A Clinical Trial of COX and EGFR Inhibition in Familial Polyposis Patients

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine in a randomized, placebo-controlled, phase II trial if the combination of sulindac and erlotinib causes a significant regression of duodenal and colorectal adenomas in familial adenomatous polyposis (FAP) and attenuated FAP (AFAP) patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Collaborator: National Cancer Institute (NCI)
• Treatments: Erlotinib Hydrochloride; Sulindac

Criteria

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:

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