Ensayos clínicos

Inclusion Criteria:

• 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

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
• ≥ 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