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Dasatinib and Bevacizumab in Treating Patients With Recurrent or Progressive High-Grade Glioma or Glioblastoma Multiforme

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, TreatmentActive18 and overNCI, OtherNCCTG-N0872
NCI-2011-01921, CDR0000641746, N0872, NCT00892177

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

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.OBJECTIVES:

PRIMARY OBJECTIVES:

1. Determine the maximum tolerated dose (MTD) of dasatinib in combination with bevacizumab in high grade glioma patients. (Phase I)

2. To assess the safety and adverse events of the dasatinib in combination with bevacizumab in this patient population. (Phase I)

3. To estimate the efficacy of the bevacizumab combination with dasatinib in recurrent glioblastoma multiforme as measured by progression free survival at six months and compare it with the efficacy of bevacizumab alone. (Phase II)

SECONDARY OBJECTIVES:

1. To describe the overall toxicity associated with the dasatinib/bevacizumab combination. (Phase I)

2. To describe any preliminary evidence of antitumor activity. (Phase I)

3. To assess the time to disease progression. (Phase II)

4. To assess the safety and toxicity of the bevacizumab combination with dasatinib in this patient population. (Phase II)

5. To estimate the efficacy of the bevacizumab combination with dasatinib in recurrent glioblastoma multiforme as measured by overall survival time and compare it with the efficacy of bevacizumab alone. (Phase II)

6. To assess the impact of the treatment on the patient's quality of life (QOL) using the overall score from the FACT-Br (Phase II)

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

Eligibility Criteria

Inclusion Criteria:

Phase I: Histologic confirmation of grade 3 or 4 glioma, including astrocytoma, oligodendroglioma, and mixed gliomas, as determined by pre-registration central pathology review
Phase II: Histological confirmation of glioblastoma multiforme (grade 4 astrocytoma) as determined by pre-registration central pathology review; Note: Variant gliosarcomas are eligible

  • Evidence of tumor progression by magnetic resonance imaging (MRI) or computed tomography (CT) scan; Note: 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
  • Measurable or evaluable disease by MRI or CT scan; Note: Patients who have had a gross total resection (GTR) are eligible on the basis of evaluable disease
  • ECOG performance status (PS) 0, 1, or 2
  • Patient willing to discontinue use of aspirin or medications that inhibit platelet function >= 1 week prior to registration
  • Previous radiation therapy (RT) and >= 12 weeks since the completion of RT prior to registration
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Hemoglobin > 9.0 g/dL
  • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 3 x ULN
  • Creatinine =< ULN
  • Urine protein:creatinine (UPC) ratio < 1; NOTE: Urine protein must be screened by urine analysis for UPC ratio; for UPC ratio >= 1.0, 24-hour urine protein must be obtained and the level should be < 1000 mg
  • Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
  • Ability to complete questionnaire(s) by themselves or with assistance
  • Provide written informed consent
  • Willingness to return to Alliance enrolling institution for follow-up
  • Patient willing to provide mandatory tissue samples for research purposes
  • Phase I: Any number of prior chemotherapy regimens for recurrent disease
Phase II: Up to 2 prior chemotherapy regimens with =< 1 regimen for recurrent disease •>= 4 weeks from prior chemotherapy, small molecule cell cycle inhibitors or other investigational agents (>= 6 weeks from nitrosoureas) at the time of registration

Exclusion Criteria:

Any of the following:

