S0820, Adenoma and Second Primary Prevention Trial (PACES)
Colorectal Neoplasms
About this trial
This is an interventional prevention trial for Colorectal Neoplasms focused on measuring Eflornithine/sulindac prevention trial
Eligibility Criteria
Inclusion Criteria:
- History of Stage 0-III colon or rectal cancer with primary resection 1 year previously
- Post-operative colonoscopy and CT scans of chest, abdomen & pelvis showing no evidence of disease
- Must not have cardiovascular risk factors including unstable angina, history of myocardial infarction, or cerebrovascular accident, coronary artery bypass surgery, or NY Heart Assoc Class III or IV heart failure.
- Patients must not have known uncontrolled hyperlipidemia (defined as LDL-C >/= 190 mg/dL or triglycerides >/= 500 mg/dL within the past 3 years or uncontrolled high blood pressure (systolic blood pressure > 150 mm Hg) within 28 days prior to registration
- At least 30 days from completion of adjuvant chemo and RT.
- Presence of gastroesophageal reflux disease acceptable if controlled with medications
Not receiving or planning to receive concomitant intravenous corticosteroids on a regular basis,nonsteroidal anti-inflammatory drugs (NSAIDs), nor anticoagulants on a regular predictable intermittent basis. NSAID use must not exceed 10 days per month; Maximum aspirin dose
- 100 mg per day or ≤ two 325 mg tablets per week. Inhaled steroids (i.e. for asthma or related conditions) are allowed.
- Able to swallow oral medications
- Laboratory: WBC ≥ 4.0 x 1000/mcL, platelets ≥ 100,000/mcL and hemoglobin > 11.0 g/dL. (A total WBC ≥ 3.1 x 1000/mcL is allowed for non-Hispanic black males and total WBC ≥ 3.4 x 1000/mcL for non-Hispanic black females. Serum bilirubin ≤ 2.0 mg/dL and AST (SGOT) or ALT(SGPT) ≤ 2 x IULN. Serum creatinine ≤ 1.5 x IULN
- Zubrod PS 0-1, 18 years of age or older
- Will not participate in any other clinical trial for the treatment or prevention of cancer unless off protocol treatment, on follow-up phase only
- Offered opportunity to participate in blood specimen banking
Exclusion Criteria:
- History of colon resection > 40 cm
- Mid-low rectal cancer
- Recurrent or metastatic disease
- High cardiovascular risk; Uncontrolled hypertension
- Planned radiation therapy or additional chemotherapy
- Documented history of gastric/duodenal ulcer within last 12 months and/or current treatment or active symptoms of gastric/duodenal ulcer
- Known history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or inflammatory bowel disease
- ≥ 30 dB uncorrectable hearing loss for age of any of the five tested frequencies on prestudy audiogram
- Known hypersensitivity to sulindac or excipient byproducts. Previous asthma, urticaria, or allergic-type reaction to aspirin or other NSAIDs
- Significant medical or psychiatric condition that would preclude study completion (8 years)
- No other prior malignancy except 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
- Pregnant or nursing women. Women/men of reproductive potential must agree to use effective contraception
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- Anchorage Associates in Radiation Medicine
- Alaska Breast Care and Surgery LLC
- Alaska Oncology and Hematology LLC
- Alaska Regional Hospital
- Alaska Women's Cancer Care
- Katmai Oncology Group
- Providence Alaska Medical Center
- Fairbanks Memorial Hospital
- Banner MD Anderson Cancer Center
- Cancer Center at Saint Joseph's
- University of Arizona Cancer Center-Orange Grove Campus
- Banner University Medical Center - Tucson
- University of Arizona Cancer Center-North Campus
- CHI Saint Vincent Cancer Center Hot Springs
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
- University of Arkansas for Medical Sciences
- Highlands Oncology Group - Rogers
- Kaiser Permanente-Anaheim
- Kaiser Permanente-Deer Valley Medical Center
- Mission Hope Medical Oncology - Arroyo Grande
- Sutter Auburn Faith Hospital
- Sutter Cancer Centers Radiation Oncology Services-Auburn
- Kaiser Permanente-Baldwin Park
- Kaiser Permanente-Bellflower
- Alta Bates Summit Medical Center-Herrick Campus
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Mills-Peninsula Medical Center
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park
- East Bay Radiation Oncology Center
- Eden Hospital Medical Center
- Valley Medical Oncology Consultants-Castro Valley
- Enloe Medical Center
- University Oncology Associates
- UC Irvine Health Cancer Center-Newport
- Sutter Davis Hospital
- City of Hope Comprehensive Cancer Center
- Epic Care-Dublin
- Kaiser Permanente Dublin
- Bay Area Breast Surgeons Inc
- Epic Care Partners in Cancer Care
- Kaiser Permanente-Fontana
- Kaiser Permanente-Fremont
- Valley Medical Oncology Consultants-Fremont
- Kaiser Permanente-Fresno
- Kaiser Permanente - Harbor City
- Kaiser Permanente-Irvine
- UC San Diego Moores Cancer Center
- UCI Health Laguna Hills
- Loma Linda University Medical Center
