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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 University New Orleans, Louisiana  70112-2282
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Hurley Medical Center Flint, Michigan  48503
Sinai Hospital of Baltimore Baltimore, Maryland  21225
Genesys Hurley Cancer Institute Flint, Michigan  48503
Fairview Ridges Hospital Burnsville, Minnesota  55337
Hutchinson Area Health Care Hutchinson, Minnesota  55350
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Sutter Health Western Division Cancer Research Group Greenbrae, California  94904
Methodist Medical Center of Illinois Peoria, Illinois  61636
Memorial Hospital of South Bend South Bend, Indiana  46601
Virginia Mason Medical Center Seattle, Washington  98111
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
University of Kansas Medical Center Kansas City, Kansas  66160-7353
Kaiser Permanente Medical Center - Santa Clara Santa Clara, California  95051-5386
Via Christi Regional Medical Center Wichita, Kansas  67214
Trinity Cancer Care Center Minot, North Dakota  58701
Cancer Center of Kansas - Chanute Chanute, Kansas  66720
Cancer Center of Kansas - Dodge City Dodge City, Kansas  67801
Cancer Center of Kansas - Newton Newton, Kansas  67114
Cancer Center of Kansas - Salina Salina, Kansas  67042
Cancer Center of Kansas - Wellington Wellington, Kansas  67152
Associates in Womens Health Wichita, Kansas  67203
Cancer Center of Kansas - Winfield Winfield, Kansas  67156
Munson Medical Center Traverse City, Michigan  49684
Bozeman Deaconess Hospital Bozeman, Montana  59715
Kalispell Regional Medical Center Kalispell, Montana  59901
Adena Regional Medical Center Chillicothe, Ohio  54601
Grady Memorial Hospital Delaware, Ohio  43015
Fairfield Medical Center Lancaster, Ohio  43130
Welch Cancer Center Sheridan, Wyoming  82801
Elkhart General Hospital Elkhart, Indiana  46515
University Medical Center of Southern Nevada Las Vegas, Nevada  89102
Sutter Solano Medical Center Vallejo, California  94589
Galesburg Clinic Galesburg, Illinois  61401
Proctor Hospital Peoria, Illinois  61614
Salina Regional Health Center Salina, Kansas  67401
Mecosta County Medical Center Big Rapids, Michigan  49307
Grandview Hospital Dayton, Ohio  45405
Mercy Hospital Coon Rapids, Minnesota  55433
Allenmore Hospital Tacoma, Washington  98411-0414
Holy Family Medical Center Des Plaines, Illinois  60016
Saint Joseph Medical Center Joliet, Illinois  60435
Saint Joseph Mercy Hospital Ann Arbor, Michigan  48106
Fairview-Southdale Hospital Edina, Minnesota  55435
Abbott-Northwestern Hospital Minneapolis, Minnesota  55407
Regions Hospital Saint Paul, Minnesota  55101
Saint Francis Regional Medical Center Shakopee, Minnesota  55379
Rice Memorial Hospital Willmar, Minnesota  56201
Alaska Regional Hospital Anchorage, Alaska  99508
Northeast Georgia Medical Center Gainesville, Georgia  30501
Miami Valley Hospital Dayton, Ohio  45409
Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Cancer Center of Kansas - Fort Scott Fort Scott, Kansas  66701
Cancer Center of Kansas-Independence Independence, Kansas  67301
Lawrence Memorial Hospital Lawrence, Kansas  66044
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
Wayne Hospital Greenville, Ohio  45331
Knox Community Hospital Mount Vernon, Ohio  43050
Providence Centralia Hospital Centralia, Washington  98531-9027
Rocky Mountain Oncology Casper, Wyoming  82609
Singing River Hospital Pascagoula, Mississippi  39581
Greene Memorial Hospital Xenia, Ohio  45385
AnMed Health Cancer Center Anderson, South Carolina  29621
Cancer Centers of the Carolinas - Grove Commons Greenville, South Carolina  29605
Cancer Centers of the Carolinas - Seneca Seneca, South Carolina  29672
Cancer Centers of the Carolinas - Spartanburg Spartanburg, South Carolina  29307
Presbyterian Hospital Charlotte, North Carolina  28233-3549
Memorial Medical Center Springfield, Illinois  62781
