Phase 2
N=46
Erlotinib Hydrochloride in Reducing Duodenal Polyp Burden in Patients With Familial Adenomatous Polyposis at Risk of Developing Colon Cancer
Attenuated Familial Adenomatous Polyposis · Familial Adenomatous Polyposis
Bottom Line
View on ClinicalTrials.gov: NCT02961374 ↗Enrolled (actual)
46
Serious AEs
6.5%
Results posted
Sep 2021
Primary outcome: Primary: Mean Percent Change in Duodenal Polyp Burden — -29.6 percent change in Duodenal Polyp Burden
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Erlotinib (Drug); Erlotinib Hydrochloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Change in Duodenal Polyp Burden |
-29.6 | — |
| PRIMARY Number of Participants With Grade 2/3 Adverse Event (AE) |
33 | — |
| SECONDARY Number of Participants With Any Adverse Events |
41 | — |
| SECONDARY Change in Duodenal Polyp Number |
-12.8 | — |
| SECONDARY Absolute Change in Lower Gastrointestinal Polyp Burden |
— | — |
| SECONDARY Percent Change in Lower Gastrointestinal Polyp Burden |
— | — |
| SECONDARY Absolute Change in Lower Gastrointestinal Polyp Number |
-6 | — |
| SECONDARY Percent Change in Lower Gastrointestinal Polyp Number |
-30.8 | — |
| SECONDARY Absolute and Percent Change in Desmoid Tumor Size |
— | — |
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.
Eligibility Criteria
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 = = 3,000/uL (>= 2,500/uL for African-American participants)
- Platelet count >= 100 x 10^9/L
- Hemoglobin >= 11.5 g/dL
- Total bilirubin = = 2 times per week) use of drugs that alter the pH of the gastrointestinal tract (GI) tract, such as proton pump inhibitors (PPI) and antacids; exceptions: individuals who use prescription PPIs and have approval from their primary health care provider to replace the PPI with an H2 receptor agonist, i.e. ranitidine, for the duration of the trial will be eligible
- Gastrointestinal bleeding; note that the presence of any symptoms (dyspnea, fatigue, angina, weakness, malaise, melena, hematochezia, hematemesis, anemia, abdominal pain) will require clinical assessment to rule out gastrointestinal bleeding
Data sourced from ClinicalTrials.gov (NCT02961374). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.