  • Pregnant women
  • Nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception during this study and for up to 6 months after bevacizumab treatment has ended
  • Prior intratumoral therapy, stereotactic radiosurgery, or interstitial brachytherapy; EXCEPTION: Separate lesion on MRI, which is not part of the previous treatment field, or convincing evidence of recurrent disease, based on biopsy, MRI spectroscopy, or positron emission tomography (PET) scan
  • Prior treatment with bevacizumab or vascular endothelial growth factor (VEGF)-Trap (aflibercept)
  • Inadequately controlled hypertension (systolic blood pressure of > 150 mm Hg or diastolic pressure > 100 mm Hg on anti-hypertensive medications); NOTE: Patients with well-controlled hypertension are eligible
  • Co-morbid systemic illnesses or other severe concurrent disease which, 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
  • Immunocompromised patients (other than that related to the use of corticosteroids); Note: Patients known to be human immunodeficiency virus (HIV) positive, but without clinical evidence of an immunocompromised state, are eligible for this study
  • Any condition (i.e., 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
  • Receiving therapeutic anticoagulation with warfarin; Note: Prophylactic anticoagulation (i.e., low dose warfarin) of venous or arterial access devices is allowed, provided that international normalized ratio (INR) < 1.5; therapeutic anti-coagulation with low molecular weight heparin is allowed at time of registration
  • Evidence of bleeding diathesis (greater than normal risk of bleeding) or coagulopathy (in the absence of therapeutic anticoagulation)
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  • Other active malignancy =< 3 years prior to registration; EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix; Note: If there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancer
  • History of myocardial infarction or unstable angina =< 6 months prior to registration
  • New York Heart Association (NYHA) classification II, III or IV congestive heart failure
  • Core biopsy or other minor surgical procedures =< 7 days prior to registration; Note: Placement of a vascular access device is allowed
  • Major surgical procedure, open biopsy, or significant traumatic injury =< 28 days prior to registration or anticipation of need for major surgical procedure during the course of the study
  • Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent peripheral arterial thrombosis =< 6 months prior to registration
  • History of hypertensive crisis or hypertensive encephalopathy
  • Known hypersensitivity to any of the components of dasatinib or bevacizumab
  • Serious, nonhealing wound, active ulcer, or untreated bone fracture
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess =< 6 months prior to registration
  • Active or recent history of hemoptysis (>= ½ teaspoon of bright red blood per episode) =< 30 days prior to registration
  • History of stroke or transient ischemic attack (TIA) =< 6 months prior to registration
  • Any evidence of central nervous system (CNS) hemorrhage on baseline CT or MRI
  • Any of the following Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes =< 7 days prior to registration (patients must discontinue drug 7 days prior to starting dasatinib)
* 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
  • Diagnosed congenital long QT syndrome
  • Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
  • Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (> 450 msec)
  • 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)
  • Note: 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; the patient may be referred to a cardiologist at the discretion of the principal investigator; patients with underlying cardiopulmonary dysfunction should be excluded from the study
  • Subjects with hypokalemia or hypomagnesemia if it cannot be corrected prior to dasatinib administration
  • Known pleural or pericardial effusion of any grade
  • Concomitant use of H2 blockers or proton pump inhibitors (PPIs) that cannot be discontinued or switched to locally acting agents (i.e., famotidine or omeprazole)
  • Use of the following enzyme inducing anti-convulsive (EIAC) medications is prohibited =< 7 days prior to registration: carbamazepine (Tegretol, Tegretol XR, Carbatrol), phenytoin (Dilantin, Phenytek), fosphenytoin (Cerebyx), phenobarbital, pentobarbital and primidone (Mysoline); Note: Many antiepileptic drugs induce hepatic enzymes; because dasatinib is metabolized by hepatic enzymes, patients taking antiepileptic medications that induce hepatic enzymes (EIACs) are ineligible for this trial; to be eligible for this trial, patients taking EIACs must be switched to non-EIACs >= 7 days prior to registration; the following agents are not known to affect dasatinib metabolism and are acceptable for use: valproic acid (Depakote, Depacon), gabapentin (Neurontin), lamotrigine (Lamictal), topiramate (Topamax), tiagabine (Gabitril), zonisamide (Zonegran), levetiracetam (Keppra), clonazepam (Klonopin) and clobazam (Frisium)

