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Erlotinib Hydrochloride and Cabozantinib-s-Malate Alone or In Combination as Second or Third Line Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer

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 overNCINCI-2012-01938
CDR0000741879, ECOG-E1512, E1512, U10CA021115, NCT01708954

Trial Description

Summary

This randomized phase II trial studies how well giving erlotinib hydrochloride and cabozantinib-s-malate alone or in combination works as second or third line therapy in treating patient with stage IV non-small cell lung cancer. Erlotinib hydrochloride and cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving erlotinib hydrochloride together with cabozantinib-s-malate is more effective than erlotinib hydrochloride or cabozantinib-s-malate alone in treating non-small cell lung cancer.

Further Study Information

PRIMARY OBJECTIVES:

I. To compare the progression-free survival (PFS) associated with patients treated with erlotinib (erlotinib hydrochloride) vs. erlotinib plus cabozantinib (cabozantinib-s-malate).

II. To compare the PFS associated with patients treated with erlotinib vs. cabozantinib.

SECONDARY OBJECTIVES:

I. To evaluate overall survival in the three treatment arms. II. To evaluate best objective response rate in the three treatment arms. III. To define the toxicity associated with each regimen. IV. To conduct correlative science studies that will help to select predictive biomarkers of response to therapy, including hepatocyte growth factor receptor (MET) expression and potentially other tissue biomarkers, plasma biomarkers, and bone scans.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM A: Patients receive erlotinib hydrochloride orally (PO) daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive cabozantinib-s-malate PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM C: Patients receive erlotinib hydrochloride as patients in Arm A and cabozantinib-s-malate as patients in Arm B. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM Z: Patients achieving disease progression in Arm A or Arm B may receive erlotinib hydrochloride and cabozantinib-s-malate as patients in Arm C. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Eligibility Criteria

Inclusion Criteria:

  • STEP 1:
  • Cytologically or histologically confirmed non-small cell lung carcinoma (NSCLC)
  • Predominant non-squamous histology (patients with NSCLC not otherwise specified [NOS] are eligible); mixed tumors will be categorized by the predominant cell type; if small cell elements are present the patient is ineligible
  • Stage IV disease (includes M1a, M1b, or recurrent disease), according to the 7th edition of the lung cancer TNM classification system
  • The tumor must not have a sensitizing mutation in epidermal growth factor receptor (EGFR), defined as follows:
  • EGFR mutation testing of tumor has been performed and did not demonstrate an EGFR tyrosine kinase inhibitor sensitizing mutation at minimum, testing for EGFR exon 19 deletion and exon 21 L858R mutations must have been included; OR
  • EGFR mutation testing has been attempted and is inconclusive (for example, due to lack of sufficient deoxyribonucleic acid [DNA] yield); OR
  • EGFR mutation status is unknown but tumor is positive for at least one alternative driver mutation, i.e: Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation, v-raf murine sarcoma viral oncogene homolog B (BRAF) mutation, v-erb-b2 avian erythroblastic leukemia viral oncogene homolog 2 (HER2) mutation, ret proto-oncogene (RET) rearrangement/fusion, or one not listed following approval by the study chair prior to registration
  • Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 criteria; baseline measurements and evaluation of ALL sites of disease must be obtained within 4 weeks prior to registration
  • Prior to registration, the investigator/site must confirm that sufficient pathology material representative of patient's cancer is available for submission for MET immunohistochemical testing; patients for whom there is not sufficient pathology material representative of the patient's cancer (tumor block or 10 unstained slides) are not eligible to participate in this study
  • Patients must have received one or two lines of prior chemotherapy (first line platinum-doublet based chemotherapy plus switch maintenance chemotherapy counts as one line of therapy); prior adjuvant chemotherapy for early stage disease does not count as one line of therapy if 12 months or greater elapsed between completion of adjuvant therapy and initiation of first-line systemic therapy; if less than 12 months elapsed, adjuvant chemotherapy counts as one line of therapy
  • No prior erlotinib, other EGFR tyrosine kinase inhibitor therapy, vascular endothelial growth factor (VEGRF) tyrosine kinase inhibitor therapy, Met tyrosine kinase inhibitor therapy, or Met monoclonal antibody (MetMAb); prior antibody therapy such as bevacizumab or cetuximab is allowed with a washout period depending on dosing interval and investigational nature
  • Any prior chemotherapy (based on administration schedule) must have been completed in greater than or equal to the following times prior to registration:
  • Chemotherapy administered in a daily schedule must be completed >= 2 weeks prior to registration
  • Chemotherapy administered in a weekly schedule must be completed >= 2 weeks prior to registration
  • Chemotherapy administered in a 2-weekly schedule must be completed >= 3 weeks prior to registration
  • Chemotherapy administered in a 3-weekly schedule must be completed >= 4 weeks prior to registration
  • Patients must have discontinued treatment with any other type of investigational agent >= 4 weeks prior to registration
  • Patients must have recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
  • Patients with no known brain metastasis at baseline must have baseline brain imaging within 12 weeks prior to study registration not demonstrating brain metastases; patients with brain metastases at baseline must have baseline brain imagining within 4 weeks prior to study registration and meet all of the following criteria:
  • Have completed treatment to all active brain metastases (with whole brain radiation or radiosurgery) >= 2 weeks prior to registration, or have undergone complete neurosurgical resection >= 3 months prior to registration;
  • Be asymptomatic from brain metastases at time of screening;
  • Not require steroid treatment or enzyme inducing anticonvulsant drugs for at least 2 weeks prior to registration; non-enzyme inducing anti-epileptic drugs (NEIAED) such as levetiracetam are allowed;
  • Known leptomeningeal disease or epidural disease is not allowed
  • Patients must not have received radiation therapy to the thoracic cavity, abdomen, or pelvis within 3 months prior to registration, to bone or brain metastasis within 14 days prior to registration, or to any other site within 28 days prior to registration
  • Radiation related toxicities must have resolved to =< grade 1 prior to registration
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-2
  • Patients must have an anticipated life expectancy greater than 3 months
  • Leukocytes >= 3,000/mm^3
  • Absolute neutrophil count >= 1,500/ mm^3
  • Platelets >= 100,000/mm^3
  • Hemoglobin >= 9 g/dL
  • Total bilirubin =< 1.5 institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 3 x ULN
  • Serum albumin >= 2.8 g/dL
  • Lipase =< 2.0 x ULN and no radiologic or clinical evidence of pancreatitis
  • Serum phosphorus* >= institutional lower limit of normal (LLN)
  • Serum calcium* (absolute or albumin corrected) >= LLN
  • Serum magnesium* >= LLN
  • Serum potassium* >= LLN
  • * Note: Serum phosphorus, calcium, magnesium and potassium can be replaced if values are below LLN
  • Creatinine =< 1.5 x ULN or calculated or measured creatinine clearance >= 50 mL/min/1.73 m^2 (normalized to body surface area [BSA]) for patients with creatinine levels above institutional normal
  • Screening urine dipstick must equal 0 or "trace"; if urine dipstick results are >= 1+, calculation of urine protein creatinine (UPC) is required and patients must have a UPC ratio =< 1 to participate in the study
  • Prothrombin time (PT)/ international normalized ratio (INR) and partial thromboplastin time (PTT) test =< 1.3 x ULN
  • No history of the following:
  • Clinically-significant gastrointestinal bleeding within 6 months prior to registration
  • Hemoptysis of >= 0.5 teaspoon (2.5 mL) of red blood within 3 months prior to registration
  • Any other signs indicative of pulmonary hemorrhage within 3 months prior to registration
  • No radiographic or other evidence of within 28 days prior to registration:
  • Tumor invading the gastrointestinal (GI) tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor
  • Cavitating pulmonary lesion(s)
  • Tumor in contact with, invading or encasing any major blood vessels