Queen's Medical Center Honolulu, Hawaii  96813
Kapiolani Medical Center at Pali Momi Aiea, Hawaii  96701
Kapiolani Medical Center for Women and Children Honolulu, Hawaii  96826
Maui Memorial Medical Center Wailuku, Hawaii  96793
Hennepin County Medical Center Minneapolis, Minnesota  
University of Rochester Rochester, New York  14642
Glens Falls Hospital Glens Falls, New York  12801
Saint Alphonsus Regional Medical Center Boise, Idaho  83706
Wayne State University Detroit, Michigan  48202
University of Arizona Health Sciences Center Tucson, Arizona  85724
Straub Clinic and Hospital Honolulu, Hawaii  96813
Riverside Methodist Hospital Columbus, Ohio  43214
Licking Memorial Hospital Newark, Ohio  43055-2899
Cancer Center of Kansas - McPherson McPherson, Kansas  67460
California Pacific Medical Center San Francisco, California  94115
Columbus CCOP Columbus, Ohio  43206
Weiss Memorial Hospital Chicago,, Illinois  60640
Kaiser Permanente Sacramento, California  
University of Kentucky Lexington, Kentucky  40536-0098
Wichita CCOP Wichita, Kansas  67214-3882
Montana Cancer Consortium CCOP Billings, Montana  59101
Virginia Mason CCOP Seattle, Washington  98101
Metro-Minnesota CCOP St. Louis Park, Minnesota  
Lakeview Hospital Stillwater, Minnesota  55082
Decatur Memorial Hospital Decatur, Illinois  62526
Montana Cancer Specialists Missoula, Montana  59807-7877
M D Anderson Cancer Center Houston, Texas  77030
University of Southern California Los Angeles, California  90033
Northern Indiana Cancer Research Consortium South Bend, Indiana  
Hawaii Medical Center East Honolulu, Hawaii  96817
Castle Medical Center Kailua, Hawaii  96734
Hays Medical Center Hays, Kansas  67601
New Ulm Medical Center New Ulm, Minnesota  56073
OSF Saint Francis Medical Center Peoria, Illinois  61637
Mills - Peninsula Hospitals Burlingame, California  94010
Kaiser Permanente, Fremont Fremont, California  94538
Kaiser Permanente, Hayward Hayward, California  94545
Kaiser Permanente-Oakland Oakland, California  94611
Saint Joseph Hospital Orange, California  92868
Kaiser Permanente-Redwood City Redwood City, California  94063
Kaiser Permanente-Richmond Richmond, California  94801
Kaiser Permanente-Roseville Roseville, California  95661
Kaiser Permanente-South Sacramento Sacramento, California  95823
Kaiser Permanente - Sacramento Sacramento, California  95825
Kaiser Permanente-San Francisco San Francisco, California  94115
Kaiser Permanente-Santa Teresa-San Jose San Jose, California  95119
Kaiser Permanente-San Rafael San Rafael, California  94903
Kaiser Permanente-Santa Rosa Santa Rosa, California  95403
Kaiser Permanente-South San Francisco South San Francisco, California  94080
Kaiser Permanente-Stockton Stockton, California  95210
Kaiser Permanente-Vallejo Vallejo, California  94589
Kaiser Permanente-Walnut Creek Walnut Creek, California  94596
Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
Phoebe Putney Memorial Hospital Albany, Georgia  31703
Saint Joseph's-Candler Health System Savannah, Georgia  31405
Oncare Hawaii Inc-POB II Honolulu, Hawaii  96813
Oncare Hawaii Inc-Kuakini Honolulu, Hawaii  96817
University of Hawaii Honolulu, Hawaii  96813
Pacific Cancer Institute of Maui Wailuku, Hawaii  96793
Community Cancer Center Foundation Normal, Illinois  61761
Illinois CancerCare-Ottawa Clinic Ottawa, Illinois  61350
Ottawa Regional Hospital and Healthcare Center Ottawa, Illinois  61350
Pekin Cancer Treatment Center Pekin, Illinois  61554
Illinois Oncology Research Association CCOP Peoria, Illinois  61615
Illinois CancerCare-Peoria Peoria, Illinois  61615
Illinois Valley Hospital Peru, Illinois  61354
Reid Hospital and Health Care Services Richmond, Indiana  47374
Mercy Medical Center-Sioux City Sioux City, Iowa  51104
Saint Luke's Regional Medical Center Sioux City, Iowa  51104
Cancer Center of Kansas - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas-Kingman Kingman, Kansas  67068