- Veterans Affairs Loma Linda Healthcare System
- Kaiser Permanente Los Angeles Medical Center
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- Kaiser Permanente West Los Angeles
- Cedars Sinai Medical Center
- Contra Costa Regional Medical Center
- Memorial Medical Center
- Kaiser Permanente-Modesto
- El Camino Hospital
- Palo Alto Medical Foundation-Camino Division
- Palo Alto Medical Foundation-Gynecologic Oncology
- Sutter Cancer Research Consortium
- Highland General Hospital
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Tumor Institute
- Hematology and Oncology Associates-Oakland
- Tom K Lee Inc
- Kaiser Permanente-Oakland
- Kaiser Permanente-Ontario
- Saint Joseph Hospital - Orange
- UC Irvine Health/Chao Family Comprehensive Cancer Center
- Palo Alto Medical Foundation Health Care
- Kaiser Permanente - Panorama City
- Keck Medical Center of USC Pasadena
- East Bay Medical Oncology Hematology Medical Associates Inc-Pleasant Hill
- Valley Medical Oncology Consultants
- Eisenhower Medical Center
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Kaiser Permanente-Riverside
- Kaiser Permanente-Roseville
- Sutter Cancer Centers Radiation Oncology Services-Roseville
- Sutter Roseville Medical Center
- Kaiser Permanente Downtown Commons
- Sutter Medical Center Sacramento
- Kaiser Permanente-South Sacramento
- Kaiser Permanente - Sacramento
- Kaiser Permanente-San Diego Mission
- Kaiser Permanente-San Diego Zion
- California Pacific Medical Center-Pacific Campus
- Kaiser Permanente-San Francisco
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente San Leandro
- Pacific Central Coast Health Center-San Luis Obispo
- Kaiser Permanente-San Marcos
- Doctors Medical Center- JC Robinson Regional Cancer Center
- Kaiser Permanente-San Rafael
- Kaiser San Rafael-Gallinas
- Kaiser Permanente Medical Center - Santa Clara
- Palo Alto Medical Foundation-Santa Cruz
- Mission Hope Medical Oncology - Santa Maria
- Kaiser Permanente-Santa Rosa
- Sutter Pacific Medical Foundation
- Kaiser Permanente-South San Francisco
- Kaiser Permanente-Stockton
- Palo Alto Medical Foundation-Sunnyvale
- Sutter Cancer Centers Radiation Oncology Services-Vacaville
- Kaiser Permanente Medical Center-Vacaville
- Kaiser Permanente-Vallejo
- Sutter Solano Medical Center/Cancer Center
- Kaiser Permanente-Walnut Creek
- Epic Care Cyberknife Center
- Presbyterian Intercommunity Hospital
- Kaiser Permanente-Woodland Hills
- Rocky Mountain Cancer Centers-Aurora
- The Medical Center of Aurora
- Rocky Mountain Regional VA Medical Center
- University of Colorado Hospital
- Boulder Community Hospital
- Boulder Community Foothills Hospital
- Rocky Mountain Cancer Centers-Boulder
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- UCHealth Memorial Hospital Central
- Porter Adventist Hospital
- Colorado Blood Cancer Institute
- Presbyterian - Saint Lukes Medical Center - Health One
- Rocky Mountain Cancer Centers-Midtown
- SCL Health Saint Joseph Hospital
- Rocky Mountain Cancer Centers-Rose
- Rose Medical Center
- Mercy Medical Center
- Southwest Oncology PC
- Mountain Blue Cancer Care Center - Swedish
- Swedish Medical Center
- Poudre Valley Hospital
- Mountain Blue Cancer Care Center
- North Colorado Medical Center
- Rocky Mountain Cancer Centers-Greenwood Village
- Rocky Mountain Cancer Centers-Lakewood
- Saint Anthony Hospital
- Rocky Mountain Cancer Centers-Littleton
- Littleton Adventist Hospital
- Rocky Mountain Cancer Centers-Sky Ridge
- Sky Ridge Medical Center
- Longmont United Hospital
- Rocky Mountain Cancer Centers-Longmont
- McKee Medical Center
- Parker Adventist Hospital
- Rocky Mountain Cancer Centers-Parker
- Saint Mary Corwin Medical Center
- Rocky Mountain Cancer Centers - Pueblo
- Rocky Mountain Cancer Centers-Thornton
- SCL Health Lutheran Medical Center
- Bridgeport Hospital
- Smilow Cancer Hospital-Derby Care Center
- Smilow Cancer Hospital Care Center-Fairfield
- Greenwich Hospital
- Smilow Cancer Hospital Care Center at Greenwich
- Smilow Cancer Hospital Care Center - Guiford
- Smilow Cancer Hospital Care Center at Saint Francis
- Middlesex Hospital
- Smilow Cancer Center/Yale-New Haven Hospital
- Yale University
- Yale-New Haven Hospital North Haven Medical Center
- Smilow Cancer Hospital-Orange Care Center
- Stamford Hospital/Bennett Cancer Center
- Smilow Cancer Hospital-Torrington Care Center
- Smilow Cancer Hospital Care Center-Trumbull
- Smilow Cancer Hospital-Waterbury Care Center
- Smilow Cancer Hospital Care Center - Waterford
- Veterans Affairs Connecticut Healthcare System-West Haven Campus
- Beebe Medical Center
- Christiana Gynecologic Oncology LLC
- Delaware Clinical and Laboratory Physicians PA
- Helen F Graham Cancer Center
- Medical Oncology Hematology Consultants PA
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- TidalHealth Nanticoke / Allen Cancer Center
- Christiana Care Health System-Wilmington Hospital
- Kaiser Permanente-Capitol Hill Medical Center
