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)
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 cancer.
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.
- History of Stage 0-III colon cancer with primary resection 1 year previously
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Patients with rectosigmoid cancers eligible if no RT administered
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One-year post-operative colonoscopy and CT scans of chest, abdomen & pelvis showing no evidence of disease
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Low risk or moderate risk of cardiovascular events
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At least 30 days from completion of adjuvant chemo.
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Presence of gastroesophageal reflux disease acceptable if controlled with medications
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Please contact study team for additional inclusion criteria
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- History of colon resection > 40 cm
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Recurrent or metastatic disease
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- Uncontrolled hypertension
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Planned radiation therapy or additional chemotherapy
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Documented history of gastric/duodenal ulcer within last 12 months and/or current treatment or active symptoms of gastric/duodenal ulcer
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Please contact study team for additional exclusion criteria
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Anti-Inflammatory Agents, Non-Steroidal
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Cyclooxygenase Inhibitors
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Digestive System Diseases
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Digestive System Neoplasms
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Eflornithine/sulindac prevention trial
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Gastrointestinal Diseases
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Gastrointestinal Neoplasms
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Molecular Mechanisms of Pharmacological Action
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Neoplasms by Histologic Type
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Neoplasms, Glandular and Epithelial
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