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A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients With Stage 0-III Colon Cancer, Phase III - Preventing Adenomas of the Colon With Eflornithine and Sulindac (PACES)


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Colorectal Neoplasms

Thank you

Trial Information

A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients With Stage 0-III Colon Cancer, Phase III - Preventing Adenomas of the Colon With Eflornithine and Sulindac (PACES)


The purpose of this study is to assess whether eflornithine 500 mg or sulindac 150 mg are
effective in reducing the 3-year event rate of high risk adenoma or second primary
colorectal cancer in Stage 0, I II and III colon cancer patients. The primary hypothesis
will test the main effect of each agent, as well as the comparison of placebo alone to the
combination of sulindac and eflornithine.


Inclusion Criteria:



- History of Stage 0-III colon cancer with primary resection 1 year previously

- Patients with rectosigmoid cancers eligible if no RT administered

- One-year post-operative colonoscopy and CT scans of chest, abdomen & pelvis showing
no evidence of disease

- Low risk or moderate risk of cardiovascular events

- At least 30 days from completion of adjuvant chemo.

- Presence of gastroesophageal reflux disease acceptable if controlled with medications

- Not receiving or planning to receive concomitant corticosteroids,nonsteroidal
anti-inflammatory drugs(NSAIDs), nor anticoagulants. Maximum aspirin dose

- 100 mg per day or ≤ two 325 mg tablets per week.

- Able to swallow oral medications

- Laboratory: WBC ≥ 4.0 x 103/mcL, platelets ≥ 100,000/mcL and hemoglobin > 11.0 g/dL.
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

- ≥ 20 dB uncorrectable hearing loss for age of any two contiguous 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

3-year event rate after registration among Stage 0-III colon cancer patients. (An event is defined as high-risk adenoma or second primary colorectal cancer.)

Outcome Description:

The primary objective is to assess whether eflornithine 500 mg or sulindac 150 mg are effective in reducing the 3-year event rate, defined as high risk adenoma or 2nd primary colorectal cancer, in Stage 0, I, II, and III colon cancer patients.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Jason A. Zell, D.O., MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Irvine

Authority:

United States: Food and Drug Administration

Study ID:

S0820

NCT ID:

NCT01349881

Start Date:

March 2013

Completion Date:

July 2019

Related Keywords:

  • Colorectal Neoplasms
  • Eflornithine/sulindac prevention trial
  • Adenoma
  • Neoplasms
  • Colorectal Neoplasms

