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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 III - Preventing Adenomas of the Colon With Eflornithine and Sulindac (PACES)

Phase 3
18 Years
Open (Enrolling)
Colorectal Neoplasms

Thank you

Trial Information

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 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.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

3-year event rate after registration among Stage 0-III colon cancer patients. (An event is defined as high-risk adenoma or second primary colorectal cancer.)

Outcome Description:

The primary objective is to assess whether eflornithine 500 mg or sulindac 150 mg are effective in reducing the 3-year event rate, defined as high risk adenoma or 2nd primary colorectal cancer, in Stage 0, I, II, and III colon cancer patients.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Jason A. Zell, D.O., MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Irvine


United States: Food and Drug Administration

Study ID:




Start Date:

March 2013

Completion Date:

July 2019

Related Keywords:

  • Colorectal Neoplasms
  • Eflornithine/sulindac prevention trial
  • Adenoma
  • Neoplasms
  • Colorectal Neoplasms



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