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PACES - Colorectal Cancer Prevention

University of North Carolina at Chapel Hill


Description

To assess whether the combination of eflornithine and sulindac is effective in reducing the three-year event rate (high-risk adenomas and second primary colorectal cancers) in patients with previously treated Stage 0-III colon or rectal cancer.


Keywords:

Cancer


Category:

Drug or Biologic
Phase:3

Qualifications

 


Age
18 - 99 years


Gender
Any


Study Population

Colorectal cancer patients (Stage 0, I, II, III) who were previously treated for their cancer per standard care with resection alone or in combination with radiation or chemotherapy.


Investigator

Devena Alston Johnson
Adjunct Associate Professor
Medicine- Oncology

For questions, contact:

Kerry Finch, RN
kerry.finch@unchealth.unc.edu
(252) 962-4140


Recruitment Period End

May 15, 2022

Location

Primary Location
UNC Cancer Care at Nash (Rocky Mount, NC)
Danny Talbott Cancer Center, 2460 Curtis Ellis Dr, Rocky Mount, NC 27804, USA

Study Qualifications

Gender Any

Age Range 18 - 99 years

Participant qualification(s) •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

Not eligible if: •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

Number of Visits

    » approximately 18 visits In person visit(s)

    9 clinic, 4 study drug dispensing, 5 follow-up visits

    » 1 Remote visit(s)

    1 Optional Diet and Lifestyle Questionnaire

Participation Period

8 years total (3 years treatment + 5 years follow-up)

Compensation

By clicking I am interested, your contact information will be sent to the researcher/study coordinator for this study. The coordinator will respond by email with additional information on how to proceed.