- MedStar Georgetown University Hospital
- MedStar Washington Hospital Center
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- South Florida Baptist Hospital
- Saint Anthony's Hospital Cancer Care Center
- Moffitt Cancer Center
- Phoebe Putney Memorial Hospital
- Emory University Hospital Midtown
- Emory University Hospital/Winship Cancer Institute
- Emory Saint Joseph's Hospital
- John B Amos Cancer Center
- Eisenhower Army Medical Center
- Northeast Georgia Medical Center-Gainesville
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Pali Momi Medical Center
- Hawaii Cancer Care Inc - Waterfront Plaza
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- Hawaii Cancer Care Inc-Liliha
- Queen's Cancer Center - Kuakini
- The Cancer Center of Hawaii-Liliha
- Kaiser Permanente Moanalua Medical Center
- Kapiolani Medical Center for Women and Children
- Tripler Army Medical Center
- Castle Medical Center
- Wilcox Memorial Hospital and Kauai Medical Clinic
- Maui Memorial Medical Center
- Pacific Cancer Institute of Maui
- Saint Alphonsus Cancer Care Center-Boise
- Saint Luke's Cancer Institute - Boise
- Saint Alphonsus Cancer Care Center-Caldwell
- Kootenai Health - Coeur d'Alene
- Walter Knox Memorial Hospital
- Saint Luke's Cancer Institute - Fruitland
- Saint Joseph Regional Medical Center
- Idaho Urologic Institute-Meridian
- Saint Luke's Cancer Institute - Meridian
- Saint Alphonsus Medical Center-Nampa
- Saint Luke's Cancer Institute - Nampa
- Kootenai Clinic Cancer Services - Post Falls
- Kootenai Cancer Clinic
- Saint Luke's Cancer Institute - Twin Falls
- Rush - Copley Medical Center
- Mac Neal Hospital
- Saint Joseph Medical Center
- Illinois CancerCare-Bloomington
- Illinois CancerCare-Canton
- Memorial Hospital of Carbondale
- SIH Cancer Institute
- Illinois CancerCare-Carthage
- Centralia Oncology Clinic
- Rush University Medical Center
- Weiss Memorial Hospital
- UChicago Medicine Comprehensive Cancer Center - Saint Joseph Hospital
- Carle on Vermilion
- Decatur Memorial Hospital
- Carle Physician Group-Effingham
- Crossroads Cancer Center
- Illinois CancerCare-Eureka
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- Northwestern Medicine Cancer Center Delnor
- Ingalls Memorial Hospital
- Edward Hines Jr VA Hospital
- Illinois CancerCare-Kewanee Clinic
- Illinois CancerCare-Macomb
- Carle Physician Group-Mattoon/Charleston
- Loyola University Medical Center
- Holy Family Medical Center
- Illinois CancerCare-Monmouth
- Good Samaritan Regional Health Center
- Carle Cancer Institute Normal
- Cancer Care Center of O'Fallon
- Advocate Christ Medical Center
- Illinois CancerCare-Ottawa Clinic
- Ottawa Regional Hospital and Healthcare Center
- Radiation Oncology of Northern Illinois
- Illinois CancerCare-Pekin
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Proctor Hospital
- Illinois CancerCare-Peoria
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Illinois Valley Hospital
- Valley Radiation Oncology
- Illinois CancerCare-Princeton
- West Suburban Medical Center
- OSF Saint Anthony Medical Center
- Central Illinois Hematology Oncology Center
- Southern Illinois University School of Medicine
- Springfield Clinic
- Memorial Medical Center
- Southwest Illinois Health Services LLP
- Carle Cancer Center
- The Carle Foundation Hospital
- Northwestern Medicine Cancer Center Warrenville
- Rush-Copley Healthcare Center
- Michiana Hematology Oncology PC-Crown Point
- Elkhart Clinic
- Michiana Hematology Oncology PC-Elkhart
- Elkhart General Hospital
- Franciscan Health Indianapolis
- Community Howard Regional Health
- IU Health La Porte Hospital
- Premier Oncology Hematology Associates
- Franciscan Saint Anthony Health-Michigan City
- Woodland Cancer Care Center
- Memorial Regional Cancer Center Day Road
- Michiana Hematology Oncology PC-Mishawaka
- Saint Joseph Regional Medical Center-Mishawaka
- Michiana Hematology Oncology PC-Plymouth
- Reid Health
- Memorial Hospital of South Bend
- Michiana Hematology Oncology PC-South Bend
- Porter Memorial Hospital
- Michiana Hematology Oncology PC-Westville
- University of Iowa Healthcare Cancer Services Quad Cities
- Physicians' Clinic of Iowa PC
- Mercy Hospital
- Oncology Associates at Mercy Medical Center
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Alegent Health Mercy Hospital
- Greater Regional Medical Center
- Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates-Des Moines
- Mercy Medical Center - Des Moines
- Mission Cancer and Blood - Laurel
- Iowa Lutheran Hospital
- University of Iowa/Holden Comprehensive Cancer Center
- Mercy Medical Center - North Iowa
- Siouxland Regional Cancer Center
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- MercyOne Waterloo Cancer Center
- Methodist West Hospital
- Mercy Medical Center-West Lakes
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Newman Regional Health
- Cancer Center of Kansas - Fort Scott
- Saint Catherine Hospital