Name

Location

Louisiana State UniversityNew Orleans, Louisiana  70112-2282
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Hurley Medical CenterFlint, Michigan  48503
Sinai Hospital of BaltimoreBaltimore, Maryland  21225
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Fairview Ridges HospitalBurnsville, Minnesota  55337
Hutchinson Area Health CareHutchinson, Minnesota  55350
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Sutter Health Western Division Cancer Research GroupGreenbrae, California  94904
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Memorial Hospital of South BendSouth Bend, Indiana  46601
Virginia Mason Medical CenterSeattle, Washington  98111
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Kaiser Permanente Medical Center - Santa ClaraSanta Clara, California  95051-5386
Via Christi Regional Medical CenterWichita, Kansas  67214
Trinity Cancer Care CenterMinot, North Dakota  58701
Cancer Center of Kansas - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas - NewtonNewton, Kansas  67114
Cancer Center of Kansas - SalinaSalina, Kansas  67042
Cancer Center of Kansas - WellingtonWellington, Kansas  67152
Associates in Womens HealthWichita, Kansas  67203
Cancer Center of Kansas - WinfieldWinfield, Kansas  67156
Munson Medical CenterTraverse City, Michigan  49684
Bozeman Deaconess HospitalBozeman, Montana  59715
Kalispell Regional Medical CenterKalispell, Montana  59901
Adena Regional Medical CenterChillicothe, Ohio  54601
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Welch Cancer CenterSheridan, Wyoming  82801
Elkhart General HospitalElkhart, Indiana  46515
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Sutter Solano Medical CenterVallejo, California  94589
Galesburg ClinicGalesburg, Illinois  61401
Proctor HospitalPeoria, Illinois  61614
Salina Regional Health CenterSalina, Kansas  67401
Mecosta County Medical CenterBig Rapids, Michigan  49307
Grandview HospitalDayton, Ohio  45405
Mercy HospitalCoon Rapids, Minnesota  55433
Allenmore HospitalTacoma, Washington  98411-0414
Holy Family Medical CenterDes Plaines, Illinois  60016
Saint Joseph Medical CenterJoliet, Illinois  60435
Saint Joseph Mercy HospitalAnn Arbor, Michigan  48106
Fairview-Southdale HospitalEdina, Minnesota  55435
Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Regions HospitalSaint Paul, Minnesota  55101
Saint Francis Regional Medical CenterShakopee, Minnesota  55379
Rice Memorial HospitalWillmar, Minnesota  56201
Alaska Regional HospitalAnchorage, Alaska  99508
Northeast Georgia Medical CenterGainesville, Georgia  30501
Miami Valley HospitalDayton, Ohio  45409
Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Lawrence Memorial HospitalLawrence, Kansas  66044
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
Wayne HospitalGreenville, Ohio  45331
Knox Community HospitalMount Vernon, Ohio  43050
Providence Centralia HospitalCentralia, Washington  98531-9027
Rocky Mountain OncologyCasper, Wyoming  82609
Singing River HospitalPascagoula, Mississippi  39581
Greene Memorial HospitalXenia, Ohio  45385
AnMed Health Cancer CenterAnderson, South Carolina  29621
Cancer Centers of the Carolinas - Grove CommonsGreenville, South Carolina  29605
Cancer Centers of the Carolinas - SenecaSeneca, South Carolina  29672
Cancer Centers of the Carolinas - SpartanburgSpartanburg, South Carolina  29307
Presbyterian HospitalCharlotte, North Carolina  28233-3549
Memorial Medical CenterSpringfield, Illinois  62781
Queen's Medical CenterHonolulu, Hawaii  96813
Kapiolani Medical Center at Pali MomiAiea, Hawaii  96701
Kapiolani Medical Center for Women and ChildrenHonolulu, Hawaii  96826
Maui Memorial Medical CenterWailuku, Hawaii  96793
Hennepin County Medical CenterMinneapolis, Minnesota  
