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Clinical Trial ECOGGIS0820

Title

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)

Principal Investigator(s)

Emily Chan

Details

  • Protocol No. ECOGGIS0820
  • Open Date: 09/03/2013
  • Staging: Phase III
  • Age Group: Adults
  • Scope: National
  • Objective: To assess whether eflornithine (+/- sulindac), sulindac (+/- eflornithine) or the combination are effective in reducing the three-year event rate (high-risk adenomas and second primary colorectal cancers) in patients with previously treated Stage 0-III colon cancer.
  • Disease Sites: Colon; Rectal
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Eflornithine; Sulindac
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01349881
  • Secondary Protocol No: S0820

Description

Participants are being asked to take part in this research study because they had a history of Stage 0, I, II, or III colon cancer that has been treated with surgery alone or in combination with chemotherapy. The purpose of this study is to find out if eflornithine and sulindac, taken alone or in combination, can decrease the risk of high-risk adenomas or second primary colorectal cancers in patients who have been treated for Stage 0, I, II, or III colon cancer. The study drugs eflornithine and sulindac are tablets which are taken orally. Sulindac is commercially available but is not approved for this indication. Oral eflornithine is an investigational agent and not approved by the FDA. About 1,488 people will take part in this study; about 21 of them will be at Vanderbilt.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

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