Eflornithine and/or Sulindac in Preventing Recurrence of High-Risk Adenomas and Second Primary Disease in Patients with Stage 0-III Colon or Rectal Cancer

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase IIIPreventionActive18 and overS0820
NCI-2012-02067, SWOG-S0820, NCT01349881

Trial Description

Summary

This randomized phase III trial studies how well eflornithine works compared to sulindac in preventing the return of the disease (recurrence) of high-risk adenomas and second primary disease in patients with stage 0-III colon or rectal cancer. Drugs used in chemotherapy, such as eflornithine and sulindac, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Further Study Information

PRIMARY OBJECTIVES:

I. To assess whether the combination of eflornithine and sulindac is effective in reducing the three-year event rate (high-risk adenomas and second primary colorectal cancers) in patients with previously treated stage 0-III colon or rectal cancer.

SECONDARY OBJECTIVES:

I. To assess whether the combination of eflornithine and sulindac (compared to corresponding placebos) has efficacy against colorectal lesions with respect to high-grade dysplasia, adenomas with villous features, adenomas 1 cm or greater, multiple adenomas, any adenomas >= 0.3 cm, total advanced colorectal events, or total colorectal events.

II. To assess quantitative and qualitative toxicities of patients when treated with the combination of eflornithine and sulindac compared to corresponding placebos.

III. To evaluate a minimal set of tagging single nucleotide polymorphisms across multiple genes relevant to eflornithine and sulindac, in order to characterize associations with decreased adenoma/second primary colorectal cancer (CRC) risk and adverse events.

IV. To evaluate biomarker responses of treatment effect using novel microfluidics-based digital droplet detection system.

V. To explore the interaction of intervention arm and baseline statin use with respect to the 3-year event rate.

VI. To explore the interaction of the intervention arm and patient-reported meat consumption with respect to the 3-year event rate.

VII. To perform population pharmacokinetic (PK) analysis of eflornithine and sulindac in patients with previously treated stage 0-III colon or rectal cancer.

OUTLINE: Patients are randomized to 1 of 4 treatment arms.

ARM I: Patients receive eflornithine placebo orally (PO) once daily (QD) and sulindac placebo PO QD for 36 months in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive eflornithine PO QD and sulindac placebo PO QD for 36 months in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL PER PROTOCOL DATED 01/27/17)

ARM III: Patients receive eflornithine placebo PO QD and sulindac PO QD for 36 months in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL PER PROTOCOL DATED 01/27/17)

ARM IV: Patients receive eflornithine PO QD and sulindac PO QD for 36 months in the absence of disease progression or unacceptable toxicity.

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

Eligibility Criteria

Inclusion Criteria:

STEP 0: REGISTRATION (Optional)

Patients with a primary colon or rectal cancer resection who are potentially eligible for S0820 may be pre-registered at Step 0; patients registered to Step 0 will appear on an institutional patient tracking report; patients registered to Step 0 are not registered to the S0820 protocol; to participate in S0820, patients must be registered to Step 1 after patient is consented and evaluation of eligibility; patients registered to S0820 at Step 0 continuing to Step 1 registration must use the same Southwest Oncology Group (SWOG) patient identification (ID) for registration to S0820 Step 1

STEP 1: REGISTRATION

Patients must have a history of stage 0, I, II or III colon or rectal adenocarcinoma that has been treated per standard care with resection alone or in combination with radiation or chemotherapy; adjuvant chemotherapy and radiation therapy (RT) treatment must have been completed at least 30 days prior to registration

Patients with history of segmental resections are eligible (i.e. right colectomy, extended right colectomy, transverse colectomy, left colectomy, extended left colectomy, sigmoid colectomy, low anterior resection, abdominoperineal resection); the definition of resection does not include endomucosal resection (EMR); patients that have received total proctocolectomy are ineligible

In addition to segmental resections, the following types of procedures are allowed: polypectomy: for Tis (stage 0) or pT1 patients only, resection may consist entirely of polypectomy (without completion of partial colectomy) if ALL of the following criteria are met:

  • Single specimen, completely removed
  • Clear margins
  • None of the following must be present:

