S0820, Adenoma and Second Primary Prevention Trial



Status:Recruiting
Conditions:Colorectal Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/23/2018
Start Date:March 2013
End Date:July 2029
Contact:Patricia N. O'Kane, B.S.
Email:pokane@swog.org
Phone:210-614-8808

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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 or Rectal Cancer, Phase III - Preventing Adenomas of the Colon With Eflornithine and Sulindac (PACES)

The investigators hypothesize that the combination of eflornithine and sulindac will be
effective in reducing a three-year event rate of adenomas and second primary colorectal
cancers in patients previously treated for Stages 0 through III colon or rectal cancer.

The purpose of this study is to assess whether the combination of eflornithine 500 mg and
sulindac 150 mg (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.

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
We found this trial at
948
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Elkton, Maryland 21921
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
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Phone: 505-925-0366
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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2545 Schoenersville Rd
Bethlehem, Pennsylvania 18017
(484) 884-2200
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Lehigh Valley Hospital - Muhlenberg At Lehigh Valley Health Network, we continually go the extra...
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Bremerton, Washington 98310
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1 South Prospect Street
Burlington, Vermont 05401
802-656-8990
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3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Principal Investigator: James W. Fleshman
Phone: 800-422-9567
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
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City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
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Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
(210) 916-4141
Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Louis V. Puneky
Phone: 601-815-6700
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
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Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
Principal Investigator: Kathleen J. Yost
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West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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1800 West Charleston Boulevard
Las Vegas, Nevada 89102
(702) 383-2000
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University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
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Phone: 501-686-8274
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
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Phone: 503-215-2614
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
Principal Investigator: Sukeshi P. Arora
Phone: 210-450-3800
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Seattle, Washington 98104
Principal Investigator: Gary E. Goodman
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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601 South Sherman Street
Spokane, Washington 99202
(509) 228-1000
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808 North 39th Avenue
Yakima, Washington 98902
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98-1079 Moanalua Road
'Aiea, Hawaii 96701
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Aberdeen, Washington 98520
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Abilene, Texas 79601
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
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818 Riverside Ave.
Adrian, Michigan 49221
(517) 265-0900
Bixby Medical Center ProMedica's Mission is to improve your health and well-being. Which is why,...
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Adrian, Michigan 49221
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Albany, Georgia 31701
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Albuquerque, New Mexico 87110
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Allentown, Pennsylvania 18103
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Anaconda, Montana 59711
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Anacortes, Washington 98221
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Anaheim, California 92806
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
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Anchorage, Alaska 98508
Principal Investigator: Gary E. Goodman
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2000 E Greenville St
Anderson, South Carolina 29621
(864) 512-4640
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Phone: 800-486-5941
AnMedical Health Cancer Center Cancer is the general term for a group of more than...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
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5301 McAuley Drive
Ann Arbor, Michigan 48197
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Ann Arbor, Michigan 48106
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Antigo, Wisconsin 54409
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Antioch, California 94531
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Auburn, California 95603
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Aurora, Colorado 80012
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1501 S Potomac St
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(303) 695-2600
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Phone: 888-785-6789
Medical Center of Aurora At The Medical Center of Aurora and Centennial Medical Plaza patients...
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
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Bainbridge Island, Washington 98110
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3325 Pocahontas Road
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Baldwin Park, California 91706
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Baltimore, Maryland 21244
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2401 W Belvedere Ave
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22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
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University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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4305 New Shepherdsville Road
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Baton Rouge, Louisiana 70809
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Baton Rouge, Louisiana 70809
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Baton Rouge, Louisiana 70809
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Baton Rouge, Louisiana 70805
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Baton Rouge, Louisiana 70816
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4950 Essen Lane
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265 Fremont St
Battle Creek, Michigan 49017
(269) 245-8166
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Bronson Battle Creek As a proud member of the Battle Creek community, we believe everyone...
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Bay City, Michigan 48706
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Beachwood, Ohio 44122
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Beaufort, South Carolina 29902
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3535 Pentagon Boulevard
Beavercreek, Ohio 45431
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Bel Air, Maryland 21014
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Bellevue, Washington 98004
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Bellflower, California 90706
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Belmont, North Carolina 28012
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Phone: 704-834-2932
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800 Farson Street
Belpre, Ohio 45714
(740) 401-0417
Principal Investigator: Timothy D. Moore
Phone: 800-523-3977
Strecker Cancer Center-Belpre The Memorial Health System's Strecker Cancer Center, Belpre combines the clinical expertise...
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1300 Anne Street NW
Bemidji, Minnesota 56601
(218) 751-5430
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Sanford Clinic North-Bemidgi Sanford Health is a voluntary, not-for-profit health care organization. Through its entities,...
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Bend, Oregon 97701
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Berkeley, California 94704
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Berlin, Vermont 05602
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Berwyn, Illinois 60402
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Beverly, Massachusetts 01915
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Big Rapids, Michigan 49307
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Billings, Montana 59101
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1233 North 30th Street
Billings, Montana 59101
406-237-7000
Principal Investigator: Benjamin T. Marchello
Phone: 800-648-6274
Saint Vincent Healthcare The Sisters of Charity of Leavenworth, Kansas, founded St. Vincent Healthcare in...
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Billings, Montana 59102
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Billings, Montana 59101
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300 N. Seventh St.
Bismarck, North Dakota 58501
(701) 323-6000
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1505 Eastland Drive
Bloomington, Illinois 61701
309-662-2102
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Phone: 309-243-3605
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Bloomington, Illinois 61701
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Phone: 800-793-2262
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100 E Idaho St
Boise, Idaho 83712
(208) 381-2711
Principal Investigator: Gary E. Goodman
Phone: 907-212-6871
Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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Boise, Idaho 83706
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Bonne Terre, Missouri 63628
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1100 Balsam Ave
Boulder, Colorado 80304
(303) 440-2273
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Boulder, Colorado 80303
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960 W Wooster St
Bowling Green, Ohio 43402
419-353-5419
Toledo Clinic Cancer Centers-Bowling Green Our doctors evaluate and make recommendations regarding cancer treatment for...
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