- Central Care Cancer Center - Great Bend
- Saint Rose Ambulatory and Surgery Center
- HaysMed University of Kansas Health System
- Hutchinson Regional Medical Center
- Cancer Center of Kansas-Independence
- Providence Medical Center
- University of Kansas Cancer Center-West
- University of Kansas Cancer Center
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Kansas Institute of Medicine Cancer and Blood Center
- Minimally Invasive Surgery Hospital
- Cancer Center of Kansas-Liberal
- Cancer Center of Kansas-Manhattan
- Cancer Center of Kansas - McPherson
- Cancer Center of Kansas - Newton
- Olathe Health Cancer Center
- Menorah Medical Center
- University of Kansas Cancer Center-Overland Park
- Saint Luke's South Hospital
- Cancer Center of Kansas - Parsons
- Ascension Via Christi - Pittsburg
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Salina Regional Health Center
- Cotton O'Neil Cancer Center / Stormont Vail Health
- University of Kansas Health System Saint Francis Campus
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Ascension Via Christi Hospitals Wichita
- Cancer Center of Kansas - Wichita
- Cancer Center of Kansas - Winfield
- Flaget Memorial Hospital
- Commonwealth Cancer Center-Corbin
- Oncology Hematology Care Inc-Crestview
- Saint Elizabeth Healthcare Edgewood
- Saint Elizabeth Fort Thomas
- Saint Joseph Radiation Oncology Resource Center
- Saint Joseph Hospital East
- University of Kentucky/Markey Cancer Center
- Saint Joseph London
- Jewish Hospital
- Saints Mary and Elizabeth Hospital
- UofL Health Medical Center Northeast
- Saint Claire Regional Medical Center
- Jewish Hospital Medical Center South
- LSU Health Baton Rouge-North Clinic
- Louisiana Hematology Oncology Associates LLC
- Mary Bird Perkins Cancer Center
- Ochsner Health Center-Summa
- Our Lady of the Lake Physicians Group - Medical Oncology
- Medical Center of Baton Rouge
- Ochsner High Grove
- Mary Bird Perkins Cancer Center - Houma
- Lallie Kemp Regional Medical Center
- Ochsner Medical Center Kenner
- East Jefferson General Hospital
- Ochsner LSU Health Monroe Medical Center
- Louisiana State University Health Science Center
- University Medical Center New Orleans
- Ochsner Medical Center Jefferson
- LSU Health Sciences Center at Shreveport
- Highland Clinic
- Central Maine Medical Center
- University of Maryland/Greenebaum Cancer Center
- Sinai Hospital of Baltimore
- Kaiser Permanente-Woodlawn Medical Center
- UM Upper Chesapeake Medical Center
- UPMC Western Maryland
- Christiana Care - Union Hospital
- Kaiser Permanente-Gaithersburg Medical Center
- Kaiser Permanente - Largo Medical Center
- MedStar Montgomery Medical Center
- Beverly Hospital
- Steward Saint Elizabeth's Medical Center
- Addison Gilbert Hospital
- Boston Veteran's Affairs Medical Center
- Mercy Medical Center
- Bixby Medical Center
- Hickman Cancer Center
- Saint Joseph Mercy Hospital
- University of Michigan Comprehensive Cancer Center
- Bronson Battle Creek
- McLaren Cancer Institute-Bay City
- Spectrum Health Big Rapids Hospital
- Saint Joseph Mercy Brighton
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
- Saint Joseph Mercy Canton
- Trinity Health IHA Medical Group Hematology Oncology - Canton
- Caro Cancer Center
- Saint Joseph Mercy Chelsea
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
- Hematology Oncology Consultants-Clarkston
- Newland Medical Associates-Clarkston
- Beaumont Hospital - Dearborn
- Wayne State University/Karmanos Cancer Institute
- Ascension Saint John Hospital
- Great Lakes Cancer Management Specialists-Doctors Park
- Green Bay Oncology - Escanaba
- Weisberg Cancer Treatment Center
- Beaumont Hospital - Farmington Hills
- Genesee Cancer and Blood Disease Treatment Center
- Genesee Hematology Oncology PC
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- McLaren Cancer Institute-Flint
- Singh and Arora Hematology Oncology PC
- Mercy Health Saint Mary's
- Spectrum Health at Butterworth Campus
- Academic Hematology Oncology Specialists
- Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
- Michigan Breast Specialists-Grosse Pointe Woods
- Green Bay Oncology - Iron Mountain
- Allegiance Health
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- Karmanos Cancer Institute at McLaren Greater Lansing
- Sparrow Hospital
- McLaren Cancer Institute-Lapeer Region
- Hope Cancer Clinic
- Trinity Health Saint Mary Mercy Livonia Hospital
- Great Lakes Cancer Management Specialists-Macomb Medical Campus
- Michigan Breast Specialists-Macomb Township
- Saint Mary's Oncology/Hematology Associates of Marlette
- Mercy Memorial Hospital
- Toledo Clinic Cancer Centers-Monroe
- McLaren Cancer Institute-Macomb
- McLaren Cancer Institute-Central Michigan
- Mercy Health Mercy Campus
- Lakeland Hospital Niles
- McLaren Cancer Institute-Northern Michigan
- 21st Century Oncology-Pontiac
- Hope Cancer Center
- Newland Medical Associates-Pontiac
- Saint Joseph Mercy Oakland