*** Moderate or poor differentiation

*** Lymphovascular invasion

*** Perineural invasion

Transanal excision is allowed for pT1 rectal cancer patients with well or moderately differentiated tumors if National Comprehensive Cancer Network (NCCN) criteria for transanal excision are met, as stipulated here:

  • < 30% circumference of bowel
  • < 3 cm in size
  • Margin clear (> 3 mm)
  • Mobile, nonfixed
  • Within 8cm of anal verge
  • T1 only
  • Endoscopically removed polyp with cancer
  • No lymphovascular invasion or perineural invasion
  • Well to moderately differentiated
  • No evidence of lymphadenopathy on pretreatment imaging

***When the lesion can be adequately identified in the rectum, transanal endoscopic microsurgery (TEM) may be used; TEM for more proximal lesions may be technically feasible

Patients must be registered between 180 days and 465 days (inclusive) of primary resection; patients must show no evidence of disease (NED) based on post-operative colonoscopy (performed at least 180 days after the colon resection date or at least 120 days after the rectal resection date and prior to registration) and computed tomography (CT) scans* of chest, abdomen and pelvis (performed at least 180 days after the colon resection date or at least 120 days after the rectal resection date and prior to registration); patients with adenomas detected at the one-year postoperative colonoscopy are eligible if all adenomas have been completely removed

CT scan is for high risk patients, as per National Comprehensive Cancer Network (NCCN) guidelines and at the discretion of the treating physician

NOTE: magnetic resonance imaging (MRI) evaluation is an acceptable alternative to CT scans for eligibility purposes

Patients must not have cardiovascular risk factors including unstable angina, history of documented myocardial infarction or cerebrovascular accident, coronary artery bypass surgery, or New York Heart Association class III or IV heart failure; patients must not have known uncontrolled hyperlipidemia (defined as low-density lipoprotein cholesterol [LDL-C] >= 190 mg/dL or triglycerides >= 500 mg/dL) within the last 3 years prior to registration or uncontrolled high blood pressure (systolic blood pressure > 150 mm Hg) within 28 days prior to registration

Patients must not have a known history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or inflammatory bowel disease

Patients must have a pure tone audiometry evaluation to document air conduction within 30 days prior to registration; patients with hearing loss > 40 dB in any of the five tested frequencies (250 Hertz [Hz], 500 Hz, 1,000 Hz, 2,000 Hz, 4,000 Hz) are not eligible; patients with active ear infections should be tested only after the acute phase of infection has resolved; for optimal results, it is recommended that testing be conducted by an audiologist, in a hearing test room, with insert earphones; Note: sites should not order audiometry evaluation until the potential participant has met all other eligibility criteria required for this study

Patients must not have known hypersensitivity to eflornithine or sulindac or the excipients byproducts; patients must not have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal antiinflammatory drugs (NSAIDs)

Patients must not have documented history of gastric/duodenal ulcer within the last 12 months; participant must not currently be on treatment for gastric/duodenal ulcer or be experiencing symptoms at study entry; patients with gastroesophageal reflux disease (GERD) are eligible, however, and these patients may receive over-the-counter histamine-2 (H2) antagonists; proton-pump inhibitors, or other prescription-based treatment for GERD

Patients must have a Zubrod performance status of 0-1

Patients must not be expecting to receive radiation or additional chemotherapy

Patients must not be receiving or plan to receive concomitant corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), nor anticoagulants on a regular or predictable intermittent basis; (NSAID use may not exceed 10 days per month); patients may receive daily aspirin for cardiovascular prophylaxis as long as acetylsalicylic acid (ASA) is =< 100 mg per day or =< two 325 mg tablets per week

Patients must have the ability to swallow oral medication

Patients must have no significant medical or psychiatric condition that would preclude study completion; tests and exams for this determination should be completed within 28 days prior to registration

Total white blood cells (WBC) >= 4.0 x 10^3/mcL

Platelets >= 100,000/mcL

Hemoglobin > 11.0 g/dL

Serum bilirubin =< 2.0 mg/dL

Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2 x IULN (institutional upper limit of normal)

