S0820, Adenoma and Second Primary Prevention Trial

• Status: Recruiting
• Trial end date: 2029-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborators: Cancer Prevention Pharmaceuticals, Inc.; National Cancer Institute (NCI)
• Treatments: Eflornithine; Sulindac

Criteria

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