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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

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Trial Conditions
  • Colorectal Neoplasms
What is the purpose of this trial?

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.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

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

Gender: Both
Steward Physician(s)
  • Jason A. Zell, D.O., MPH
Facilities
  • St. Elizabeth's Medical Center - Active, not recruiting
Trial Interventions
Drug
  • Eflornithine placebo & sulindac placebo
  • eflornithine & sulindac placebo
  • Eflornithine placebo & sulindac
  • Eflornithine plus sulindac
Physician Researcher

Investigator Name:

  • Jason A. Zell, D.O., MPH

Other Information

Sponsor: Southwest Oncology Group
Phase: Phase 3
Trial ID: NCT01349881
Volunteers:  Not Accepting Healthy Volunteers

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