Cancer Center of Kansas - Parsons Parsons, Kansas  67357
Cancer Center of Kansas - Pratt Pratt, Kansas  67124
Saint Francis Hospital and Medical Center - Topeka Topeka, Kansas  66606
Cancer Center of Kansas-Wichita Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas - Main Office Wichita, Kansas  67214
Louisiana State University Sciences Center- Monroe Monroe, Louisiana  71210
Highland Clinic Shreveport, Louisiana  71105
Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor, Michigan  48106
Oakwood Hospital Dearborn, Michigan  48123
Saint John Hospital and Medical Center Detroit, Michigan  48236
Grand Rapids Clinical Oncology Program Grand Rapids, Michigan  49503
Saint Mary's Health Care Grand Rapids, Michigan  49503
Spectrum Health at Butterworth Campus Grand Rapids, Michigan  49503
Allegiance Health Jackson, Michigan  49201
Sparrow Hospital Lansing, Michigan  48912
Saint Mary Mercy Hospital Livonia, Michigan  48154
Mercy Health Partners-Mercy Campus Muskegon, Michigan  49443
Saint Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Saint Joseph Mercy Port Huron Port Huron, Michigan  48060
Saint Mary's of Michigan Saginaw, Michigan  48601
Lakeland Hospital St. Joseph, Michigan  49085
Saint John Macomb-Oakland Hospital Warren, Michigan  48093
Unity Hospital Fridley, Minnesota  55432
Saint John's Hospital - Healtheast Maplewood, Minnesota  55109
Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota  55109
North Memorial Medical Health Center Robbinsdale, Minnesota  55422
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota  55416
Minnesota Oncology and Hematology PA-Woodbury Woodbury, Minnesota  55125
Truman Medical Center Kansas City, Missouri  64108
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield Springfield, Missouri  65802
Cox Medical Center Springfield, Missouri  65807
Hematology-Oncology Centers of the Northern Rockies PC Billings, Montana  59101
Saint Vincent Healthcare Billings, Montana  59101
Billings Clinic Billings, Montana  59107-7000
Saint James Community Hospital and Cancer Treatment Center Butte, Montana  59701
Benefis Healthcare- Sletten Cancer Institute Great Falls, Montana  59405
Saint Peter's Community Hospital Helena, Montana  59601
Saint Patrick Hospital - Community Hospital Missoula, Montana  59802
Good Samaritan Hospital Kearney, Nebraska  68847
Nevada Cancer Research Foundation CCOP Las Vegas, Nevada  89106
Wayne Memorial Hospital Goldsboro, North Carolina  27534
Margaret R Pardee Memorial Hospital Hendersonville, North Carolina  28791
Doctors Hospital Columbus, Ohio  43228
Grant Medical Center Columbus, Ohio  43215
Mount Carmel Health Center West Columbus, Ohio  43222
Good Samaritan Hospital - Dayton Dayton, Ohio  45406
Dayton CCOP Dayton, Ohio  45429
Samaritan North Health Center Dayton, Ohio  45415
Blanchard Valley Hospital Findlay, Ohio  45840
Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio  45005-1066
Kettering Medical Center Kettering, Ohio  45429
Marietta Memorial Hospital Marietta, Ohio  45750
Upper Valley Medical Center Troy, Ohio  45373
Saint Ann's Hospital Westerville, Ohio  43081
Genesis HealthCare System Zanesville, Ohio  43701
Greenville CCOP Greenville, South Carolina  29615
Greenville Memorial Hospital Greenville, South Carolina  29605
Upstate Carolina CCOP Spartanburg, South Carolina  29303
Auburn Regional Medical Center Auburn, Washington  98002
Saint Francis Hospital Federal Way, Washington  98003
Providence - Saint Peter Hospital Olympia, Washington  98506-5166
Good Samaritan Community Hospital Puyallup, Washington  98372
Northwest CCOP Tacoma, Washington  98405
Multicare Health System Tacoma, Washington  98415
Saint Clare Hospital Tacoma, Washington  98499
Saint Joseph Medical Center Tacoma, Washington  98405
University of California Medical Center At Irvine-Orange Campus Orange, California  92868
Kansas City Cancer Centers - North Kansas City, Missouri  64154