University of RochesterRochester, New York  14642
Glens Falls HospitalGlens Falls, New York  12801
Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
Wayne State UniversityDetroit, Michigan  48202
University of Arizona Health Sciences CenterTucson, Arizona  85724
Straub Clinic and HospitalHonolulu, Hawaii  96813
Riverside Methodist HospitalColumbus, Ohio  43214
Licking Memorial HospitalNewark, Ohio  43055-2899
Cancer Center of Kansas - McPhersonMcPherson, Kansas  67460
California Pacific Medical CenterSan Francisco, California  94115
Columbus CCOPColumbus, Ohio  43206
Weiss Memorial HospitalChicago,, Illinois  60640
Kaiser PermanenteSacramento, California  
University of KentuckyLexington, Kentucky  40536-0098
Wichita CCOPWichita, Kansas  67214-3882
Montana Cancer Consortium CCOPBillings, Montana  59101
Virginia Mason CCOPSeattle, Washington  98101
Metro-Minnesota CCOPSt. Louis Park, Minnesota  
Lakeview HospitalStillwater, Minnesota  55082
Decatur Memorial HospitalDecatur, Illinois  62526
Montana Cancer SpecialistsMissoula, Montana  59807-7877
M D Anderson Cancer CenterHouston, Texas  77030
University of Southern CaliforniaLos Angeles, California  90033
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Hawaii Medical Center EastHonolulu, Hawaii  96817
Castle Medical CenterKailua, Hawaii  96734
Hays Medical CenterHays, Kansas  67601
New Ulm Medical CenterNew Ulm, Minnesota  56073
OSF Saint Francis Medical CenterPeoria, Illinois  61637
Mills - Peninsula HospitalsBurlingame, California  94010
Kaiser Permanente, FremontFremont, California  94538
Kaiser Permanente, HaywardHayward, California  94545
Kaiser Permanente-OaklandOakland, California  94611
Saint Joseph HospitalOrange, California  92868
Kaiser Permanente-Redwood CityRedwood City, California  94063
Kaiser Permanente-RichmondRichmond, California  94801
Kaiser Permanente-RosevilleRoseville, California  95661
Kaiser Permanente-South SacramentoSacramento, California  95823
Kaiser Permanente - SacramentoSacramento, California  95825
Kaiser Permanente-San FranciscoSan Francisco, California  94115
Kaiser Permanente-Santa Teresa-San JoseSan Jose, California  95119
Kaiser Permanente-San RafaelSan Rafael, California  94903
Kaiser Permanente-Santa RosaSanta Rosa, California  95403
Kaiser Permanente-South San FranciscoSouth San Francisco, California  94080
Kaiser Permanente-StocktonStockton, California  95210
Kaiser Permanente-VallejoVallejo, California  94589
Kaiser Permanente-Walnut CreekWalnut Creek, California  94596
Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Phoebe Putney Memorial HospitalAlbany, Georgia  31703
Saint Joseph's-Candler Health SystemSavannah, Georgia  31405
Oncare Hawaii Inc-POB IIHonolulu, Hawaii  96813
Oncare Hawaii Inc-KuakiniHonolulu, Hawaii  96817
University of HawaiiHonolulu, Hawaii  96813
Pacific Cancer Institute of MauiWailuku, Hawaii  96793
Community Cancer Center FoundationNormal, Illinois  61761
Illinois CancerCare-Ottawa ClinicOttawa, Illinois  61350
Ottawa Regional Hospital and Healthcare CenterOttawa, Illinois  61350
Pekin Cancer Treatment CenterPekin, Illinois  61554
Illinois Oncology Research Association CCOPPeoria, Illinois  61615
Illinois CancerCare-PeoriaPeoria, Illinois  61615
Illinois Valley HospitalPeru, Illinois  61354
Reid Hospital and Health Care ServicesRichmond, Indiana  47374
Mercy Medical Center-Sioux CitySioux City, Iowa  51104
Saint Luke's Regional Medical CenterSioux City, Iowa  51104
Cancer Center of Kansas - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas-KingmanKingman, Kansas  67068
Cancer Center of Kansas - ParsonsParsons, Kansas  67357
Cancer Center of Kansas - PrattPratt, Kansas  67124
Saint Francis Hospital and Medical Center - TopekaTopeka, Kansas  66606