Serum creatinine =< 1.5 x IULN obtained within 28 days prior to registration

No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for > 5 years

Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures

SPECIMEN SUBMISSION AND SUBSTUDY CRITERIA

Patients must be offered the option to participate in submission of specimens for banking for future translational medicine studies

Patients participating through PK sites, must be offered the option to submit blood specimens for population pharmacokinetic analysis

Patients must be offered the option to participate in the Diet and Lifestyle Substudy

REGULATORY CRITERIA

Individuals must not currently be participating in any other clinical trial for the treatment or prevention of cancer unless they are no longer receiving the intervention and are in the follow-up phase only; patients must also agree not to join such a trial while participating in this study

All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

As part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

SWOG

  • National Cancer Institute
Jason Adam Zell, Principal Investigator

Trial Sites

U.S.A.

California
Costa Mesa

UC Irvine Health Cancer Center-Newport

Jason Adam Zell
Ph: 877-827-8839
Email: ucstudy@uci.edu

Jason Adam Zell
Principal Investigator

Fresno

University Oncology Associates

Uzair Bashir Chaudhary
Ph: 559-256-9680

Uzair Bashir Chaudhary
Principal Investigator

Orange

Saint Joseph Hospital - Orange

Anita K. Gregory
Ph: 714-734-6220

Anita K. Gregory
Principal Investigator

UC Irvine Health/Chao Family Comprehensive Cancer Center

Jason Adam Zell
Ph: 877-827-8839
Email: ucstudy@uci.edu

Jason Adam Zell
Principal Investigator

Rancho Mirage

Eisenhower Medical Center

Luke Philip Dreisbach
Ph: 800-826-4673
Email: becomingapatient@coh.org

Luke Philip Dreisbach
Principal Investigator

Colorado
Denver

Colorado Cancer Research Program NCORP

Keren Sturtz
Ph: 303-777-2663
Email: kgeisen@co-cancerresearch.org

Keren Sturtz
Principal Investigator

Fort Collins

Poudre Valley Hospital

Steven Robert Schuster
Ph: 855-776-0015

Steven Robert Schuster
Principal Investigator

Connecticut
Derby

Smilow Cancer Hospital-Derby Care Center

Sajid A. Khan
Ph: 203-785-5702

Sajid A. Khan
Principal Investigator

Guilford

Medical Oncology and Hematology Group PC-Guilford

Sajid A. Khan
Ph: 203-785-5702

Sajid A. Khan
Principal Investigator

Hartford

Smilow Cancer Hospital Care Center at Saint Francis

Sajid A. Khan
Ph: 203-785-5702

Sajid A. Khan
Principal Investigator

New Haven

Smilow Cancer Center/Yale-New Haven Hospital

Sajid A. Khan
Ph: 203-785-5702

Sajid A. Khan
Principal Investigator

Yale University

Sajid A. Khan
Ph: 203-785-5702

Sajid A. Khan
Principal Investigator

Orange

Smilow Cancer Hospital-Orange Care Center

Sajid A. Khan
Ph: 203-785-5702

Sajid A. Khan
Principal Investigator

Torrington

Charlotte Hungerford Hospital Center for Cancer Care

Sajid A. Khan
Ph: 203-785-5702

Sajid A. Khan
Principal Investigator

Waterbury

Smilow Cancer Hospital-Waterbury Care Center

Sajid A. Khan
Ph: 203-785-5702

Sajid A. Khan
Principal Investigator

West Haven

Veterans Affairs Connecticut Healthcare System-West Haven Campus

Michal G. Rose
Ph: 203-937-3421ext2832

Michal G. Rose
Principal Investigator

District of Columbia
Washington

Kaiser Permanente-Capitol Hill Medical Center

Leon Christopher Hwang
Ph: 301-816-7218

Leon Christopher Hwang
Principal Investigator

Illinois
Berwyn

Mac Neal Hospital

Irene Q. Ma
Ph: 708-484-8400

Irene Q. Ma
Principal Investigator

Bloomington

Illinois CancerCare-Bloomington

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Saint Joseph Medical Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Canton