- Lake Huron Medical Center
- Spectrum Health Reed City Hospital
- Great Lakes Cancer Management Specialists-Rochester Hills
- William Beaumont Hospital-Royal Oak
- Ascension Saint Mary's Hospital
- Oncology Hematology Associates of Saginaw Valley PC
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer Center
- Ascension Providence Hospitals - Southfield
- Bhadresh Nayak MD PC-Sterling Heights
- Ascension Saint Joseph Hospital
- Munson Medical Center
- William Beaumont Hospital - Troy
- Advanced Breast Care Center PLLC
- Great Lakes Cancer Management Specialists-Macomb Professional Building
- Macomb Hematology Oncology PC
- Michigan Breast Specialists-Warren
- Saint John Macomb-Oakland Hospital
- Saint Mary's Oncology/Hematology Associates of West Branch
- Metro Health Hospital
- Huron Gastroenterology PC
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
- Riverwood Healthcare Center
- Sanford Joe Lueken Cancer Center
- Essentia Health Saint Joseph's Medical Center
- Fairview Ridges Hospital
- Mercy Hospital
- Essentia Health - Deer River Clinic
- Essentia Health Cancer Center
- Essentia Health Saint Mary's Medical Center
- Miller-Dwan Hospital
- Fairview Southdale Hospital
- Lake Region Healthcare Corporation-Cancer Care
- Unity Hospital
- Essentia Health Hibbing Clinic
- Hutchinson Area Health Care
- Fairview Clinics and Surgery Center Maple Grove
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- Health Partners Inc
- New Ulm Medical Center
- North Memorial Medical Health Center
- Mayo Clinic in Rochester
- Coborn Cancer Center at Saint Cloud Hospital
- Saint Cloud Hospital
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Essentia Health Sandstone
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Essentia Health Virginia Clinic
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Fairview Lakes Medical Center
- The West Clinic - Corinth
- Baptist Cancer Center-Grenada
- University of Mississippi Medical Center
- Baptist Memorial Hospital and Cancer Center-Union County
- Baptist Memorial Hospital and Cancer Center-Oxford
- Singing River Hospital
- The West Clinic - Southaven
- Baptist Memorial Hospital and Cancer Center-Desoto
- Parkland Health Center-Bonne Terre
- Saint Francis Medical Center
- Southeast Cancer Center
- Centerpoint Medical Center LLC
- Capital Region Southwest Campus
- Freeman Health System
- Truman Medical Centers
- Saint Luke's Hospital of Kansas City
- North Kansas City Hospital
- Heartland Hematology and Oncology Associates Incorporated
- Kansas City Veterans Affairs Medical Center
- The University of Kansas Cancer Center-South
- Research Medical Center
- University of Kansas Cancer Center - North
- University of Kansas Cancer Center - Lee's Summit
- Saint Luke's East - Lee's Summit
- Liberty Radiation Oncology Center
- Heartland Regional Medical Center
- Saint Joseph Oncology Inc
- Veteran's Affairs Medical Center - Saint Louis
- Mercy Hospital South
- Missouri Baptist Medical Center
- Siteman Cancer Center at Christian Hospital
- Sainte Genevieve County Memorial Hospital
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Missouri Baptist Sullivan Hospital
- Missouri Baptist Outpatient Center-Sunset Hills
- Community Hospital of Anaconda
- Billings Clinic Cancer Center
- Saint Vincent Healthcare
- Saint Vincent Frontier Cancer Center
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Great Falls Clinic
- Saint Peter's Community Hospital
- Kalispell Regional Medical Center
- Montana Cancer Specialists
- Saint Patrick Hospital - Community Hospital
- Community Medical Hospital
- CHI Health Saint Francis
- Heartland Hematology and Oncology
- CHI Health Good Samaritan
- Nebraska Hematology and Oncology
- Nebraska Cancer Research Center
- Saint Elizabeth Regional Medical Center
- Faith Regional Health Services Carson Cancer Center
- Great Plains Health Callahan Cancer Center
- Missouri Valley Cancer Consortium
- Alegent Health Immanuel Medical Center
- Hematology and Oncology Consultants PC
- Alegent Health Bergan Mercy Medical Center
- Nebraska Cancer Specialists - Omaha
- Alegent Health Lakeside Hospital
- Oncology Hematology West PC
- Urology Cancer Center PC
- Creighton University Medical Center
- Midlands Community Hospital
- Regional West Medical Center Cancer Center
- Cancer and Blood Specialists-Henderson
- Comprehensive Cancer Centers of Nevada - Henderson
- Comprehensive Cancer Centers of Nevada-Horizon Ridge
- Las Vegas Cancer Center-Henderson
- OptumCare Cancer Care at Seven Hills
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
- GenesisCare USA - Henderson
- OptumCare Cancer Care at Charleston
- University Medical Center of Southern Nevada
- Cancer and Blood Specialists-Shadow
- Radiation Oncology Centers of Nevada Central
- GenesisCare USA - Las Vegas
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
- Radiation Oncology Centers of Nevada Southeast
- Cancer Therapy and Integrative Medicine
