Genetic Events Leading to APC-Dependent Colon Cancer in High-Risk Families; a Clinical Trial of COX and EGFR Inhibition in Familial Polyposis Patients

Inclusion Criteria:

- Patients who are 18 years or older with a clinical or genetic diagnosis of FAP or
attenuated FAP.

- Presence of duodenal polyps with a sum of diameters ≥ 5mm.

- Minimum of two weeks since any major surgery

- WHO performance status ≤1

- Adequate bone marrow function as show by: normal leukocyte count, platelet count ≥
120 x 109/L, Hgb > 12 g/dL

- Adequate liver function as shown by: normal serum bilirubin(≤ 1.5 Upper Limit Normal
{ULN}) and serum transaminases (≤ 2.0 ULN)

- Patient must discontinue taking any Nonsteroidal anti-inflammatory drugs (NSAIDS)
within one month of treatment initiation.

- Patients must be able to provide written informed consent.

Exclusion Criteria:

- Prior treatment with any investigational drug within the preceding 4 weeks.

- Malignancies within the past 3 years except for adequately treated carcinoma of the
cervix or basal or squamous cell carcinomas of the skins.

- Patients who have any severe and/or uncontrolled medical conditions or other
conditions that could affect their participation in the study as determined by the
Principle Investigator such as:

1. Unstable angina pectoris, symptomatic congestive heart failure, myocardial
infarction ≤ 6 months prior to first study treatment, serious uncontrolled
cardiac arrhythmia

2. Severely impaired lung function

3. Any active (acute or chronic) or uncontrolled infection/ disorders.

4. Nonmalignant medical illnesses that are uncontrolled or whose control may be
jeopardized by the treatment with the study therapy

5. Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent
hepatitis

- Screening clinical laboratory values that indicate any of the following:

1. anemia

2. thrombocytopenia

3. leucopenia

4. elevations of transaminases greater than 2X ULN

5. elevation of bilirubin > 1.5 X ULN

6. alkaline phosphatase elevation > 1.5 X ULN

7. increased creatinine, urinary protein, or urinary casts outside the clinically
normal range.

- Gastrointestinal bleeding (symptoms including dyspnea, fatigue, angina, weakness,
malaise, melena, hematochezia, hematemesis, anemia or abdominal pain will require
clinical assessment to rule out gastrointestinal bleeding).

- Patient who is currently taking any anti-coagulation medication.

- Women who are pregnant or breast feeding.

- Patients with a known hypersensitivity to sulindac or erlotinib or to their
excipients