Illinois CancerCare-Canton

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Carbondale

Memorial Hospital of Carbondale

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Carterville

SIH Cancer Institute

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Carthage

Illinois CancerCare-Carthage

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Centralia

Centralia Oncology Clinic

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Chicago

Weiss Memorial Hospital

Stuart A. Krauss
Ph: 773-564-5044

Stuart A. Krauss
Principal Investigator

Decatur

Decatur Memorial Hospital

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Effingham

Crossroads Cancer Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Eureka

Illinois CancerCare-Eureka

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Galesburg

Illinois CancerCare-Galesburg

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Western Illinois Cancer Treatment Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Kewanee

Illinois CancerCare-Kewanee Clinic

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Macomb

Illinois CancerCare-Macomb

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Ottawa

Illinois CancerCare-Ottawa Clinic

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Pekin

Illinois CancerCare-Pekin

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Peoria

Illinois CancerCare-Peoria

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Methodist Medical Center of Illinois

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

OSF Saint Francis Medical Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

OSF Saint Francis Radiation Oncology at Peoria Cancer Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Peru

Illinois CancerCare-Peru

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Princeton

Illinois CancerCare-Princeton

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

River Forest

West Suburban Medical Center

Isoken Koko
Ph: 708-488-0882

Isoken Koko
Principal Investigator

Rockford

OSF Saint Anthony Medical Center

Shylendra B. Sreenivasappa
Ph: 815-227-2633

Shylendra B. Sreenivasappa
Principal Investigator

Springfield

Central Illinois Hematology Oncology Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Memorial Medical Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Southern Illinois University School of Medicine

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Springfield Clinic

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Swansea

Cancer Care Specialists of Illinois-Swansea

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Memorial and Saint Elizabeth's Health Care Services LLP

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Indiana
South Bend

Northern Indiana Cancer Research Consortium

Robin T. Zon
Ph: 574-234-5123

Robin T. Zon
Principal Investigator

Iowa
Des Moines

Iowa-Wide Oncology Research Coalition NCORP

Robert J. Behrens
Ph: 515-282-2921

Robert J. Behrens
Principal Investigator

Mason City

Mercy Medical Center - North Iowa

Joginder (Joe) Singh
Ph: 800-433-3883

Joginder (Joe) Singh
Principal Investigator

Kansas
Chanute

Cancer Center of Kansas - Chanute

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Dodge City

Cancer Center of Kansas - Dodge City

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

El Dorado

Cancer Center of Kansas - El Dorado

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Fort Scott

Cancer Center of Kansas - Fort Scott

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Garden City

Saint Catherine Hospital

Peter J. Van Veldhuizen
Ph: 800-525-1483

Peter J. Van Veldhuizen
Principal Investigator

Hays

Hays Medical Center

Stephen K. Williamson
Ph: 913-945-7552
Email: ctnursenav@kumc.edu

Stephen K. Williamson
Principal Investigator

Independence

Cancer Center of Kansas-Independence

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Kansas City

University of Kansas Cancer Center

Stephen K. Williamson
Ph: 913-945-7552
Email: ctnursenav@kumc.edu

Stephen K. Williamson
Principal Investigator

University of Kansas Cancer Center-West

Stephen K. Williamson
Ph: 913-945-7552
Email: ctnursenav@kumc.edu

Stephen K. Williamson
Principal Investigator

Kingman

Cancer Center of Kansas-Kingman

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Lawrence

Lawrence Memorial Hospital

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Liberal

Cancer Center of Kansas-Liberal

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Manhattan

Cancer Center of Kansas-Manhattan

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

McPherson

Cancer Center of Kansas - McPherson

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Newton

Cancer Center of Kansas - Newton

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Olathe

Olathe Medical Center

Stephen K. Williamson
Ph: 913-945-7552
Email: ctnursenav@kumc.edu

Stephen K. Williamson
Principal Investigator

Overland Park

University of Kansas Cancer Center-Overland Park

Stephen K. Williamson
Ph: 913-945-7552
Email: ctnursenav@kumc.edu

Stephen K. Williamson
Principal Investigator

Parsons

Cancer Center of Kansas - Parsons

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Pittsburg

Via Christi Hospital-Pittsburg

Stephen K. Williamson
Ph: 913-945-7552
Email: ctnursenav@kumc.edu

Stephen K. Williamson
Principal Investigator

Pratt

Cancer Center of Kansas - Pratt

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Salina

Cancer Center of Kansas - Salina

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Salina Regional Health Center