Trial Contact Information

Trial Lead Organizations/Sponsors

North Central Cancer Treatment Group

National Cancer Institute

Evanthia GalanisStudy Chair

Trial Sites

U.S.A.
California
  LA Jolla
 Rebecca and John Moores UCSD Cancer Center
 Santosh Kesari Ph: 858-822-5354
  Email: cancercto@ucsd.edu
  Pismo Beach
 Palchak David MD
 David L. Palchak Ph: 805-474-9143
Colorado
  Aurora
 Medical Center of Aurora - South Campus
 Keren Sturtz Ph: 888-785-6789
  Boulder
 Boulder Community Hospital
 Keren Sturtz Ph: 888-785-6789
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Keren Sturtz Ph: 888-785-6789
  Denver
 CCOP - Colorado Cancer Research Program
 Keren Sturtz Ph: 888-785-6789
 Porter Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Presbyterian - St. Luke's Medical Center
 Keren Sturtz Ph: 888-785-6789
 Rose Medical Center
 Keren Sturtz Ph: 888-785-6789
 St. Joseph Hospital
 Keren Sturtz Ph: 888-785-6789
  Durango
 Mercy Medical Center
 Cynthia K. Cathcart Ph: 888-785-6789
  Englewood
 Swedish Medical Center
 Keren Sturtz Ph: 888-785-6789
  Greeley
 North Colorado Medical Center
 Keren Sturtz Ph: 888-785-6789
  Lakewood
 St. Anthony Central Hospital
 Keren Sturtz Ph: 888-785-6789
  Littleton
 Littleton Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
  Lone Tree
 Sky Ridge Medical Center
 Eduardo R. Pajon Ph: 888-785-6789
  Longmont
 Hope Cancer Care Center at Longmont United Hospital
 Keren Sturtz Ph: 888-785-6789
  Loveland
 McKee Medical Center
 Keren Sturtz Ph: 888-785-6789
  Parker
 Parker Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
  Pueblo
 St. Mary - Corwin Regional Medical Center
 Keren Sturtz Ph: 888-785-6789
  Wheat Ridge
 Exempla Lutheran Medical Center
 Keren Sturtz Ph: 888-785-6789
Connecticut
  Hartford
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Christopher M Reynolds Ph: 734-712-3456
Delaware
  Lewes
 Tunnell Cancer Center at Beebe Medical Center
 Stephen Scott Grubbs Ph: 302-733-6227
  Newark
 Helen F. Graham Cancer Center at Christiana Hospital
 Stephen Scott Grubbs Ph: 302-733-6227
  Seaford
 Nanticoke Memorial Hospital
 Stephen Scott Grubbs Ph: 302-733-6227
Florida
  Fort Lauderdale
 Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
 Jose Lutzky Ph: 305-674-2625
  Email: info@msccop.com
  Hollywood
 Joe DiMaggio Children's Hospital
 Atif M. Hussein Ph: 954-265-2234
  Jacksonville
 Mayo Clinic - Jacksonville
 Evanthia Galanis Ph: 507-538-7623
  Jupiter
 Ella Milbank Foshay Cancer Center at Jupiter Medical Center
 Jose Lutzky Ph: 305-674-2625
  Email: info@msccop.com
  Miami Beach
 CCOP - Mount Sinai Medical Center
 Jose Lutzky Ph: 305-674-2625
  Email: info@msccop.com
  Orlando
 Florida Hospital Cancer Institute at Florida Hospital Orlando
 Tarek M Mekhail Ph: 407-303-5623
Georgia
  Columbus
 John B. Amos Cancer Center
 Andrew W. Pippas Ph: 706-660-6404
Hawaii
  Aiea
 Kapiolani Medical Center at Pali Momi
 William S. Loui Ph: 808-586-2979
  Email: dorothy@crch.hawaii.edu
 William S. Loui Ph: 808-586-2979
  Email: dorothy@crch.hawaii.edu
  Honolulu
 Cancer Research Center of Hawaii
 William S. Loui Ph: 808-586-2979
  Email: dorothy@crch.hawaii.edu
 Kapiolani Medical Center for Women and Children
 William S. Loui Ph: 808-586-2979
  Email: dorothy@crch.hawaii.edu
 Kuakini Medical Center
 William S. Loui Ph: 808-586-2979
  Email: dorothy@crch.hawaii.edu
 OnCare Hawaii, Incorporated - Kuakini
 William S. Loui Ph: 808-586-2979
  Email: dorothy@crch.hawaii.edu
 William S. Loui Ph: 808-586-2979
  Email: dorothy@crch.hawaii.edu
 OnCare Hawaii, Incorporated - Lusitana
 William S. Loui Ph: 808-586-2979
  Email: dorothy@crch.hawaii.edu
 Queen's Cancer Institute at Queen's Medical Center
 William S. Loui Ph: 808-586-2979
  Email: dorothy@crch.hawaii.edu
 Straub Clinic and Hospital, Incorporated
