SWOG clinical trial number
S0820

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)"

Open
Phase
III
Accrual
53%
Abbreviated Title
Adenoma (and Second Primary) Prevention Trial
Activated
03/01/2013
Participants
ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE

Research committees

Prevention & Epidemiology
Gastrointestinal Cancer

Treatment

Placebo Eflornithine Sulindac

Other Study Materials

Eligibility Criteria Expand/Collapse

History of Stage 0, I, II or III colon or rectal cancer; patients must be registered between 120 days and 465 days (inclusive) of primary resection; patients must show no evidence of colorectal cancer based on post-op colonoscopy (performed at least 120 days after the colon or rectal resection date and prior to registration); patients must not have cardiovascular risk factors including unstable angina, history of documented myocardial infarction or cerebrovascular accident, coronary artery bypass surgery or NY Hear Assoc. Class III or IV heart failure; Patients must not have uncontrolled hyperlipidemia (defined as LDL-C >/= 190 mg/dL or triglycerides >/= 500 mg/dL) within the past 3 years prior to registration or uncontrolled high blood pressure (systolic blood pressure > 150 mm Hg) within 28 days prior to registration; adjuvant chemo and RT treatment must have been completed at least 30 days prior to registration; patients must not have a known history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or inflammatory bowel disease, biallelic mismatch repair deficiency syndrome, or constitutional mismatch repair deficiency syndrome; patients with a personal history of large bowel resection > 40 cm are not eligible; patients must not have known hypersensitivity to eflornithine or sulindac; patients must not have documented history of gastric/duodenal ulcer within the last 12 months; patients with gastroesophageal reflux disease are eligible if controlled with medications; patients must have Zubrod PS of 0-1; patients must not be expecting to receive RT or additional chemotherapy; patients must not be receiving or plan to receive concomitant oral or intravenous corticosteroids on a regular basis, nonsteroidal anti-inflammatory drugs (NSAIDs), nor anticoagulants on a regular or predictable intermittent basis; maximum aspirin dose </=100 mg per day or </= two 325 mg tablets per week; inhaled steroids (ie. 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 103/mcL is allowed for non-hispanic black males (NHBM) and total WBC >/= 3.4 x 103/mcL for non-hispanic black females (NHBF); serum bilirubin </= 2.0 mg/dL and AST (SGOT) or ALT (SGPT) </= 2 x IULN, Serum creatinine </= 1.5 x IULN;patients must be 18 years of age or older;CEA for patients who had T2 or greater tumors; 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. After this criteria is met, patients must have pure tone audiomety evaluation to document air conduction within 30 days prior to registration.

Publication Information Expand/Collapse

2017

Updates on S0820/PACES: Preventing adenomas of the colon with eflornithine and sulindac [Review]

J Zell;R Krouse;N You Bulletin of the American College of Surgeons October Volume 102, Issue 10, 2017

2015

SWOG S0820/PACES (Preventing Adenomas of the Colon with Eflornithine and Sulindac), A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial - NCT01349881

J Zell;J Unger;G Anderson;E Cook;J Krouse;P Lance;L Minasian;L Ford;P Brown Journal of Clinical Oncology 33:5s (suppl; abstr TPS3627); American Society of Clinical Oncology Annual Meeting (May 29-June 2, 2015, Chicago, IL), poster session;

Prevention: Tending the gut [Outlook/Opinion; published interview with Dr. J. Zell]

L Gravitz Nature, May 14;521(7551):S6-8

PMid: PMID25970457 | PMC number: not applicable (published interview with Dr. Zell)

PACES trial: Evaluating the effectiveness of eflornithine and sulindac in preventing colon adenomas [Review]

J Zell;N You;J Boughey Bulletin of the American College of Surgeons, Aug;100(8):70-71

PMid: PMID26419059

2013

Challenges of recruiting native Alaskans to a nationwide colorectal cancer prevention study

E Cook;K Anderson;J Zell;P Brown American Society of Preventive Oncology Annual Meeting, poster

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Research Committee(s)
Gastrointestinal Cancer
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Activated
06/15/2016
Open
Phase
III