Stephen K. Williamson
Ph: 913-945-7552
Email: ctnursenav@kumc.edu

Stephen K. Williamson
Principal Investigator

Topeka

Saint Francis Hospital and Medical Center - Topeka

Stephen K. Williamson
Ph: 913-945-7552
Email: ctnursenav@kumc.edu

Stephen K. Williamson
Principal Investigator

Wellington

Cancer Center of Kansas - Wellington

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Wichita

Associates In Womens Health

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Cancer Center of Kansas - Wichita

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Cancer Center of Kansas-Wichita Medical Arts Tower

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Via Christi Regional Medical Center

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Wichita NCI Community Oncology Research Program

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Winfield

Cancer Center of Kansas - Winfield

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Louisiana
Baton Rouge

Ochsner Health Center-Summa

Burke Jay Brooks
Ph: 225-761-5278

Burke Jay Brooks
Principal Investigator

Kenner

Ochsner Medical Center Kenner

Burke Jay Brooks
Ph: 225-761-5278

Burke Jay Brooks
Principal Investigator

New Orleans

Ochsner Medical Center Jefferson

Burke Jay Brooks
Ph: 225-761-5278

Burke Jay Brooks
Principal Investigator

Maryland
Baltimore

Kaiser Permanente-Woodlawn Medical Center

Leon Christopher Hwang
Ph: 301-816-7218

Leon Christopher Hwang
Principal Investigator

Gaithersburg

Kaiser Permanente-Gaithersburg Medical Center

Leon Christopher Hwang
Ph: 301-816-7218

Leon Christopher Hwang
Principal Investigator

Largo

Kaiser Permanente - Largo Medical Center

Leon Christopher Hwang
Ph: 301-816-7218

Leon Christopher Hwang
Principal Investigator

Michigan
Escanaba

Green Bay Oncology - Escanaba

Matthew L. Ryan
Ph: 920-433-8889

Matthew L. Ryan
Principal Investigator

Minnesota
Saint Louis Park

Metro Minnesota Community Oncology Research Consortium

Patrick James Flynn
Ph: 952-993-1517
Email: mmcorc@parknicollet.com

Patrick James Flynn
Principal Investigator

Missouri
Cape Girardeau

Saint Francis Medical Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Southeast Cancer Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Jefferson City

Capital Region Medical Center-Goldschmidt Cancer Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Kansas City

The University of Kansas Cancer Center-North

Stephen K. Williamson
Ph: 913-945-7552
Email: ctnursenav@kumc.edu

Stephen K. Williamson
Principal Investigator

The University of Kansas Cancer Center-South

Stephen K. Williamson
Ph: 913-945-7552
Email: ctnursenav@kumc.edu

Stephen K. Williamson
Principal Investigator

Truman Medical Center

Stephen K. Williamson
Ph: 913-945-7552
Email: ctnursenav@kumc.edu

Stephen K. Williamson
Principal Investigator

Lee's Summit

The University of Kansas Cancer Center-Lee's Summit

Stephen K. Williamson
Ph: 913-945-7552
Email: ctnursenav@kumc.edu

Stephen K. Williamson
Principal Investigator

Rolla

Delbert Day Cancer Institute at PCRMC

Eric M. Knoche
Ph: 800-600-3606
Email: info@siteman.wustl.edu

Eric M. Knoche
Principal Investigator

Saint Louis

Missouri Baptist Medical Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Sainte Genevieve