 William S. Loui Ph: 808-586-2979
  Email: dorothy@crch.hawaii.edu
  Kailua
 Castle Medical Center
 William S. Loui Ph: 808-586-2979
  Email: dorothy@crch.hawaii.edu
  Lihue
 Kauai Medical Clinic
 William S. Loui Ph: 808-586-2979
  Email: dorothy@crch.hawaii.edu
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Christopher M Reynolds Ph: 734-712-3456
  Post Falls
 Kootenai Cancer Center - Post Falls
 Benjamin Thomas Marchello Ph: 800-648-6274
Illinois
  Aurora
 Rush-Copley Cancer Care Center
 Kendrith M. Rowland Ph: 800-446-5532
  Bloomington
 Illinois CancerCare - Bloomington
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Canton
 Illinois CancerCare - Canton
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Carthage
 Illinois CancerCare - Carthage
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Eureka
 Illinois CancerCare - Eureka
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Galesburg
 Galesburg Clinic, PC
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Medical and Surgical Specialists, LLC
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Kewanee
 Illinois CancerCare - Kewanee Clinic
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Macomb
 Illinois CancerCare - Macomb
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Monmouth
 Illinois CancerCare - Monmouth
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Normal
 Community Cancer Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Ottawa
 Illinois CancerCare - Ottawa
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Pekin
 Cancer Treatment Center at Pekin Hospital
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Illinois CancerCare - Pekin
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Peoria
 CCOP - Illinois Oncology Research Association
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Illinois CancerCare - Peoria
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Methodist Medical Center of Illinois
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Peru
 Illinois CancerCare - Princeton
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Princeton
 Illinois CancerCare - Princeton
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Urbana
 Carle Cancer Center at Carle Foundation Hospital
 Kendrith M. Rowland Ph: 800-446-5532
Indiana
  Beech Grove
 St. Francis Hospital and Health Centers - Beech Grove Campus
 Howard M. Gross Ph: 765-983-3000
  Indianapolis
 St. Francis Hospital Cancer Care Services
 Howard M. Gross Ph: 765-983-3000
  Richmond
 Reid Hospital & Health Care Services
 Howard M. Gross Ph: 317-783-8918
Iowa
  Ames
 McFarland Clinic, PC
 Joseph James Merchant Ph: 515-239-2621
  Clive
 Medical Oncology and Hematology Associates-West Des Moines
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Mercy Cancer Center - West Lakes
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
  Des Moines
 CCOP - Iowa Oncology Research Association
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 John Stoddard Cancer Center at Iowa Lutheran Hospital
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 John Stoddard Cancer Center at Iowa Methodist Medical Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Medical Oncology and Hematology Associates at John Stoddard Cancer Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Medical Oncology and Hematology Associates at Mercy Cancer Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Mercy Cancer Center at Mercy Medical Center - Des Moines
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
  Mason City
 Mercy Cancer Center at Mercy Medical Center - North Iowa
 Arvind Y Vemula Ph: 800-433-3883
  Sioux City
 Mercy Medical Center - Sioux City
 Donald Bruce Wender Ph: 712-252-0088
 Siouxland Hematology-Oncology Associates, LLP
 Donald Bruce Wender Ph: 712-252-0088