Elkhart Clinic Elkhart, Indiana  46515
University of Colorado Cancer Center - Anschutz Cancer Pavilion Aurora, Colorado  80045
Denver Veterans Administration Medical Center Denver, Colorado  80220
Illinois CancerCare-Bloomington Bloomington%, Illinois  61701
Illinois CancerCare-Canton Canton, Illinois  61520
Illinois CancerCare-Carthage Carthage, Illinois  62321
Illinois CancerCare-Eureka Eureka, Illinois  61530
Illinois CancerCare-Kewanee Clinic Kewanee, Illinois  61443
Illinois CancerCare-Macomb Macomb, Illinois  61455
Illinois CancerCare-Monmouth Monmouth, Illinois  61462
Illinois CancerCare-Pekin Pekin, Illinois  61603
Illinois CancerCare-Peru Peru, Illinois  61354
Illinois CancerCare-Princeton Princeton, Illinois  61356
Michiana Hematology Oncology PC-Elkhart Elkhart, Indiana  46514
Michiana Hematology Oncology PC-Plymouth Plymouth, Indiana  46563
Michiana Hematology Oncology PC-South Bend South Bend, Indiana  46601
Michiana Hematology Oncology-PC Westville Westville, Indiana  46391
Cancer Center of Kansas-Liberal Liberal, Kansas  67901
Cancer Centers of the Carolinas - Faris Greenville, South Carolina  29605
Cancer Centers of the Carolinas-Greer Medical Oncology Greer, South Carolina  29650
University of Tennessee - Knoxville Knoxville, Tennessee  37920
Kansas City Cancer Centers-Southwest Overland Park, Kansas  66210
Arizona Cancer Center at University Medical Center North Tucson, Arizona  85719
Arizona Cancer Center at UMC Orange Grove Tucson, Arizona  85704
Kaiser Permanente-Deer Valley Medical Center Antioch, California  94531
Kaiser Permanente Medical Center-Vacaville Vacaville, California  95688
Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii  96819
Wilcox Memorial Hospital and Kauai Medical Clinic Lihue, Hawaii  96766-1099
Saint Joseph Regional Medical Center Lewiston, Idaho  83501
Kansas City Cancer Center-West Kansas City, Kansas  66112
Kansas City Cancer Center-Shawnee Mission Shawnee Mission, Kansas  66204
Kansas City Cancer Center - South Kansas City, Missouri  64131
Kansas City Cancer Center-Lee's Summit Lee's Summit, Missouri  64064
The Mark H Zangmeister Center Columbus, Ohio  43219
Southern Ohio Medical Center Portsmouth, Ohio  45662
Saint Francis Hospital Greenville, South Carolina  29601
Overlake Hospital Medical Center Bellevue, Washington  98004
Providence Regional Cancer Partnership Everett, Washington  98201
Pacific Medical Center-First Hill Seattle, Washington  98104
Fairbanks Memorial Hospital Fairbanks, Alaska  99701
Los Angeles County-USC Medical Center Los Angeles, California  90033
Siouxland Hematology Oncology Associates Sioux City, Iowa  51101
Alta Bates Summit Medical Center-Herrick Campus Berkeley, California  94704
Michiana Hematology Oncology PC-Mishawaka Mishawaka, Indiana  46545-1470
Marie Yeager Cancer Center Saint Joseph, Michigan  49085
Franciscan St. Francis Health Indianapolis, Indiana  46237
Southwest Oncology Group San Antonio, Texas  78245
Sanford Bismarck Medical Center Bismarck, North Dakota  58501
Community Howard Regional Health Kokomo, Indiana  46904
Indiana University Health La Porte Hospital La Porte, Indiana  46350
Saint Joseph Regional Medical Center-Mishawaka Mishawaka, Indiana  46545-1470
Via Christi Hospital-Pittsburg Pittsburg, Kansas  66762
Bronson Battle Creek Battle Creek, Michigan  49017
Springfield Regional Medical Center Springfield, Ohio  45505
Promise Regional Medical Center-Hutchinson Hutchinson, Kansas  65702
Sutter Pacific Medical Foundation Santa Rosa, California  95403
Park Ridge Hospital Breast Health Center Hendersonville, North Carolina  28792
OnCare Hawaii-Liliha Honolulu, Hawaii  96817-3169
Saint Rose Ambulatory and Surgery Center Great Bend, Kansas  67530
Cancer Center of Western Wisconsin New Richmond, Wisconsin  54017
Hines Veterans Administration Hospital Hines, Illinois  60141
Kaiser Permanente-Modesto Modesto, California  95356