Sainte Genevieve County Memorial Hospital

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Sullivan

Missouri Baptist Sullivan Hospital

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Sunset Hills

Missouri Baptist Outpatient Center-Sunset Hills

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Montana
Billings

Montana Cancer Consortium NCORP

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Nebraska
Omaha

Missouri Valley Cancer Consortium

Gamini S. Soori
Ph: 402-398-6060

Gamini S. Soori
Principal Investigator

Nevada
Las Vegas

Nevada Cancer Research Foundation CCOP

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

New York
New York

Laura and Isaac Perlmutter Cancer Center at NYU Langone

Deirdre J. Cohen
Ph: 212-263-4434
Email: prmc.coordinator@nyumc.org

Deirdre J. Cohen
Principal Investigator

North Carolina
Hendersonville

Hendersonville Hematology and Oncology at Pardee

James Earl Radford
Ph: 828-696-4716

James Earl Radford
Principal Investigator

Margaret R Pardee Memorial Hospital

James Earl Radford
Ph: 828-696-4716

James Earl Radford
Principal Investigator

Ohio
WPAFB

Wright-Patterson Medical Center

Susannah Catherine Cooper
Ph: 937-775-1350
Email: som_dcop@wright.edu

Susannah Catherine Cooper
Principal Investigator

Pennsylvania
Bryn Mawr

Bryn Mawr Hospital

Albert S. DeNittis
Ph: 484-476-2649
Email: ewend@mlhs.org

Albert S. DeNittis
Principal Investigator

Media

Riddle Memorial Hospital

Albert S. DeNittis
Ph: 484-476-2649
Email: ewend@mlhs.org

Albert S. DeNittis
Principal Investigator

Paoli

Paoli Memorial Hospital

Albert S. DeNittis
Ph: 484-476-2649
Email: ewend@mlhs.org

Albert S. DeNittis
Principal Investigator

Wynnewood

Lankenau Medical Center

Albert S. DeNittis
Ph: 484-476-2649
Email: ewend@mlhs.org

Albert S. DeNittis
Principal Investigator

Tennessee
Knoxville

University of Tennessee - Knoxville

Wahid T. Hanna
Ph: 865-544-9773

Wahid T. Hanna
Principal Investigator

Texas
San Antonio

University of Texas Health Science Center at San Antonio

Sukeshi Patel Arora
Ph: 210-450-3800

Sukeshi Patel Arora
Principal Investigator

Virginia
Burke

Kaiser Permanente-Burke Medical Center

Leon Christopher Hwang
Ph: 301-816-7218

Leon Christopher Hwang
Principal Investigator

McLean

Kaiser Permanente Tysons Corner Medical Center

Leon Christopher Hwang
Ph: 301-816-7218

Leon Christopher Hwang
Principal Investigator

Washington
Tacoma

Northwest NCI Community Oncology Research Program

John A. Keech
Ph: 253-403-2394

John A. Keech
Principal Investigator

West Virginia
Princeton

Princeton Community Hospital

David Arthur Mullins
Ph: 304-487-7000

David Arthur Mullins
Principal Investigator

Wisconsin
Green Bay

Green Bay Oncology Limited at Saint Mary's Hospital

Matthew L. Ryan
Ph: 920-433-8889

Matthew L. Ryan
Principal Investigator

Saint Vincent Hospital Cancer Center at Saint Mary's

Matthew L. Ryan
Ph: 920-433-8889

Matthew L. Ryan
Principal Investigator

Saint Vincent Hospital Cancer Center Green Bay

Matthew L. Ryan
Ph: 920-433-8889

Matthew L. Ryan
Principal Investigator

Manitowoc

Holy Family Memorial Hospital

Matthew L. Ryan
Ph: 920-433-8889

Matthew L. Ryan
Principal Investigator

Oconto Falls

Green Bay Oncology - Oconto Falls

Matthew L. Ryan
Ph: 920-433-8889

Matthew L. Ryan
Principal Investigator

Sheboygan

HSHS Saint Nicholas Hospital

Matthew L. Ryan
Ph: 920-433-8889

Matthew L. Ryan
Principal Investigator

Sturgeon Bay

Green Bay Oncology - Sturgeon Bay

Matthew L. Ryan
Ph: 920-433-8889

Matthew L. Ryan
Principal Investigator

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Matthew L. Ryan
Ph: 920-433-8889

Matthew L. Ryan
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01349881

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.