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 Cancer, Phase III - Preventing Adenomas of the Colon With Eflornithine and Sulindac (PACES)
Trial status: Open for Enrollment
Why is this study being done?
The purpose of this study is to assess whether eflornithine 500 mg or sulindac 150 mg are effective in reducing the 3-year event rate of high risk adenoma or second primary colorectal cancer in Stage 0, I II and III colon cancer patients. The primary hypothesis will test the main effect of each agent, as well as the comparison of placebo alone to the combination of sulindac and eflornithine.
Who is eligible to participate?
- History of Stage 0-III colon cancer with primary resection 1 year previously
- Patients with rectosigmoid cancers eligible if no RT administered
- One-year post-operative colonoscopy and CT scans of chest, abdomen & pelvis showing no evidence of disease
- Low risk or moderate risk of cardiovascular events
- At least 30 days from completion of adjuvant chemo.
- Presence of gastroesophageal reflux disease acceptable if controlled with medications
- Not receiving or planning to receive concomitant corticosteroids,nonsteroidal anti-inflammatory drugs(NSAIDs), nor anticoagulants. Maximum aspirin dose
- 100 mg per day or ≤ two 325 mg tablets per week.
- Able to swallow oral medications
- Laboratory: WBC ≥ 4.0 x 103/mcL, platelets ≥ 100,000/mcL and hemoglobin > 11.0 g/dL. 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
- 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
- ≥ 20 dB uncorrectable hearing loss for age of any two contiguous 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