- Cancer and Blood Specialists-Tenaya
- Comprehensive Cancer Centers of Nevada - Northwest
- GenesisCare USA - Vegas Tenaya
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
- OptumCare Cancer Care at MountainView
- Comprehensive Cancer Centers of Nevada-Summerlin
- Las Vegas Cancer Center-Medical Center
- Comprehensive Cancer Centers of Nevada
- GenesisCare USA - Fort Apache
- OptumCare Cancer Care at Fort Apache
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
- Comprehensive Cancer Centers of Nevada - Central Valley
- New Hampshire Oncology Hematology PA-Concord
- Exeter Hospital
- LRGHealthcare-Lakes Region General Hospital
- Solinsky Center for Cancer Care
- Cooper Hospital University Medical Center
- Morristown Medical Center
- Virtua Memorial
- Inspira Medical Center Mullica Hill
- Chilton Medical Center
- Overlook Hospital
- Community Medical Center
- Inspira Medical Center Vineland
- Virtua Voorhees
- Lovelace Medical Center-Saint Joseph Square
- University of New Mexico Cancer Center
- New Mexico Oncology Hematology Consultants
- Presbyterian Kaseman Hospital
- Presbyterian Rust Medical Center/Jorgensen Cancer Center
- Christus Saint Vincent Regional Cancer Center
- Hematology Oncology Associates of Central New York-Auburn
- Hematology Oncology Associates of Central New York-East Syracuse
- Arnot Ogden Medical Center/Falck Cancer Center
- Glens Falls Hospital
- Northwell Health/Center for Advanced Medicine
- Hematology Oncology Associates of Central New York-Liverpool
- Northern Westchester Hospital
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
- University of Rochester
- Hematology Oncology Associates of Central New York-Rome
- Phelps Memorial Hospital Center
- Stony Brook University Medical Center
- Hematology Oncology Associates of Central New York-Onondaga Hill
- Dickstein Cancer Treatment Center
- Gaston Hematology and Oncology Associates-Belmont
- Novant Health Presbyterian Medical Center
- Novant Health Carolina Surgical - Randolph
- Oncology Specialists of Charlotte
- Southern Oncology Specialists-Charlotte
- Southeastern Medical Oncology Center-Clinton
- CaroMont Regional Medical Center
- Gaston Hematology and Oncology Associates
- Southeastern Medical Oncology Center-Goldsboro
- Wayne Memorial Hospital
- Hendersonville Hematology and Oncology at Pardee
- Margaret R Pardee Memorial Hospital
- AdventHealth Hendersonville
- Novant Health Cancer Institute - Huntersville
- Southern Oncology Specialists-Huntersville
- Southeastern Medical Oncology Center-Jacksonville
- Matthews Radiation Oncology Center
- Novant Health Cancer Institute - Matthews
- Novant Health Cancer Institute - Mooresville
- Nash General Hospital
- Cleveland Hematology and Oncology Associates PC
- Sanford Bismarck Medical Center
- Essentia Health Cancer Center-South University Clinic
- Sanford Broadway Medical Center
- Sanford Clinic North-Fargo
- Sanford Roger Maris Cancer Center
- Altru Cancer Center
- Trinity Cancer Care Center
- Cleveland Clinic Cancer Center Beachwood
- UHHS-Chagrin Highlands Medical Center
- Indu and Raj Soin Medical Center
- Strecker Cancer Center-Belpre
- Toledo Clinic Cancer Centers-Bowling Green
- Cleveland Clinic Mercy Hospital
- Aultman Health Foundation
- Dayton Physicians LLC-Miami Valley South
- Miami Valley Hospital South
- Geauga Hospital
- Adena Regional Medical Center
- Oncology Hematology Care Inc-Eden Park
- Oncology Hematology Care Inc-Mercy West
- The Christ Hospital
- Good Samaritan Hospital - Cincinnati
- Oncology Hematology Care Inc-Anderson
- Oncology Hematology Care Inc-Kenwood
- Bethesda North Hospital
- Oncology Hematology Care Inc-Blue Ash
- TriHealth Cancer Institute-Westside
- TriHealth Cancer Institute-Anderson
- Case Western Reserve University
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- Ohio State University Comprehensive Cancer Center
- Mount Carmel East Hospital
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist Hospital
- Grant Medical Center
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Doctors Hospital
- Grandview Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Dayton Physician LLC-Miami Valley Hospital North
- Miami Valley Hospital North
- Delaware Health Center-Grady Cancer Center
- Delaware Radiation Oncology
- Grady Memorial Hospital
- Columbus Oncology and Hematology Associates
- Dublin Methodist Hospital
- Hematology Oncology Center Incorporated
- Mercy Cancer Center-Elyria
- Oncology Hematology Care Inc-Healthplex
- Armes Family Cancer Center
- Blanchard Valley Hospital
- Orion Cancer Care
- Atrium Medical Center-Middletown Regional Hospital
- Dayton Physicians LLC-Atrium
- Central Ohio Breast and Endocrine Surgery
- Dayton Physicians LLC-Wayne
- Wayne Hospital
- Mount Carmel Grove City Hospital
- Cleveland Clinic Cancer Center Independence
- Greater Dayton Cancer Center
- First Dayton Cancer Care
- Kettering Medical Center
- Fairfield Medical Center
- Lancaster Radiation Oncology