  • No patients with psychiatric illness/social situations that would limit compliance with study requirements
  • No history of major thrombotic events (deep vein thrombosis [DVT] or pulmonary embolism [PE]) within 6 months prior to registration; Note: subjects with a venous filter (e.g. vena cava filter) are not eligible for this study
  • No concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, low molecular weight heparin (LMWH), thrombin or Factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel [clopidogrel bisulfate]); (low dose aspirin [=< 81 mg/day] and prophylactic LMWH are permitted)
  • No concomitant treatment of strong cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John's wort)
  • No cardiovascular disorders including:
  • Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening
  • Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic, or > 100 mm Hg diastolic despite optimal antihypertensive treatment within 7 days prior to registration
  • Any history of congenital long QT syndrome
  • Any of the following within 6 months prior to registration:
  • Unstable angina pectoris
  • Clinically-significant cardiac arrhythmias
  • Stroke (including transient ischemic attack [TIA], or other ischemic event)
  • Myocardial infarction
  • No gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including:
  • Any of the following within 28 days prior to registration
  • Intra-abdominal tumor/metastases invading GI mucosa
  • Active peptic ulcer disease
  • Inflammatory bowel disease (including ulcerative colitis and Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis
  • Malabsorption syndrome
  • Any of the following within 6 months prior to registration:
  • Abdominal fistula
  • Gastrointestinal perforation
  • Bowel obstruction or gastric outlet obstruction
  • Intra-abdominal abscess; Note: complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more than 6 months prior to registration
  • No other disorders associated with a high risk of fistula formation including percutaneous endoscopic gastrostomy (PEG) tube placement within 3 months prior to registration
  • No uncontrolled, significant, intercurrent or recent illness including, but not limited to, the following conditions:
  • Grade 3 or greater infection, or infection requiring intravenous systemic treatment within 28 days prior to registration; patients should be off antibiotics at the time of registration
  • Serious non-healing wound/ulcer/bone fracture within 28 days prior to registration
  • History of organ transplant
  • Concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days prior to registration
  • History of surgery as follows:
  • Major surgery (as an example, surgery requiring anesthesia and a > 24 hour hospital stay) within 3 months prior to registration if there were no wound healing complications or within 6 months prior to registration if there were wound complications
  • Minor surgery (such as chest tube placement, but not including thoracentesis or paracentesis) within 28 days prior to registration if there were no wound healing complications or within 3 months prior to registration if there were wound complications
  • In addition, complete wound healing from prior surgery and procedures must be confirmed prior to registration
  • Patients must have corrected QT interval calculated by the Fridericia formula (QTcF) =< 500 ms within 28 days before registration
  • Patients must be able to swallow tablets
  • No prior malignancy within 2 years prior to registration which required systemic treatment or is currently active
  • Women must not be pregnant or breast-feeding; for this reason, all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
  • Has not undergone a hysterectomy or bilateral oophorectomy; or
  • Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (e.g. male or female condom) during the course of the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used; all sexually active subjects of reproduction potential must agree to use both a barrier method and a second method of birth control during the course of the study and for 4 months after the last dose of study drug(s)
  • Patients with known human immunodeficiency virus (HIV) disease taking antiretroviral therapy are excluded
  • Patients with known chronic active hepatitis B (defined as a positive hepatitis B surface antigen and/or hepatitis B viral load in the last 12 months) are excluded, regardless of antiviral treatment
  • STEP 2: Patients must have met all eligibility requirements for Step 1 at time of registration to Step 1 to be eligible for Step 2
  • STEP 2: Patients must have radiographic progressive disease per RECIST criteria after >= 2 courses of therapy on Arm A or Arm B
  • STEP 2: Patients must not have intervening anticancer treatment or major surgical procedure(s) between Step 1 and Step 2, except palliative radiation to the bone finishing >= 2 weeks prior to registration to Step 2
  • STEP 2: Patients may not have central nervous system progression but patients with stable central nervous system (CNS) disease are allowed
  • STEP 2: Patients must be registered to Step 2 within 4 weeks of the last dose of treatment administration from Step 1
  • STEP 2: Patients must have an ECOG performance status between 0-2
  • STEP 2: Patients must have recovered to baseline (pre-Step 1) or CTCAE =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant AEs
  • STEP 2: Leukocytes >= 3,000/mm^3
  • STEP 2: Absolute neutrophil count >= 1,500/mm^3
  • STEP 2: Platelets >= 100,000/mm^3
  • STEP 2: Hemoglobin >= 9 g/dL
  • STEP 2: Total bilirubin =< 1.5 x ULN
  • STEP 2: AST(SGOT) and ALT(SGPT) =< 3 x ULN
  • STEP 2: Serum albumin >= 2.8 g/dL
  • STEP 2: Lipase =< 2.0 x ULN and no radiologic or clinical evidence of pancreatitis
  • STEP 2: Serum phosphorus* >= LLN
  • STEP 2: Serum calcium* (absolute or albumin corrected) >= LLN
  • STEP 2: Serum magnesium* >= LLN
  • STEP 2: Serum potassium* >= LLN
  • * NOTE: Serum phosphorus, calcium, magnesium and potassium can be replaced if values are below LLN
  • STEP 2: Creatinine =< 1.5 x ULN or calculated or measured creatinine clearance >= 50 mL/min/1.73 m^2 (normalized to BSA) for patients with creatinine levels above institutional normal
  • STEP 2: Screening urine dipstick must equal 0; if urine dipstick results are >= 1+, calculation of UPC is required and patients must have a UPC ration =< 1 to participate in the study
  • STEP 2: Patients must have corrected QT interval calculated by the Fridericia formula (QTcF) =< 500 ms within 28 days before registration
  • STEP 2: No intercurrent illness or disease complication that the investigator be

