S0820, Adenoma and Second Primary Prevention Trial (PACES)

  • STATUS
    Recruiting
  • End date
    Feb 1, 2032
  • participants needed
    134
  • sponsor
    Southwest Oncology Group
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Updated on 19 February 2024
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Summary

The investigators hypothesize that the combination of eflornithine and sulindac will be effective in reducing the event rate of adenomas and second primary colorectal cancers at three years in patients previously treated for stage 0 to III colon or rectal cancer.

Description

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.

Details
Condition Colorectal Neoplasms
Age 18 years and older
Treatment Eflornithine placebo & sulindac placebo, eflornithine & sulindac placebo, Eflornithine placebo & sulindac, Eflornithine plus sulindac
Clinical Study IdentifierNCT01349881
SponsorSouthwest Oncology Group
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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
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