- Saint Rita's Medical Center
- Lima Memorial Hospital
- OhioHealth Mansfield Hospital
- Cleveland Clinic Cancer Center Mansfield
- Marietta Memorial Hospital
- OhioHealth Marion General Hospital
- Toledo Clinic Cancer Centers-Maumee
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
- Hillcrest Hospital Cancer Center
- UH Seidman Cancer Center at Lake Health Mentor Campus
- UH Seidman Cancer Center at Southwest General Hospital
- Dayton Physicians LLC-Signal Point
- Knox Community Hospital
- Licking Memorial Hospital
- Newark Radiation Oncology
- Saint Charles Hospital
- Toledo Clinic Cancer Centers-Oregon
- University Hospitals Parma Medical Center
- Mercy Health Perrysburg Cancer Center
- Southern Ohio Medical Center
- North Coast Cancer Care
- UH Seidman Cancer Center at Firelands Regional Medical Center
- Dayton Physicians LLC-Wilson
- Springfield Regional Cancer Center
- Springfield Regional Medical Center
- Cleveland Clinic Cancer Center Strongsville
- ProMedica Flower Hospital
- Mercy Hospital of Tiffin
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
- Saint Vincent Mercy Medical Center
- University of Toledo
- Toledo Community Hospital Oncology Program CCOP
- Mercy Health - Saint Anne Hospital
- Toledo Clinic Cancer Centers-Toledo
- Dayton Physicians LLC-Upper Valley
- Upper Valley Medical Center
- University Hospitals Sharon Health Center
- South Pointe Hospital
- Fulton County Health Center
- Saint Ann's Hospital
- UH Seidman Cancer Center at Saint John Medical Center
- UHHS-Westlake Medical Center
- Cleveland Clinic Wooster Family Health and Surgery Center
- Wright-Patterson Medical Center
- Greene Memorial Hospital
- Genesis Healthcare System Cancer Care Center
- Cancer Centers of Southwest Oklahoma Research
- University of Oklahoma Health Sciences Center
- Mercy Hospital Oklahoma City
- Saint Alphonsus Medical Center-Baker City
- Saint Charles Health System
- Clackamas Radiation Oncology Center
- Providence Cancer Institute Clackamas Clinic
- Bay Area Hospital
- Providence Newberg Medical Center
- Saint Alphonsus Medical Center-Ontario
- Providence Willamette Falls Medical Center
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Kaiser Permanente Northwest
- Jefferson Abington Hospital
- Lehigh Valley Hospital-Cedar Crest
- Lehigh Valley Hospital - Muhlenberg
- Bryn Mawr Hospital
- Main Line Health Center-Collegeville
- Geisinger Medical Center
- Pocono Medical Center
- Easton Hospital
- Main Line Health Center-Exton
- Geisinger Medical Center-Cancer Center Hazleton
- Lehigh Valley Hospital-Hazleton
- Geisinger Medical Oncology-Lewisburg
- Lewistown Hospital
- Riddle Memorial Hospital
- Paoli Memorial Hospital
- Phoenixville Hospital
- Geisinger Cancer Services-Pottsville
- Community Medical Center
- Geisinger Medical Oncology-Selinsgrove
- Geisinger Medical Group
- Chester County Hospital
- Reading Hospital
- Geisinger Wyoming Valley/Henry Cancer Center
- Asplundh Cancer Pavilion
- Lankenau Medical Center
- AnMed Health Cancer Center
- Beaufort Memorial Hospital
- Saint Joseph's/Candler - Bluffton Campus
- Prisma Health Cancer Institute - Spartanburg
- Roper Hospital
- Charleston Oncology - Roper
- Lowcountry Hematology Oncology PA-North Charleston
- Bon Secours Saint Francis Hospital
- Charleston Oncology - Saint Francis
- Lowcountry Hematology Oncology PA-West Ashley
- Prisma Health Cancer Institute - Easley
- Gibbs Cancer Center-Gaffney
- Greenville Health System Cancer Institute-Andrews
- Saint Francis Hospital
- Prisma Health Cancer Institute - Butternut
- Prisma Health Cancer Institute - Faris
- Prisma Health Greenville Memorial Hospital
- Prisma Health Cancer Institute - Eastside
- Self Regional Healthcare
- Prisma Health Cancer Institute - Greer
- Gibbs Cancer Center-Pelham
- South Carolina Cancer Specialists PC
- Lowcountry Hematology Oncology PA-Mount Pleasant
- Prisma Health Cancer Institute - Seneca
- Spartanburg Medical Center
- MGC Hematology Oncology-Union
- Sanford Cancer Center Oncology Clinic
- Avera Cancer Institute
- Sanford USD Medical Center - Sioux Falls
- Memorial Hospital
- Baptist Memorial Hospital and Cancer Center-Collierville
- The West Clinic - Wolf River
- Pulmonary Medicine Center of Chattanooga-Hixson
- University of Tennessee - Knoxville
- The West Clinic - Mid-Town
- Baptist Memorial Hospital and Cancer Center-Memphis
- University of Tennessee Health Science Center
- Meharry Medical College
- Vanderbilt University/Ingram Cancer Center
- Memorial GYN Plus
- Hendrick Medical Center
- Saint Joseph Regional Cancer Center
- Parkland Memorial Hospital
- Baylor University Medical Center
- UT Southwestern/Simmons Cancer Center-Dallas
- Brooke Army Medical Center
- M D Anderson Cancer Center
- Covenant Medical Center-Lakeside
- Audie L Murphy VA Hospital
- Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
- University Hospital
- University of Texas Health Science Center at San Antonio
- Scott and White Memorial Hospital
