahan Cancer Center at Great Plain	Ph: 308-696-7864
	Omaha
	Alegant Health Cancer Center at Bergan Mercy Medical Center
		Clinical Trials Office - Alegant Health Cancer Center at Berge	Ph: 402-398-6060
	CCOP - Missouri Valley Cancer Consortium
		Gamini S. Soori, MD, FACP, FRCP, MBA	Ph: 402-393-3110
	Creighton University Medical Center
		Clinical Trials Office - Creighton University Medical Center	Ph: 402-280-4100
	Immanuel Medical Center
		Gamini S. Soori, MD, FACP, FRCP, MBA	Ph: 402-393-3110
	Lakeside Hospital
		Gamini S. Soori, MD, FACP, FRCP, MBA	Ph: 402-393-3110
	UNMC Eppley Cancer Center at the University of Nebraska Medical Center
		Clinical Trials Office - UNMC Eppley Cancer Center at the Univ	Ph: 800-999-5465
New Hampshire
	Concord
	New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
		Frederick M. Briccetti, MD	Ph: 603-224-2556
	Hooksett
	New Hampshire Oncology - Hematology, PA - Hooksett
		Frederick M. Briccetti, MD	Ph: 603-224-2556
	Laconia
	Lakes Region General Hospital
		Frederick M. Briccetti, MD	Ph: 603-224-2556
	Lebanon
	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
		Clinical Trials Office - Norris Cotton Cancer Center	Ph: 603-650-7609
			Email: cancerhelp@dartmouth.edu
New Jersey
	Ridgewood
	Valley Hospital - Ridgewood
		Eli D. Kirshner	Ph: 201-634-5339
	Voorhees
	Cancer Institute of New Jersey at Cooper - Voorhees
		Clinical Trials Office - Cancer Institute of New Jersey at Coo	Ph: 856-325-6757
New York
	New York
	Mount Sinai Medical Center
		Philip A. Friedlander	Ph: 212-241-6500
North Carolina
	Goldsboro
	Wayne Memorial Hospital, Incorporated
		James N. Atkins, MD	Ph: 919-580-0000
	Kinston
	Kinston Medical Specialists
		Peter R. Watson, MD	Ph: 252-559-2200ext.201
North Dakota
	Bismarck
	Medcenter One Hospital Cancer Care Center
		John T. Reynolds	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 Cen	Ph: 701-530-6950
	Fargo
	Dakota Cancer Institute at Dakota Clinic - South University
		Bret E.B. Friday	Ph: 701-364-8910
	MeritCare Broadway
		Preston D. Steen, MD	Ph: 701-234-2397
	Grand Forks
	Altru Cancer Center at Altru Hospital
		Clinical Trails Office - Altru Cancer Center at Altru Hospital	Ph: 701-780-6520
Ohio
	Bowling Green
	Wood County Oncology Center
		Rex B. Mowat	Ph: 419-352-9498
	Cincinnati
	Charles M. Barrett Cancer Center at University Hospital
		Howard M. Gross, MD	Ph: 937-832-1093
	Dayton
	CCOP - Dayton
		Howard M. Gross, MD	Ph: 937-832-1093
	David L. Rike Cancer Center at Miami Valley Hospital
		Clinical Trials Office - David L. Rike Cancer Center at Miami	Ph: 937-208-2079
	Good Samaritan Hospital
		Howard M. Gross, MD	Ph: 937-832-1093
	Grandview Hospital
		Howard M. Gross, MD	Ph: 937-832-1093
	Samaritan North Cancer Care Center
		Howard M. Gross, MD	Ph: 937-832-1093
	Elyria
	Community Cancer Center
		Rex B. Mowat	Ph: 440-324-0400
	Hematology Oncology Center
		Rex B. Mowat	Ph: 440-324-0401
	Findlay
	Blanchard Valley Medical Associates
		Howard M. Gross, MD	Ph: 937-832-1093
	Franklin
	Middletown Regional Hospital
		Howard M. Gross, MD	Ph: 937-832-1093
	Greenville
	Wayne Hospital
		Howard M. Gross, MD	Ph: 937-832-1093
	Kettering
	Charles F. Kettering Memorial Hospital
		Clinical Trials Office - Charles F. Kettering Memorial Hospita	Ph: 937-298-3399 ext. 57556
	Lima
	Lima Memorial Hospital