Cancer Center of Kansas-Wichita Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas - Main OfficeWichita, Kansas  67214
Louisiana State University Sciences Center- MonroeMonroe, Louisiana  71210
Highland ClinicShreveport, Louisiana  71105
Michigan Cancer Research Consortium Community Clinical Oncology ProgramAnn Arbor, Michigan  48106
Oakwood HospitalDearborn, Michigan  48123
Saint John Hospital and Medical CenterDetroit, Michigan  48236
Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Saint Mary's Health CareGrand Rapids, Michigan  49503
Spectrum Health at Butterworth CampusGrand Rapids, Michigan  49503
Allegiance HealthJackson, Michigan  49201
Sparrow HospitalLansing, Michigan  48912
Saint Mary Mercy HospitalLivonia, Michigan  48154
Mercy Health Partners-Mercy CampusMuskegon, Michigan  49443
Saint Joseph Mercy OaklandPontiac, Michigan  48341-2985
Saint Joseph Mercy Port HuronPort Huron, Michigan  48060
Saint Mary's of MichiganSaginaw, Michigan  48601
Lakeland HospitalSt. Joseph, Michigan  49085
Saint John Macomb-Oakland HospitalWarren, Michigan  48093
Unity HospitalFridley, Minnesota  55432
Saint John's Hospital - HealtheastMaplewood, Minnesota  55109
Minnesota Oncology Hematology PA-MaplewoodMaplewood, Minnesota  55109
North Memorial Medical Health CenterRobbinsdale, Minnesota  55422
Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, Minnesota  55416
Minnesota Oncology and Hematology PA-WoodburyWoodbury, Minnesota  55125
Truman Medical CenterKansas City, Missouri  64108
Ozark Health Ventures LLC dba Cancer Research for The Ozarks SpringfieldSpringfield, Missouri  65802
Cox Medical CenterSpringfield, Missouri  65807
Hematology-Oncology Centers of the Northern Rockies PCBillings, Montana  59101
Saint Vincent HealthcareBillings, Montana  59101
Billings ClinicBillings, Montana  59107-7000
Saint James Community Hospital and Cancer Treatment CenterButte, Montana  59701
Benefis Healthcare- Sletten Cancer InstituteGreat Falls, Montana  59405
Saint Peter's Community HospitalHelena, Montana  59601
Saint Patrick Hospital - Community HospitalMissoula, Montana  59802
Good Samaritan HospitalKearney, Nebraska  68847
Nevada Cancer Research Foundation CCOPLas Vegas, Nevada  89106
Wayne Memorial HospitalGoldsboro, North Carolina  27534
Margaret R Pardee Memorial HospitalHendersonville, North Carolina  28791
Doctors HospitalColumbus, Ohio  43228
Grant Medical CenterColumbus, Ohio  43215
Mount Carmel Health Center WestColumbus, Ohio  43222
Good Samaritan Hospital - DaytonDayton, Ohio  45406
Dayton CCOPDayton, Ohio  45429
Samaritan North Health CenterDayton, Ohio  45415
Blanchard Valley HospitalFindlay, Ohio  45840
Atrium Medical Center-Middletown Regional HospitalFranklin, Ohio  45005-1066
Kettering Medical CenterKettering, Ohio  45429
Marietta Memorial HospitalMarietta, Ohio  45750
Upper Valley Medical CenterTroy, Ohio  45373
Saint Ann's HospitalWesterville, Ohio  43081
Genesis HealthCare SystemZanesville, Ohio  43701
Greenville CCOPGreenville, South Carolina  29615
Greenville Memorial HospitalGreenville, South Carolina  29605
Upstate Carolina CCOPSpartanburg, South Carolina  29303
Auburn Regional Medical CenterAuburn, Washington  98002
Saint Francis HospitalFederal Way, Washington  98003
Providence - Saint Peter HospitalOlympia, Washington  98506-5166
Good Samaritan Community HospitalPuyallup, Washington  98372
Northwest CCOPTacoma, Washington  98405
Multicare Health SystemTacoma, Washington  98415
Saint Clare HospitalTacoma, Washington  98499
Saint Joseph Medical CenterTacoma, Washington  98405
University of California Medical Center At Irvine-Orange CampusOrange, California  92868
Kansas City Cancer Centers - NorthKansas City, Missouri  64154
Elkhart ClinicElkhart, Indiana  46515