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

Joel NealPrincipal Investigator

Trial Sites

U.S.A.
Arizona
  Scottsdale
 Mayo Clinic Scottsdale
 Helen J Ross Ph: 507-538-7623
California
  Monterey
 Community Hospital of the Monterey Peninsula Comprehensive Cancer Center
 John Hausdorff Ph: 831-625-4753
  Rancho Mirage
 Lucy Curci Cancer Center at Eisenhower Memorial Hospital and Medical Center
 Luke P Dreisbach Ph: 760-834-3798
  Stanford
 Stanford Cancer Center
 Joel W Neal
  Email: ccto-office@stanford.edu
Colorado
  Aurora
 Medical Center of Aurora - South Campus
 Keren Sturtz Ph: 888-785-6789
  Boulder
 Boulder Community Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers-Boulder
 Keren Sturtz Ph: 888-785-6789
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers at the Pavilion
 Keren Sturtz Ph: 888-785-6789
  Denver
 CCOP - Colorado Cancer Research Program
 Keren Sturtz Ph: 888-785-6789
 Colorado Blood Cancer Institute
 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
 Rocky Mountain Cancer Centers - Denver Midtown
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers-Rose
 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
 Keren Sturtz Ph: 888-785-6789
  Englewood
 Comprehensive Cancer Care and Research Institute of Colorado LLC
 Keren Sturtz Ph: 888-785-6789
 Swedish Medical Center
 Keren Sturtz Ph: 888-785-6789
  Golden
 Mountain Blue Cancer Care Center
 Keren Sturtz Ph: 888-785-6789
  Greeley
 North Colorado Medical Center
 Keren Sturtz Ph: 888-785-6789
  Greenwood Village
 Breast Cancer Care Consultants
 Keren Sturtz Ph: 888-785-6789
  Lakewood
 Rocky Mountain Cancer Centers-Lakewood
 Keren Sturtz Ph: 888-785-6789
 St. Anthony Central Hospital
 Keren Sturtz Ph: 888-785-6789
  Lone Tree
 Rocky Mountain Cancer Centers - Lone Tree
 Keren Sturtz Ph: 888-785-6789
 Sky Ridge Medical Center
 Keren Sturtz Ph: 888-785-6789
  Longmont
 Hope Cancer Care Center at Longmont United Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Longmont
 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
 Rocky Mountain Cancer Centers - Parker
 Keren Sturtz Ph: 888-785-6789
  Pueblo
 Rocky Mountain Cancer Centers - Pueblo
 Keren Sturtz Ph: 888-785-6789
 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
 Philip J. Stella Ph: 734-712-3456
Delaware
  Lewes
 Tunnell Cancer Center at Beebe Medical Center
 Gregory A. Masters Ph: 302-733-6227
  Newark
 Helen F. Graham Cancer Center at Christiana Hospital
 Gregory A. Masters Ph: 302-733-6227
  Seaford
 Nanticoke Memorial Hospital
 Gregory A. Masters Ph: 302-733-6227
Georgia
  Atlanta
 Winship Cancer Institute of Emory University
 Suresh Ramalingam Ph: 404-778-1868
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Philip J. Stella Ph: 734-712-3456
Illinois
  Bloomington
 Illinois CancerCare - Bloomington
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 St. Joseph Medical Center
 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
  Decatur
 Decatur Memorial Hospital Cancer Care Institute
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  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
  Moline
 Garneau, Stewart C MD (UIA Investigator)
 David M Spector Ph: 309-779-4200
 Porubcin, Michael MD (UIA Investigator)
 David M Spector Ph: 309-779-4200
 Spector, David MD (UIA Investigator)
 David M Spector Ph: 309-779-4200
 Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
 David M Spector Ph: 309-779-4200
  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
 Illinois CancerCare - Peoria
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Methodist Medical Center of Illinois
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 OSF St. Francis Medical Center
 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
Indiana
  Elkhart
 Elkhart Clinic, LLC
 Jose A. Bufill Ph: 574-237-1328
 Elkhart General Hospital
 Jose A. Bufill Ph: 574-237-1328
 Michiana Hematology-Oncology, PC - Elkhart
 Jose A. Bufill Ph: 574-237-1328
  Indianapolis
 Central Indiana Cancer Centers - East
 Shadia I Jalal Ph: 317-274-2552
 Indiana University Melvin and Bren Simon Cancer Center
 Shadia I Jalal Ph: 317-274-2552
  Kokomo
 Community Cancer Care at Howard Regional Health System
 Jose A. Bufill Ph: 574-237-1328
  La Porte
 Center for Cancer Therapy at LaPorte Hospital and Health Services
 Jose A. Bufill Ph: 574-237-1328
  Mishawaka
 Michiana Hematology-Oncology, PC - Mishawaka
 Jose A. Bufill Ph: 574-237-1328
 Saint Joseph's Medical Center
 Jose A. Bufill Ph: 574-237-1328
  Muncie
 Cancer Center at Ball Memorial Hospital
 William B. Fisher Ph: 765-751-5850
  Email: alpatterson@medicalconsultantspc.com
  Plymouth
 Michiana Hematology Oncology PC - Plymouth
 Jose A. Bufill Ph: 574-237-1328
  South Bend
 CCOP - Northern Indiana CR Consortium
 Jose A. Bufill Ph: 574-237-1328
 Memorial Hospital of South Bend
 Jose A. Bufill Ph: 574-237-1328
 Michiana Hematology-Oncology, PC - South Bend
 Jose A. Bufill Ph: 574-237-1328
 South Bend Clinic
 Jose A. Bufill Ph: 574-237-1328
  Westville
 Michiana Hematology Oncology-PC Westville
 Jose A. Bufill Ph: 574-237-1328
Iowa
  Ames
 McFarland Clinic, PC
 Joseph James Merchant Ph: 515-239-2621
  Bettendorf
 Constantinou, Costas L MD (UIA Investigator)
 David M Spector Ph: 309-779-4200
  Cedar Rapids
 Cedar Rapids Oncology Associates
 Deborah W Wilbur Ph: 319-363-2690
 Deborah W Wilbur Ph: 319-363-2690
 Mercy Regional Cancer Center at Mercy Medical Center
 Deborah W Wilbur Ph: 319-363-2690
  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
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
  Winfield
 Cancer Center of Kansas, PA - Winfield
 Shaker R. Dakhil Ph: 316-262-4467
Maine
  York
 York Hospital's Oncology Treatment Center
 Robert Horowitz Ph: 207-351-3777
Maryland
  Baltimore
 Greater Baltimore Medical Center Cancer Center
 Mei Tang Ph: 443-849-3706
Michigan
  Ann Arbor
 CCOP - Michigan Cancer Research Consortium
 Philip J. Stella Ph: 734-712-3456
 Saint Joseph Mercy Cancer Center
 Philip J. Stella Ph: 734-712-3456
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Philip J. Stella Ph: 734-712-3456
  Detroit
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Philip J. Stella Ph: 734-712-3456
  Escanaba
 Green Bay Oncology, Limited - Escanaba
 Brian L Burnette Ph: 800-432-6049
  Flint
 Genesys Hurley Cancer Institute
 Philip J. Stella Ph: 734-712-3456
 Hurley Medical Center
 Philip J. Stella Ph: 734-712-3456
  Iron Mountain
 Green Bay Oncology - Iron Mountain
 Brian L Burnette Ph: 800-432-6049
  Jackson
 Gayle M. Jacob Cancer Center at Allegiance Health
 Philip J. Stella Ph: 734-712-3456
  Lansing
 Sparrow Regional Cancer Center
 Philip J. Stella Ph: 734-712-3456