 St. Luke's Regional Medical Center
 Donald Bruce Wender Ph: 712-252-0088
  West Des Moines
 Methodist West Hospital
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
Kansas
  Chanute
 Cancer Center of Kansas, PA - Chanute
 Shaker R. Dakhil Ph: 316-262-4467
  Dodge City
 Cancer Center of Kansas, PA - Dodge City
 Shaker R. Dakhil Ph: 316-262-4467
  El Dorado
 Cancer Center of Kansas, PA - El Dorado
 Shaker R. Dakhil Ph: 316-262-4467
  Fort Scott
 Cancer Center of Kansas - Fort Scott
 Shaker R. Dakhil Ph: 316-262-4467
  Independence
 Cancer Center of Kansas-Independence
 Shaker R. Dakhil Ph: 316-262-4467
  Kingman
 Cancer Center of Kansas, PA - Kingman
 Shaker R. Dakhil Ph: 316-262-4467
  Lawrence
 Lawrence Memorial Hospital
 Shaker R. Dakhil Ph: 316-262-4467
  Liberal
 Cancer Center of Kansas, PA - Liberal
 Shaker R. Dakhil Ph: 316-262-4467
  Manhattan
 Cancer Center of Kansas-Manhattan
 Shaker R. Dakhil Ph: 316-262-4467
  McPherson
 Cancer Center of Kansas, PA - McPherson
 Shaker R. Dakhil Ph: 316-262-4467
  Newton
 Cancer Center of Kansas, PA - Newton
 Shaker R. Dakhil Ph: 316-262-4467
  Parsons
 Cancer Center of Kansas, PA - Parsons
 Shaker R. Dakhil Ph: 316-262-4467
  Pratt
 Cancer Center of Kansas, PA - Pratt
 Shaker R. Dakhil Ph: 316-262-4467
  Salina
 Cancer Center of Kansas, PA - Salina
 Shaker R. Dakhil Ph: 316-262-4467
  Wellington
 Cancer Center of Kansas, PA - Wellington
 Shaker R. Dakhil Ph: 316-262-4467
  Wichita
 Associates in Women's Health, PA - North Hillside
 Shaker R. Dakhil Ph: 316-262-4467
 Cancer Center of Kansas, PA - Medical Arts Tower
 Shaker R. Dakhil Ph: 316-262-4467
 Cancer Center of Kansas, PA - Wichita
 Shaker R. Dakhil Ph: 316-262-4467
 CCOP - Wichita
 Shaker R. Dakhil Ph: 316-262-4467
 Via Christi Cancer Center at Via Christi Regional Medical Center
 Shaker R. Dakhil Ph: 316-262-4467
 Wesley Medical Center
 Shaker R. Dakhil Ph: 316-262-4467
  Winfield
 Cancer Center of Kansas, PA - Winfield
 Shaker R. Dakhil Ph: 316-262-4467
Maine
  Augusta
 Harold Alfond Center for Cancer Care
 Thomas Henry Openshaw Ph: 207-973-4274
  Bangor
 CancerCare of Maine at Eastern Maine Medical Center
 Thomas Henry Openshaw Ph: 207-973-4274
Massachusetts
  Boston
 Tufts Medical Center Cancer Center
 Lynne P Taylor Ph: 617-636-5000
  Email: ContactUsCancerCenter@TuftsMedicalCenter.org
Michigan
  Adrian
 Hickman Cancer Center at Bixby Medical Center
 Rex B Mowat Ph: 517-265-0116
 Rex B Mowat Ph: 517-265-0116
  Ann Arbor
 CCOP - Michigan Cancer Research Consortium
 Christopher M Reynolds Ph: 734-712-3456
 Saint Joseph Mercy Cancer Center
 Christopher M Reynolds Ph: 734-712-3456
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Christopher M Reynolds Ph: 734-712-3456
  Detroit
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Christopher M Reynolds Ph: 734-712-3456
  Flint
 Genesys Hurley Cancer Institute
 Christopher M Reynolds Ph: 734-712-3456
 Hurley Medical Center
 Christopher M Reynolds Ph: 734-712-3456
  Jackson
 Gayle M. Jacob Cancer Center at Allegiance Health
 Christopher M Reynolds Ph: 734-712-3456
  Kalamazoo
 Borgess Medical Center
 Raymond Sterling Lord Ph: 269-373-7458
 Bronson Methodist Hospital
 Raymond Sterling Lord Ph: 269-373-7458
 West Michigan Cancer Center
 Raymond Sterling Lord Ph: 269-373-7458
  Lansing
 Sparrow Regional Cancer Center
 Christopher M Reynolds Ph: 734-712-3456
  Livonia
 St. Mary Mercy Hospital
 Christopher M Reynolds Ph: 734-712-3456
  Monroe
 Community Cancer Center of Monroe
 Rex B Mowat Ph: 517-265-0116
 Mercy Memorial Hospital - Monroe
 Rex B Mowat Ph: 517-265-0116
  Pontiac
 St. Joseph Mercy Oakland
 Christopher M Reynolds Ph: 734-712-3456
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Christopher M Reynolds Ph: 734-712-3456
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Christopher M Reynolds Ph: 734-712-3456
