Trial · NCT02961374
Erlotinib Hydrochloride in Reducing Duodenal Polyp Burden in Patients With Familial Adenomatous Polyposis at Risk of Developing Colon Cancer
NCT02961374, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2021-09-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Erlotinib Hydrochloride in Reducing Duodenal Polyp Burden in Patients With Familial Adenomatous Polyposis at Risk of Developing Colon Cancer. Trials, record NCT02961374. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02961374
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Erlotinib Hydrochloride in Reducing Duodenal Polyp Burden in Patients With Familial Adenomatous Polyposis at Risk of Developing Colon Cancer
- NCT number
- NCT02961374
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 46 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Attenuated Familial Adenomatous Polyposis, Familial Adenomatous Polyposis
- Interventions
- Erlotinib, Erlotinib Hydrochloride
- First posted
- 2016-11-11
- Last updated
- 2022-07-26
- Results first posted
- 2021-09-22
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Percent Change in Duodenal Polyp Burden | Baseline to 6 months post-intervention | Assessed by esophagogastroduodenoscopy, the mean percent change was calculated by subtracting the sum of diameters from all polyps at baseline from the sum of diameters of all polyps at 6 months, then dividing by the sum of diameters from all polyps at baseline and multiplying by 100. |
| Primary | Number of Participants With Grade 2/3 Adverse Event (AE) | Up to 7 months from registration | Assessed according to National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The number of patients reporting a grade 2 or higher event are reported. |
| Secondary | Number of Participants With Any Adverse Events | Up to 7 months from registration | Assessed according to NCI CTCAE version 4.0. All registered and treated participants will be evaluable for AEs from the time of their first dose of weekly erlotinib treatment. To evaluate the AE profile for this treatment, the maximum grade for each type of adverse event will be recorded for each participant and frequency tables will be reviewed to determine the overall patterns. The number of patients reporting a grade 1 or higher adverse event at least possibly related to treatment are reported. |
| Secondary | Change in Duodenal Polyp Number | Baseline to 6 months | The number of duodenal polyps at baseline and the number of polyps remaining after 6 months of treatment will collected. The change in duodenal polyp number will be calculated for each patient by subtracting the baseline number of polyps from the 6 month number. Therefore a negative value indicates a decrease in the number of polyps present after 6 months. The median difference and standard deviation is reported. |
| Secondary | Absolute Change in Lower Gastrointestinal Polyp Burden | Baseline to 6 months | Lower GI polyp burden was defined using the Pouch Exam form as either 1) the average diameter reported for pouch for participants with ileal pouch-anal anastomosis (IPAA), or 2) the average diameter reported for rectum for participants with ileorectal anastomosis (IRA) + rectal stump. Absolute change from baseline to month 6 are reported here. |
| Secondary | Percent Change in Lower Gastrointestinal Polyp Burden | Baseline to 6 months | Lower GI polyp burden was defined using the Pouch Exam form as either 1) the average diameter reported for pouch for participants with ileal pouch-anal anastomosis (IPAA), or 2) the average diameter reported for rectum for participants with ileorectal anastomosis (IRA) + rectal stump. The percent change from baseline to month 6 are reported here. |
| Secondary | Absolute Change in Lower Gastrointestinal Polyp Number | Baseline to 6 months | Lower GI polyp number was defined using the Pouch Exam form as either 1) the number of polyps reported for pouch for participants with ileal pouch-anal anastomosis (IPAA), or 2) the number of polyps reported for rectum for participants with ileorectal anastomosis (IRA) + rectal stump. Absolute change from baseline to month 6 are reported here. |
| Secondary | Percent Change in Lower Gastrointestinal Polyp Number | Baseline to 6 months | Lower GI polyp number was defined using the Pouch Exam form as either 1) the number of polyps reported for pouch for participants with IPAA, or 2) the number of polyps reported for rectum for participants with IRA + rectal stump. |
| Secondary | Absolute and Percent Change in Desmoid Tumor Size | Baseline to 6 months | Laboratory measures will be correlated with participant outcomes (i.e., polyp burden, adverse events) and with each other as well. Cut-points will be determined based on previously defined and accepted standards. Descriptive statistics and simple scatter plots will be generated to review the tissue-based biomarker data. For continuous variables, the actual and % change in the level of each of the biomarkers from pre- to post-intervention will be explored using Wilcoxon signed rank tests, and paired sample t-tests. All categorical variables will be analyzed using chi-square tests or Fisher's exact test. For all translational endpoints, any notable statistical result will be viewed as an impetus for further study rather than as a definitive finding in and of itself. |
