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 Principal Investigator such as:
• Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤ 6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia
• Severely impaired lung function
• Any active (acute or chronic) or uncontrolled infection/ disorders.
• Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy
• Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
• Screening clinical laboratory values that indicate any of the following:
• anemia
• thrombocytopenia
• leucopenia
• elevations of transaminases greater than 2X ULN
• elevation of bilirubin > 1.5 X ULN
• alkaline phosphatase elevation > 1.5 X ULN
• 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