S0820, Adenoma and Second Primary Prevention Trial

Conditions:Colorectal Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:March 2013
End Date:July 2029
Contact:Patricia N. O'Kane, B.S.

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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 or Rectal 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 or rectal 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.

Inclusion Criteria:

- History of Stage 0-III colon or rectal cancer with primary resection 1 year previously

- Post-operative colonoscopy and CT scans of chest, abdomen & pelvis showing no evidence
of disease

- Must not have cardiovascular risk factors including unstable angina, history of
myocardial infarction, or cerebrovascular accident, coronary artery bypass surgery, or
NY Heart Assoc Class III or IV heart failure.

- Patients must not have known uncontrolled hyperlipidemia (defined as LDL-C >/= 190
mg/dL or triglycerides >/= 500 mg/dL within the past 3 years or uncontrolled high
blood pressure (systolic blood pressure > 150 mm Hg) within 28 days prior to

- At least 30 days from completion of adjuvant chemo and RT.

- Presence of gastroesophageal reflux disease acceptable if controlled with medications

- Not receiving or planning to receive concomitant intravenous corticosteroids on a
regular basis,nonsteroidal anti-inflammatory drugs (NSAIDs), nor anticoagulants on a
regular predictable intermittent basis. NSAID use must not exceed 10 days per month;
Maximum aspirin dose

- 100 mg per day or ≤ two 325 mg tablets per week. Inhaled steroids (i.e. for
asthma or related conditions) are allowed.

- Able to swallow oral medications

- Laboratory: WBC ≥ 4.0 x 1000/mcL, platelets ≥ 100,000/mcL and hemoglobin > 11.0 g/dL.
(A total WBC ≥ 3.1 x 1000/mcL is allowed for non-Hispanic black males and total WBC ≥
3.4 x 1000/mcL for non-Hispanic black females. 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

- ≥ 30 dB uncorrectable hearing loss for age of any of the five tested 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
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