  Livonia
 St. Mary Mercy Hospital
 Philip J. Stella Ph: 734-712-3456
  Pontiac
 St. Joseph Mercy Oakland
 Philip J. Stella Ph: 734-712-3456
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Philip J. Stella Ph: 734-712-3456
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Philip J. Stella Ph: 734-712-3456
  Saint Joseph
 Lakeside Cancer Specialists, PLLC
 Jose A. Bufill Ph: 574-237-1328
  St. Joseph
 Lakeland Regional Cancer Care Center - St. Joseph
 Jose A. Bufill Ph: 574-237-1328
  Warren
 St. John Macomb Hospital
 Philip J. Stella Ph: 734-712-3456
Minnesota
  Bemidji
 MeritCare Bemidji
 Preston D. Steen Ph: 701-234-6161
Nevada
  Las Vegas
 CCOP - Nevada Cancer Research Foundation
 John Allan Ellerton Ph: 702-384-0013
New Jersey
  Mount Holly
 Virtua Fox Chase Health Cancer Program at Virtua Memorial Hospital Burlington County
 Michael S. Entmacher Ph: 888-847-8823
  Vineland
 Frank and Edith Scarpa Regional Cancer Pavillion at South Jersey Healthcare
 Carl J. Minniti Ph: 856-641-7933
New York
  Bronx
 Jack D. Weiler Hospital at Montefiore Medical Center - East Campus
 Bilal Piperdi Ph: 718-904-2730
  Email: aecc@aecom.yu.edu
 Montefiore Medical Center
 Bilal Piperdi Ph: 718-904-2730
  Email: aecc@aecom.yu.edu
  White Plains
 Dickstein Cancer Treatment Center at White Plains Hospital Center
 Dan Costin Ph: 914-681-2290
North Dakota
  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
Ohio
  Akron
 Summa Center for Cancer Care at Akron City Hospital
 Jennifer E Payne Ph: 330-375-6101
  Belpre
 Strecker Cancer Center-Belpre
 J. Philip Kuebler Ph: 614-566-3275
  Canton
 Mercy Cancer Center at Mercy Medical Center
 Mitchell Haut Ph: 888-293-4673
  Chillicothe
 Adena Regional Medical Center
 J. Philip Kuebler Ph: 614-566-3275
  Cleveland
 Case Comprehensive Cancer Center
 Afshin Dowlati Ph: 800-641-2422
 MetroHealth Cancer Care Center at MetroHealth Medical Center
 Bruce J. Averbook Ph: 216-778-8526
  Email: kbauchens@metrohealth.org
  Columbus
 CCOP - Columbus
 J. Philip Kuebler Ph: 614-566-3275
 Columbus Oncology Associates, Incorporated
 J. Philip Kuebler Ph: 614-566-3275
 Doctors Hospital at Ohio Health
 J. Philip Kuebler Ph: 614-566-3275
 Grant Medical Center Cancer Care
 J. Philip Kuebler Ph: 614-566-3275
 Mount Carmel Health - West Hospital
 J. Philip Kuebler Ph: 614-566-3275
 Riverside Methodist Hospital Cancer Care
 J. Philip Kuebler Ph: 614-566-3275
 Zangmeister Center
 J. Philip Kuebler Ph: 614-566-3275
  Delaware
 Delaware Health Center
 J. Philip Kuebler Ph: 614-566-3275
 Grady Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Lancaster
 Fairfield Medical Center
 J. Philip Kuebler Ph: 614-566-3275
  Marietta
 Strecker Cancer Center at Marietta Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Mount Vernon
 Knox Community Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Newark
 Licking Memorial Cancer Care Program at Licking Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Portsmouth
 Southern Ohio Medical Center Cancer Center
 J. Philip Kuebler Ph: 614-566-3275
  Springfield
 Community Hospital of Springfield and Clark County
 J. Philip Kuebler Ph: 614-566-3275
  Westerville
 Mount Carmel St. Ann's Cancer Center
 J. Philip Kuebler Ph: 614-566-3275
  Zanesville
 Genesis - Good Samaritan Hospital
 J. Philip Kuebler Ph: 614-566-3275
Pennsylvania
  Bryn Mawr