- Central Vermont Medical Center/National Life Cancer Treatment
- University of Vermont Medical Center
- University of Vermont and State Agricultural College
- White River Junction Veteran Administration Medical Center
- Kaiser Permanente-Burke Medical Center
- Fredericksburg Oncology Inc
- Sovah Health Martinsville
- Kaiser Permanente Tysons Corner Medical Center
- Providence Regional Cancer System-Aberdeen
- Cancer Care Center at Island Hospital
- MultiCare Auburn Medical Center
- Virginia Mason Bainbridge Island Medical Center
- Overlake Medical Center
- PeaceHealth Saint Joseph Medical Center
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Harrison Medical Center
- Highline Medical Center-Main Campus
- Providence Regional Cancer System-Centralia
- Swedish Cancer Institute-Edmonds
- Saint Elizabeth Hospital
- Providence Regional Cancer Partnership
- Virginia Mason Federal Way Medical Center
- Saint Francis Hospital
- Tacoma/Valley Radiation Oncology Centers-Gig Harbor
- MultiCare Gig Harbor Medical Park
- Swedish Cancer Institute-Issaquah
- Kadlec Clinic Hematology and Oncology
- Northwest Cancer Clinic
- Seattle Cancer Care Alliance at EvergreenHealth
- Providence Regional Cancer System-Lacey
- Saint Clare Hospital
- PeaceHealth Saint John Medical Center
- Virginia Mason Lynnwood Medical Center
- Skagit Valley Hospital
- Providence - Saint Peter Hospital
- Capital Medical Center
- Jefferson Healthcare
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- Peninsula Cancer Center
- MultiCare Good Samaritan Hospital
- Tacoma/Valley Radiation Oncology Centers-Puyallup
- Valley Medical Center
- Virginia Mason Medical Center
- Harborview Medical Center
- Minor and James Medical PLLC
- Pacific Gynecology Specialists
- Pacific Medical Center-First Hill
- Swedish Medical Center-Ballard Campus
- Fred Hutchinson Cancer Research Center
- Kaiser Permanente Washington
- Swedish Medical Center-First Hill
- University of Washington Medical Center - Montlake
- PeaceHealth United General Medical Center
- Providence Regional Cancer System-Shelton
- MultiCare Deaconess Cancer and Blood Specialty Center - Valley
- Cancer Care Northwest - Spokane South
- MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
- Evergreen Hematology and Oncology PS
- MultiCare Deaconess Cancer and Blood Specialty Center - North
- Rockwood Clinic
- Tacoma/Valley Radiation Oncology Centers-Jackson Hall
- Franciscan Research Center-Northwest Medical Plaza
- MultiCare Allenmore Hospital
- MultiCare Tacoma General Hospital
- Northwest Medical Specialties PLLC
- Saint Joseph Medical Center
- Tacoma/Valley Radiation Oncology Centers-Saint Joe's
- PeaceHealth Southwest Medical Center
- Providence Saint Mary Regional Cancer Center
- Wenatchee Valley Hospital and Clinics
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- Providence Regional Cancer System-Yelm
- Saint Mary's Medical Center
- Princeton Community Hospital
- Langlade Hospital and Cancer Center
- Duluth Clinic Ashland
- Marshfield Clinic-Chippewa Center
- Marshfield Clinic Cancer Center at Sacred Heart
- Marshfield Medical Center-EC Cancer Center
- Green Bay Oncology at Saint Vincent Hospital
- Bellin Memorial Hospital
- Saint Vincent Hospital Cancer Center Green Bay
- Green Bay Oncology Limited at Saint Mary's Hospital
- Saint Vincent Hospital Cancer Center at Saint Mary's
- Gundersen Lutheran Medical Center
- Holy Family Memorial Hospital
- Bay Area Medical Center
- Saint Vincent Hospital Cancer Center at Marinette
- Marshfield Medical Center-Marshfield
- Aspirus Medford Hospital
- Marshfield Clinic-Minocqua Center
- Cancer Center of Western Wisconsin
- Saint Vincent Hospital Cancer Center at Oconto Falls
- Ascension Saint Mary's Hospital
- Marshfield Medical Center-Rice Lake
- HSHS Saint Nicholas Hospital
- Ascension Saint Michael's Hospital
- Marshfield Medical Center-River Region at Stevens Point
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
- Green Bay Oncology - Sturgeon Bay
- Aspirus Regional Cancer Center
- Marshfield Clinic-Wausau Center
- Marshfield Medical Center - Weston
- Aspirus Cancer Care - Wisconsin Rapids
- Marshfield Clinic - Wisconsin Rapids Center
- Rocky Mountain Oncology
- Cheyenne Regional Medical Center-West
- Big Horn Basin Cancer Center
- Billings Clinic-Cody
- Welch Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Experimental
Experimental
Experimental
eflornithine placebo & sulindac placebo
Eflornithine & sulindac placebo
Eflornithine placebo & sulindac
Eflornithine plus sulindac
Eflornithine placebo 2 tablets, PO, daily for 3 years. Sulindac placebo, 1 tablet, PO, daily for 3 years.
Eflornithine two 250 mg tablets PO daily for 3 years. Sulindac placebo one tablet PO daily for 3 years.
Eflornithine placebo 2 tablets PO daily for 3 years. Sulindac one 150 mg tablet PO daily for 3 years.
Eflornithine two 250 mg tablets PO daily for 3 years. Sulindac one 150 mg tablet PO daily for 3 years.