| Other | Immune Response Signaling in Duodenal Adenomas and Uninvolved Tissue | Up to 2.5 years | Laboratory measures will be correlated with participant outcomes (i.e., polyp burden, adverse events) and with each other as well. Cut-points will be determined based on previously defined and accepted standards. Descriptive statistics and simple scatter plots will be generated to review the tissue-based biomarker data. For continuous variables, the actual and % change in the level of each of the biomarkers from pre- to post-intervention will be explored using Wilcoxon signed rank tests, and paired sample t-tests. All categorical variables will be analyzed using chi-square tests or Fisher's exact test. For all translational endpoints, any notable statistical result will be viewed as an impetus for further study rather than as a definitive finding in and of itself. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Percent Change in Duodenal Polyp Burden | Baseline to 6 months post-intervention | Of the 46 patients registered, 42 patients began protocol treatment and were assessed at both baseline and at the 6 month timepoint. | percent change in Duodenal Polyp Burden | MEAN |
| PRIMARY | Number of Participants With Grade 2/3 Adverse Event (AE) | Up to 7 months from registration | All patients that registered and completed one course of treatment are included in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any Adverse Events | Up to 7 months from registration | All registered patients that began protocol treatment and were assessed for adverse events are included in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Duodenal Polyp Number | Baseline to 6 months | All patients that began protocol therapy and were assessed for duodenal polyp number at baseline and after 6 months are included in this analysis. | polyps | MEDIAN |
| SECONDARY | Absolute Change in Lower Gastrointestinal Polyp Burden | Baseline to 6 months | All registered participants who reported an average lower GI polyp diameter at both baseline and assessed at month 6 and were evaluable for change in lower GI polyp number. | polyps | MEDIAN |
| SECONDARY | Percent Change in Lower Gastrointestinal Polyp Burden | Baseline to 6 months | All registered participants who reported an average lower GI polyp diameter at both baseline and assessed at month 6 and were evaluable for change in lower GI polyp number. | Percent change in polyp burden | MEDIAN |
| SECONDARY | Absolute Change in Lower Gastrointestinal Polyp Number | Baseline to 6 months | All registered participants who reported total number of lower GI polyps at baseline and assessed at month 6 and were evaluable for change in lower GI polyp number. | Change in the polyp number | MEDIAN |
| SECONDARY | Percent Change in Lower Gastrointestinal Polyp Number | Baseline to 6 months | All registered participants who reported total number of lower GI polyps at baseline and assessed at month 6 and were evaluable for change in lower GI polyp number. | percent change in polyp number | MEDIAN |
| SECONDARY | Absolute and Percent Change in Desmoid Tumor Size | Baseline to 6 months | Data on desmoid tumor size was not collected. | ||
| OTHER_PRE_SPECIFIED | Immune Response Signaling in Duodenal Adenomas and Uninvolved Tissue | Up to 2.5 years |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Percent Change in Duodenal Polyp Burden | Treatment (Erlotinib Hydrochloride) | -29.6 | 95% Confidence Interval -39.6 to -19.7 | percent change in Duodenal Polyp Burden | |
| Number of Participants With Grade 2/3 Adverse Event (AE) | Treatment (Erlotinib Hydrochloride) | 33 | Participants | ||
| Number of Participants With Any Adverse Events | Treatment (Erlotinib Hydrochloride) | 41 | Participants | ||
| Change in Duodenal Polyp Number | Treatment (Erlotinib Hydrochloride) | -12.8 | Standard Deviation 22.96 | polyps | |
| Absolute Change in Lower Gastrointestinal Polyp Burden | Treatment (Erlotinib Hydrochloride) | 0 | Inter-Quartile Range 0 to 1 | polyps | |
| Percent Change in Lower Gastrointestinal Polyp Burden | Treatment (Erlotinib Hydrochloride) | 0 | Inter-Quartile Range 0 to 25.0 | Percent change in polyp burden | |
| Absolute Change in Lower Gastrointestinal Polyp Number | Treatment (Erlotinib Hydrochloride) | -6 | Inter-Quartile Range -26.0 to 0.0 | Change in the polyp number | |
| Percent Change in Lower Gastrointestinal Polyp Number | Treatment (Erlotinib Hydrochloride) | -30.8 | Inter-Quartile Range -47.4 to 0.0 | percent change in polyp number |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Erlotinib Hydrochloride) | 46 | |
| Overall Study | COMPLETED | Treatment (Erlotinib Hydrochloride) | 42 | |
| Overall Study | NOT COMPLETED | Treatment (Erlotinib Hydrochloride) | 4 |
Source ClinicalTrials.gov
Adverse events104
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Treatment (Erlotinib Hydrochloride) | 2 | 46 | 2 |
| other | Palpitations | Cardiac disorders | Treatment (Erlotinib Hydrochloride) | 2 | 46 | 3 |
| other | Ear pain | Ear and labyrinth disorders | Treatment (Erlotinib Hydrochloride) | 1 | 46 | 1 |
| other | Middle ear inflammation | Ear and labyrinth disorders | Treatment (Erlotinib Hydrochloride) | 1 | 46 | 1 |
| other | Tinnitus | Ear and labyrinth disorders | Treatment (Erlotinib Hydrochloride) | 1 | 46 | 1 |
| other | Cataract | Eye disorders | Treatment (Erlotinib Hydrochloride) | 1 | 46 | 1 |
| other | Dry eye | Eye disorders | Treatment (Erlotinib Hydrochloride) | 2 | 46 | 3 |
| other | Eye disorders - Other, specify | Eye disorders | Treatment (Erlotinib Hydrochloride) | 1 | 46 | 1 |
| other | Keratitis | Eye disorders | Treatment (Erlotinib Hydrochloride) | 1 | 46 | 1 |
| other | Photophobia | Eye disorders | Treatment (Erlotinib Hydrochloride) | 1 | 46 | 1 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Erlotinib Hydrochloride) | 0 | 46 |
| Total, other adverse events | Treatment (Erlotinib Hydrochloride) | 46 | 46 |
| Total, serious adverse events | Treatment (Erlotinib Hydrochloride) | 3 | 46 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02961374
GET https://conductscience.org/api/trials/v1/NCT02961374/events?page=2