  Warren
 St. John Macomb Hospital
 Christopher M Reynolds Ph: 734-712-3456
Minnesota
  Bemidji
 MeritCare Bemidji
 Preston D. Steen Ph: 701-234-6161
  Burnsville
 Fairview Ridges Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Coon Rapids
 Mercy and Unity Cancer Center at Mercy Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Edina
 Fairview Southdale Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Fergus Falls
 Lake Region Healthcare Corporation-Cancer Care
 Preston D. Steen Ph: 701-234-6161
  Fridley
 Mercy and Unity Cancer Center at Unity Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Hutchinson
 Hutchinson Area Health Care
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Maplewood
 HealthEast Cancer Care at St. John's Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Minnesota Oncology - Maplewood
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Minneapolis
 Hennepin County Medical Center - Minneapolis
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  New Ulm
 New Ulm Medical Center
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Robbinsdale
 Humphrey Cancer Center at North Memorial Outpatient Center
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Rochester
 Mayo Clinic Cancer Center
 Evanthia Galanis Ph: 507-538-7623
 North Central Cancer Treatment Group
 Evanthia Galanis Ph: 507-284-3902
  Email: galanis.evanthia@mayo.edu
  Saint Cloud
 CentraCare Clinic - Women and Children
 Donald J Jurgens Ph: 877-229-4907
  Email: coborncancercenter@centracare.com
 Coborn Cancer Center
 Donald J Jurgens Ph: 877-229-4907
  Email: coborncancercenter@centracare.com
  Saint Louis Park
 CCOP - Metro-Minnesota
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Park Nicollet Cancer Center
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Saint Paul
 Regions Hospital Cancer Care Center
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 United Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Shakopee
 St. Francis Cancer Center at St. Francis Medical Center
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Stillwater
 Lakeview Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Waconia
 Ridgeview Medical Center
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Willmar
 Willmar Cancer Center at Rice Memorial Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Woodbury
 Minnesota Oncology - Woodbury
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
Missouri
  Saint Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 David D Tran Ph: 800-600-3606
  Email: info@siteman.wustl.edu
Montana
  Billings
 Billings Clinic Cancer Center - 801 N 29th Street
 Benjamin Thomas Marchello Ph: 800-648-6274
 CCOP - Montana Cancer Consortium
 Benjamin Thomas Marchello Ph: 800-648-6274
 St. Vincent Healthcare Cancer Care Services
 Benjamin Thomas Marchello Ph: 800-648-6274
  Bozeman
 Bozeman Deaconess Cancer Center
 Benjamin Thomas Marchello Ph: 800-648-6274
  Butte
 St. James Healthcare Cancer Care
 Benjamin Thomas Marchello Ph: 800-648-6274
  Great Falls
 Benefis Sletten Cancer Institute
 Benjamin Thomas Marchello Ph: 800-648-6274
  Helena
 St. Peter's Hospital
 Benjamin Thomas Marchello Ph: 800-648-6274
  Missoula
 Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
 Benjamin Thomas Marchello Ph: 800-648-6274
 Montana Cancer Specialists at Montana Cancer Center
 Benjamin Thomas Marchello Ph: 800-648-6274
Nebraska
  Lincoln
 Cancer Resource Center - Lincoln
 Gamini S. Soori Ph: 800-253-4368
  Omaha
 Alegant Health Cancer Center at Bergan Mercy Medical Center
 Gamini S. Soori Ph: 800-253-4368
 CCOP - Missouri Valley Cancer Consortium
 Gamini S. Soori Ph: 800-253-4368
 Creighton University Medical Center
 Gamini S. Soori Ph: 800-253-4368
 Immanuel Medical Center
 Gamini S. Soori Ph: 800-253-4368