 Bryn Mawr Hospital
 Albert S DeNittis Ph: 866-225-5654
  Erie
 Regional Cancer Center - Erie
 Jan M. Rothman Ph: 814-838-0448
  Email: mhaynes@trcc.org
  Paoli
 Cancer Center of Paoli Memorial Hospital
 Albert S DeNittis Ph: 866-225-5654
  Sayre
 Guthrie Cancer Center at Guthrie Clinic Sayre
 Bradley W Lash Ph: 800-836-0388
  Wynnewood
 CCOP - Main Line Health
 Albert S DeNittis Ph: 866-225-5654
 Lankenau Cancer Center at Lankenau Hospital
 Albert S DeNittis Ph: 866-225-5654
  York
 WellSpan Health
 Amir Tabatabai Ph: 877-441-7957
South Dakota
  Sioux Falls
 Sanford Cancer Center at Sanford USD Medical Center
 Miroslaw A Mazurczak Ph: 605-328-1367
 Miroslaw A Mazurczak Ph: 605-328-1367
West Virginia
  Morgantown
 Mary Babb Randolph Cancer Center at West Virginia University Hospitals
 Manish Monga Ph: 304-293-2745
  Email: sfilburn@hsc.wvu.edu
Wisconsin
  Chippewa Falls
 Marshfield Clinic - Chippewa Center
 Adedayo Onitilo Ph: 715-393-1400
  Eau Claire
 Center for Cancer Treatment & Prevention at Sacred Heart Hospital
 Adedayo Onitilo Ph: 715-393-1400
 Marshfield Clinic Cancer Care at Regional Cancer Center
 Adedayo Onitilo Ph: 715-393-1400
  Green Bay
 Green Bay Oncology, Limited at St. Mary's Hospital
 Brian L Burnette Ph: 800-432-6049
 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
 Brian L Burnette Ph: 800-432-6049
 St. Mary's Hospital Medical Center - Green Bay
 Brian L Burnette Ph: 800-432-6049
 St. Vincent Hospital Regional Cancer Center
 Brian L Burnette Ph: 800-432-6049
  Manitowoc
 Holy Family Memorial Medical Center Cancer Care Center
 Brian L Burnette Ph: 800-432-6049
  Marinette
 Bay Area Cancer Care Center at Bay Area Medical Center
 Brian L Burnette Ph: 800-432-6049
  Marshfield
 Marshfield Clinic - Marshfield Center
 Adedayo Onitilo Ph: 715-393-1400
 Saint Joseph's Hospital
 Adedayo Onitilo Ph: 715-393-1400
  Milwaukee
 Froedtert Hospital and Medical College of Wisconsin
 Smitha P Menon Ph: 414-805-4380
  Email: jennik@parknicollet.com
  Minocqua
 Marshfield Clinic - Lakeland Center
 Adedayo Onitilo Ph: 715-393-1400
  Oconto Falls
 Green Bay Oncology, Limited - Oconto Falls
 Brian L Burnette Ph: 800-432-6049
  Rhinelander
 Ministry Medical Group at Saint Mary's Hospital
 Adedayo Onitilo Ph: 715-393-1400
 Adedayo Onitilo Ph: 715-393-1400
  Rice Lake
 Marshfield Clinic - Indianhead Center
 Adedayo Onitilo Ph: 715-393-1400
  Sheboygan
 Saint Nicholas Hospital
 Brian L Burnette Ph: 800-432-6049
  Stevens Point
 Marshfield Clinic at Saint Michael's Hospital
 Adedayo Onitilo Ph: 715-393-1400
 Saint Michael's Hospital Cancer Center
 Adedayo Onitilo Ph: 715-393-1400
  Sturgeon Bay
 Green Bay Oncology, Limited - Sturgeon Bay
 Brian L Burnette Ph: 800-432-6049
  Wausau
 Marshfield Clinic - Wausau Center
 Adedayo Onitilo Ph: 715-393-1400
  Weston
 Diagnostic and Treatment Center
 Adedayo Onitilo Ph: 715-393-1400
 Marshfield Clinic - Weston Center
 Adedayo Onitilo Ph: 715-393-1400
 Ministry Saint Clare's Hospital
 Adedayo Onitilo Ph: 715-393-1400
  Wisconsin Rapids
 Marshfield Clinic - Wisconsin Rapids Center
 Adedayo Onitilo Ph: 715-393-1400

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01708954
ClinicalTrials.gov processed this data on April 10, 2014

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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