		Rex B. Mowat	Ph: 419-228-3335
	Maumee
	Northwest Ohio Oncology Center
		Rex B. Mowat	Ph: 419-891-5600
	Oregon
	St. Charles Mercy Hospital
		Rex B. Mowat	Ph: 419-696-7200
	Toledo Clinic - Oregon
		Rex B. Mowat	Ph: 419-691-4235
	Sylvania
	Flower Hospital Cancer Center
		Clinical Trials Office - Flower Hospital Cancer Center	Ph: 419-824-1842
	Tiffin
	Mercy Hospital of Tiffin
		Rex B. Mowat	Ph: 419-447-3130
	Toledo
	Medical University of Ohio Cancer Center
		Clinical Trials Office - Medical University of Ohio Cancer Cen	Ph: 419-383-6583
	St. Anne Mercy Hospital
		Rex B. Mowat	Ph: 419-407-2663
	St. Vincent Mercy Medical Center
		Rex B. Mowat	Ph: 419-251-4515
	Toledo Clinic, Incorporated - Main Clinic
		Rex B. Mowat	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 Vall	Ph: 937-440-4842
	Wauseon
	Fulton County Health Center
		Clinical Trials Office - Fulton County Health Center	Ph: 419-330-2708
	West Chester
	Precision Radiotherapy at University Pointe
		Howard M. Gross, MD	Ph: 937-832-1093
	Xenia
	Ruth G. McMillan Cancer Center at Greene Memorial Hospital
		Howard M. Gross, MD	Ph: 937-832-1093
Oklahoma
	Norman
	Cancer Care Associates - Norman
		Vikki A. Canfield, MD	Ph: 405-751-4343
	Oklahoma City
	Cancer Care Associates - Mercy Campus
		Vikki A. Canfield, MD	Ph: 405-751-4343
Pennsylvania
	Allentown
	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
		Suresh G. Nair, MD	Ph: 610-402-0512
South Carolina
	Florence
	McLeod Regional Medical Center
		Clinical Trials Office - McLeod Regional Medical Center	Ph: 843-679-7256
	Greenville
	Cancer Centers of the Carolinas - Faris Road
		Jeffrey K. Giguere, MD, FACP	Ph: 864-987-7000
	Cancer Centers of the Carolinas - Grove Commons
		Clinical Trials Office - Cancer Centers of the Carolinas	Ph: 864-241-6251
	CCOP - Greenville
		Jeffrey K. Giguere, MD, FACP	Ph: 864-987-7000
	Greenville Hospital Cancer Center
		Clinical Trials Office - Greenville Hospital Cancer Center	Ph: 864-241-6251
	Greer
	Cancer Centers of the Carolinas - Greer Medical Oncology
		Jeffrey K. Giguere, MD, FACP	Ph: 864-987-7000
	Seneca
	Cancer Centers of the Carolinas - Seneca
		Jeffrey K. Giguere, MD, FACP	Ph: 864-987-7000
	Spartanburg
	Cancer Centers of the Carolinas - Spartanburg
		Jeffrey K. Giguere, MD, FACP	Ph: 864-987-7000
South Dakota
	Rapid City
	Rapid City Regional Hospital
		Richard C. Tenglin	Ph: 605-719-2360
	Sioux Falls
	Avera Cancer Institute
		Addison R. Tolentino	Ph: 605-322-3000
	Sanford Cancer Center at Sanford USD Medical Center
		Clinical Trials Office - Sanford Cancer Center	Ph: 605-328-1367
Virginia
	Fredericksburg
	Fredericksburg Oncology, Incorporated
		Rex B. Mowat	Ph: 540-368-0500
Wisconsin
	La Crosse
	Gundersen Lutheran Center for Cancer and Blood
		Clinical Trials Office - Gundersen Lutheran Cancer Center	Ph: 608-775-2385
			Email: cancerctr@gundluth.org
	Oconomowoc
	Regional Cancer Center at Oconomowoc Memorial Hospital
		Clinical Trials Office - Regional Cancer Center at Oconomowoc	Ph: 262-928-7878
	Waukesha
	Waukesha Memorial Hospital Regional Cancer Center
		Clinical Trials Office - Waukesha Memorial Hospital Regional C	Ph: 262-928-7632

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00892177
Information obtained from ClinicalTrials.gov on February 21, 2013

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