 Lakeside Hospital
 Gamini S. Soori Ph: 800-253-4368
 UNMC Eppley Cancer Center at the University of Nebraska Medical Center
 Nicole A Shonka Ph: 800-999-5465
Nevada
  Las Vegas
 CCOP - Nevada Cancer Research Foundation
 John Allan Ellerton Ph: 702-384-0013
 University Medical Center of Southern Nevada
 John Allan Ellerton Ph: 702-384-0013
New Hampshire
  Concord
 New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
 Frederick M. Briccetti Ph: 800-339-6484
  Hooksett
 New Hampshire Oncology - Hematology, PA - Hooksett
 Frederick M. Briccetti Ph: 800-339-6484
  Laconia
 Lakes Region General Hospital
 Frederick M. Briccetti Ph: 800-339-6484
  Lebanon
 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
 Camilo E. Fadul Ph: 800-639-6918
  Email: cancer.research.nurse@dartmouth.edu
New York
  Mount Kisco
 Northern Westchester Hospital
 Jonathan S Goldberg Ph: 914-666-1366
  Email: skloiber@nwhc.net
  New York
 Mount Sinai Medical Center
 Philip A Friedlander Ph: 212-824-7320
  Email: jenny.figueroa@mssm.edu
North Carolina
  Goldsboro
 Wayne Memorial Hospital, Incorporated
 James N. Atkins Ph: 919-580-0000
  Kinston
 Kinston Medical Specialists
 Peter R. Watson Ph: 252-559-2200
  Winston-Salem
 Wake Forest University Comprehensive Cancer Center
 Glenn J Lesser Ph: 336-713-6771
North Dakota
  Bismarck
 Bismarck Cancer Center
 John T Reynolds Ph: 701-323-5760
  Email: tfischer@mohs.org
 Medcenter One Hospital Cancer Care Center
 John T Reynolds Ph: 701-323-5760
  Email: tfischer@mohs.org
  Fargo
 Roger Maris Cancer Center at MeritCare Hospital
 Preston D. Steen Ph: 701-234-6161
 Preston D. Steen Ph: 701-234-6161
 Sanford Clinic North-Fargo
 Preston D. Steen Ph: 701-234-6161
  Grand Forks
 Altru Cancer Center at Altru Hospital
 Grant R Seeger Ph: 701-780-6520
Ohio
  Bowling Green
 Wood County Oncology Center
 Rex B Mowat Ph: 517-265-0116
  Dayton
 CCOP - Dayton
 Howard M. Gross Ph: 317-783-8918
 David L. Rike Cancer Center at Miami Valley Hospital
 Howard M. Gross Ph: 765-983-3000
 Good Samaritan Hospital
 Howard M. Gross Ph: 765-983-3000
  Findlay
 Blanchard Valley Regional Cancer Center
 Howard M. Gross Ph: 317-783-8918
  Franklin
 Atrium Medical Center
 Howard M. Gross Ph: 317-783-8918
  Greenville
 Wayne Hospital
 Howard M. Gross Ph: 317-783-8918
  Kettering
 Charles F. Kettering Memorial Hospital
 Howard M. Gross Ph: 317-783-8918
  Lima
 Lima Memorial Hospital
 Rex B Mowat Ph: 517-265-0116
  Maumee
 Northwest Ohio Oncology Center
 Rex B Mowat Ph: 517-265-0116
  Oregon
 St. Charles Mercy Hospital
 Rex B Mowat Ph: 517-265-0116
 Toledo Clinic - Oregon
 Rex B Mowat Ph: 517-265-0116
  Sylvania
 Flower Hospital Cancer Center
 Rex B Mowat Ph: 517-265-0116
  Tiffin
 Mercy Hospital of Tiffin
 Rex B Mowat Ph: 517-265-0116
  Toledo
 CCOP - Toledo Community Hospital
 Rex B Mowat Ph: 517-265-0116
 St. Anne Mercy Hospital
 Rex B Mowat Ph: 517-265-0116
 St. Vincent Mercy Medical Center
 Rex B Mowat Ph: 517-265-0116
 Toledo Clinic, Incorporated - Main Clinic
 Rex B Mowat Ph: 517-265-0116
 University of Toledo Medical Center
 Rex B Mowat Ph: 517-265-0116
  Troy
 UVMC Cancer Care Center at Upper Valley Medical Center
 Howard M. Gross Ph: 317-783-8918
  Wauseon
 Fulton County Health Center
 Rex B Mowat Ph: 517-265-0116
  Wright-Patterson Afb
 United States Air Force Medical Center - Wright-Patterson
 Brandon J Cutler Ph: 937-257-1398
Oklahoma
  Norman
 Cancer Care Associates - Norman
 Vikki Ann Canfield Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
  Oklahoma City
 Cancer Care Associates - Mercy Campus
 Vikki Ann Canfield Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Oregon
  Gresham
 Legacy Mount Hood Medical Center
 Regan M Look Ph: 503-413-1742
  Portland
 Legacy Good Samaritan Hospital & Comprehensive Cancer Center
 Regan M Look Ph: 503-413-1742
