Status:
COMPLETED
A Clinical Trial of COX and EGFR Inhibition in Familial Polyposis Patients
Lead Sponsor:
University of Utah
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Adenomatous Polyposis Coli
Eligibility:
All Genders
18-69 years
Phase:
PHASE2
Brief 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 ad...
Detailed Description
This will be a single-center, phase-II, six-month-long, placebo-controlled, double blinded, randomized trial of the epidermal growth factor receptor (EGFR) inhibitor, erlotinib (Tarceva) and the cyclo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT01187901
Start Date
April 1 2010
End Date
July 1 2014
Last Update
June 17 2016
Active Locations (1)
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1
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112