University of Colorado Cancer Center - Anschutz Cancer PavilionAurora, Colorado  80045
Denver Veterans Administration Medical CenterDenver, Colorado  80220
Illinois CancerCare-BloomingtonBloomington%, Illinois  61701
Illinois CancerCare-CantonCanton, Illinois  61520
Illinois CancerCare-CarthageCarthage, Illinois  62321
Illinois CancerCare-EurekaEureka, Illinois  61530
Illinois CancerCare-Kewanee ClinicKewanee, Illinois  61443
Illinois CancerCare-MacombMacomb, Illinois  61455
Illinois CancerCare-MonmouthMonmouth, Illinois  61462
Illinois CancerCare-PekinPekin, Illinois  61603
Illinois CancerCare-PeruPeru, Illinois  61354
Illinois CancerCare-PrincetonPrinceton, Illinois  61356
Michiana Hematology Oncology PC-ElkhartElkhart, Indiana  46514
Michiana Hematology Oncology PC-PlymouthPlymouth, Indiana  46563
Michiana Hematology Oncology PC-South BendSouth Bend, Indiana  46601
Michiana Hematology Oncology-PC WestvilleWestville, Indiana  46391
Cancer Center of Kansas-LiberalLiberal, Kansas  67901
Cancer Centers of the Carolinas - FarisGreenville, South Carolina  29605
Cancer Centers of the Carolinas-Greer Medical OncologyGreer, South Carolina  29650
University of Tennessee - KnoxvilleKnoxville, Tennessee  37920
Kansas City Cancer Centers-SouthwestOverland Park, Kansas  66210
Arizona Cancer Center at University Medical Center NorthTucson, Arizona  85719
Arizona Cancer Center at UMC Orange GroveTucson, Arizona  85704
Kaiser Permanente-Deer Valley Medical CenterAntioch, California  94531
Kaiser Permanente Medical Center-VacavilleVacaville, California  95688
Kaiser Permanente Moanalua Medical CenterHonolulu, Hawaii  96819
Wilcox Memorial Hospital and Kauai Medical ClinicLihue, Hawaii  96766-1099
Saint Joseph Regional Medical CenterLewiston, Idaho  83501
Kansas City Cancer Center-WestKansas City, Kansas  66112
Kansas City Cancer Center-Shawnee MissionShawnee Mission, Kansas  66204
Kansas City Cancer Center - SouthKansas City, Missouri  64131
Kansas City Cancer Center-Lee's SummitLee's Summit, Missouri  64064
The Mark H Zangmeister CenterColumbus, Ohio  43219
Southern Ohio Medical CenterPortsmouth, Ohio  45662
Saint Francis HospitalGreenville, South Carolina  29601
Overlake Hospital Medical CenterBellevue, Washington  98004
Providence Regional Cancer PartnershipEverett, Washington  98201
Pacific Medical Center-First HillSeattle, Washington  98104
Fairbanks Memorial HospitalFairbanks, Alaska  99701
Los Angeles County-USC Medical CenterLos Angeles, California  90033
Siouxland Hematology Oncology AssociatesSioux City, Iowa  51101
Alta Bates Summit Medical Center-Herrick CampusBerkeley, California  94704
Michiana Hematology Oncology PC-MishawakaMishawaka, Indiana  46545-1470
Marie Yeager Cancer CenterSaint Joseph, Michigan  49085
Franciscan St. Francis HealthIndianapolis, Indiana  46237
Southwest Oncology GroupSan Antonio, Texas  78245
Sanford Bismarck Medical CenterBismarck, North Dakota  58501
Community Howard Regional HealthKokomo, Indiana  46904
Indiana University Health La Porte HospitalLa Porte, Indiana  46350
Saint Joseph Regional Medical Center-MishawakaMishawaka, Indiana  46545-1470
Via Christi Hospital-PittsburgPittsburg, Kansas  66762
Bronson Battle CreekBattle Creek, Michigan  49017
Springfield Regional Medical CenterSpringfield, Ohio  45505
Promise Regional Medical Center-HutchinsonHutchinson, Kansas  65702
Sutter Pacific Medical FoundationSanta Rosa, California  95403
Park Ridge Hospital Breast Health CenterHendersonville, North Carolina  28792
OnCare Hawaii-LilihaHonolulu, Hawaii  96817-3169
Saint Rose Ambulatory and Surgery CenterGreat Bend, Kansas  67530
Cancer Center of Western WisconsinNew Richmond, Wisconsin  54017
Hines Veterans Administration HospitalHines, Illinois  60141
Kaiser Permanente-ModestoModesto, California  95356