Erlotinib Hydrochloride in Reducing Duodenal Polyp Burden in Patients With Familial Adenomatous P… (NCT02961374) | Clinical Trial Compass
CompletedPhase 2
Erlotinib Hydrochloride in Reducing Duodenal Polyp Burden in Patients With Familial Adenomatous Polyposis at Risk of Developing Colon Cancer
United States46 participantsStarted 2017-10-27
Plain-language summary
This phase II trial studies the side effects of erlotinib hydrochloride and how well it works in reducing duodenal polyp burden in patients with familial adenomatous polyposis at risk of developing colon cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range18 Years – 69 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* PRE-REGISTRATION INCLUSION
* Diagnosis of familial adenomatous polyposis (FAP) or attenuated familial adenomatous polyposis (AFAP), defined as at least one of the following:
* Genetic diagnosis with confirmed APC mutation (Clinical Laboratory Improvement Act \[CLIA\] certified lab or research testing)
* Obligate carrier
* Clinical diagnosis of classic FAP with \>= 100 colorectal adenomas status post colectomy and a family history of FAP
* Clinical diagnosis of FAP, based on personal and family history; Note: This criterion requires documented review and agreement from either the study chair or the Cancer Prevention Network (CPN) lead investigator
* Ability to understand and the willingness to sign a written informed consent document
* Willing to discontinue taking nonsteroidal anti-inflammatory drugs (NSAIDS) for 30 days prior to initiation of and during intervention; exception: use of =\< 81 mg daily or =\< 650 mg weekly aspirin is allowed
* Willing to discontinue smoking for the duration of study intervention
* Willing to provide mandatory biospecimens as specified in the protocol
* REGISTRATION INCLUSION
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
* Leukocytes (white blood cells \[WBC\]) \>= 3,000/uL (\>= 2,500/uL for African-American participants)
* Platelet count \>= 100 x 10\^9/L
* Hemoglobin \>= 11.5 g/dL
* Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN)
* Alkaline phosphatase =\< 1.5 x instit…
What they're measuring
1
Mean Percent Change in Duodenal Polyp Burden
Timeframe: Baseline to 6 months post-intervention
2
Number of Participants With Grade 2/3 Adverse Event (AE)