  Tualatin
 Legacy Meridian Park Hospital
 Regan M Look Ph: 503-413-1742
Pennsylvania
  Allentown
 Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
 Suresh G. Nair Ph: 610-402-2273
  Bethlehem
 Lehigh Valley Hospital - Muhlenberg
 Suresh G. Nair Ph: 610-402-2273
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Maged F Khalil Ph: 610-402-2273
  Hazleton
 Geisinger Hazleton Cancer Center
 Maged F Khalil Ph: 610-402-2273
  State College
 Geisinger Medical Group - Scenery Park
 Maged F Khalil Ph: 610-402-2273
  Wilkes-Barre
 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
 Maged F Khalil Ph: 610-402-2273
Rhode Island
  Providence
 Rhode Island Hospital Comprehensive Cancer Center
 Suriya Jeyapalan Ph: 401-444-1488
South Carolina
  Florence
 McLeod Regional Medical Center
 Rajesh Bajaj Ph: 843-679-7256
  Greenville
 Cancer Centers of the Carolinas - Faris Road
 Jeffrey Kent Giguere Ph: 864-241-6251
 Cancer Centers of the Carolinas - Grove Commons
 Jeffrey Kent Giguere Ph: 864-241-6251
 CCOP - Greenville
 Jeffrey Kent Giguere Ph: 864-241-6251
 Greenville Memorial Hospital
 Jeffrey Kent Giguere Ph: 864-241-6251
  Seneca
 Cancer Centers of the Carolinas - Seneca
 Jeffrey Kent Giguere Ph: 864-241-6251
  Spartanburg
 Cancer Centers of the Carolinas - Spartanburg
 Jeffrey Kent Giguere Ph: 864-241-6251
South Dakota
  Rapid City
 Rapid City Regional Hospital
 Mark T Schroeder Ph: 605-716-3982
  Email: research@rcrh.org
  Sioux Falls
 Avera Cancer Institute
 Addison R Tolentino Ph: 800-657-4377
  Email: Jan.Healy@avera.org
 Sanford Cancer Center at Sanford USD Medical Center
 Miroslaw A Mazurczak Ph: 605-328-1367
 Miroslaw A Mazurczak Ph: 605-328-1367
Virginia
  Charlottesville
 University of Virginia Cancer Center
 David Schiff Ph: 434-243-6143
  Fredericksburg
 Fredericksburg Oncology Inc
 Rex B Mowat Ph: 517-265-0116
Washington
  Vancouver
 Legacy Salmon Creek Medical Center
 Regan M Look Ph: 503-413-1742
Wisconsin
  Eau Claire
 Marshfield Clinic Cancer Care at Regional Cancer Center
 Benjamin E. Lawler Ph: 715-389-4457
  La Crosse
 Gundersen Lutheran Center for Cancer and Blood
 Kurt Oettel Ph: 608-775-2385
  Email: cancerctr@gundluth.org
  Marshfield
 Marshfield Clinic - Marshfield Center
 Benjamin E. Lawler Ph: 715-389-4457
  Milwaukee
 Froedtert Hospital and Medical College of Wisconsin
 Jennifer M Connelly Ph: 414-805-4380
  Minocqua
 Marshfield Clinic - Lakeland Center
 Benjamin E. Lawler Ph: 715-389-4457
  Mukwonago
 D.N. Greenwald Center
 Timothy R Wassenaar Ph: 262-928-7878
  New Richmond
 Cancer Center of Western Wisconsin
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Oconomowoc
 Regional Cancer Center at Oconomowoc Memorial Hospital
 Timothy R Wassenaar Ph: 262-928-7878
  Rhinelander
 Ministry Medical Group at Saint Mary's Hospital
 Benjamin E. Lawler Ph: 715-389-4457
  Rice Lake
 Marshfield Clinic - Indianhead Center
 Benjamin E. Lawler Ph: 715-389-4457
  Stevens Point
 Marshfield Clinic at Saint Michael's Hospital
 Benjamin E. Lawler Ph: 715-389-4457
  Waukesha
 Waukesha Memorial Hospital Regional Cancer Center
 Timothy R Wassenaar Ph: 262-928-7878
  Wausau
 Marshfield Clinic - Wausau Center
 Benjamin E. Lawler Ph: 715-389-4457
  Weston
 Marshfield Clinic - Weston Center
 Benjamin E. Lawler Ph: 715-389-4457
  Wisconsin Rapids
 Marshfield Clinic - Wisconsin Rapids Center
 Benjamin E. Lawler Ph: 715-389-4457
Wyoming
  Casper
 Rocky Mountain Oncology
 Benjamin Thomas Marchello Ph: 800-648-6274
  Sheridan
 Welch Cancer Center at Sheridan Memorial Hospital
 Benjamin Thomas Marchello Ph: 800-648-6274

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00892177
ClinicalTrials.gov processed this data on October 17, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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