Trial · NCT00754494

Erlotinib Hydrochloride in Treating Patients With Stage I-III Colorectal Cancer or Adenoma

NCT00754494, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2015-01-06

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Erlotinib Hydrochloride in Treating Patients With Stage I-III Colorectal Cancer or Adenoma. Trials, record NCT00754494. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00754494

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Erlotinib Hydrochloride in Treating Patients With Stage I-III Colorectal Cancer or Adenoma
NCT number: NCT00754494
Status: Completed
Phases: Phase 2
Enrollment: 45 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Adenomatous Polyp, Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage I Colon Cancer, Stage I Rectal Cancer, Stage IIA Colon Cancer, Stage IIA Rectal Cancer, Stage IIB Colon Cancer, Stage IIB Rectal Cancer, Stage IIC Colon Cancer, Stage IIC Rectal Cancer, Stage IIIA Colon Cancer, Stage IIIA Rectal Cancer, Stage IIIB Colon Cancer, Stage IIIB Rectal Cancer, Stage IIIC Colon Cancer, Stage IIIC Rectal Cancer
Interventions: erlotinib hydrochloride, placebo, laboratory biomarker analysis
First posted: 2008-09-18
Last updated: 2015-01-06
Results first posted: 2015-01-06

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in ACF pERK Levels	From baseline to post-treatment (up to 30 days)	Quantification will be performed by Western blot analysis. Tested using paired t-test with a two-sided significance level of 0.05.
Secondary	Change in EGF-inducible Markers - pEGFR in Normal Mucosa	From baseline to post-treatment (up to 30 days)	pEGFR expression levels were quantified by immunoblotting and calculated as the ratio of the pEGFR signals to reference signals. A log-transformation of pEGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.
Secondary	Change in EGF-inducible Markers - Total EGFR in Normal Mucosa	From baseline to post-treatment (up to 30 days)	Total EGFR expression levels were quantified by immunoblotting and calculated as the ratio of the total EGFR signals to reference signals. A log-transformation of total EGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.
Secondary	Change in EGF-inducible Markers - pEGFR in ACF	From baseline to post-treatment (up to 30 days)	pEGFR expression levels were quantified by immunoblotting and calculated as the ratio of the pEGFR signals to reference signals. A log-transformation of pEGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.
Secondary	Change in EGF-inducible Markers - Total EGFR in ACF	From baseline to post-treatment (up to 30 days)	Total EGFR expression levels were quantified by immunoblotting and calculated as the ratio of the total EGFR signals to reference signals. A log-transformation of total EGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.
Secondary	ACF: Normal Mucosa pERK Ratio	Up to day 30	Quantification will be performed by Western blot analysis. Tested using analysis of variance with subsequent pairwise comparisons using the Tukey method to adjust for multiple comparisons.
Secondary	Plasma Erlotinib Concentration (ng/mL)	Up to day 30	Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).
Secondary	Plasma OSI-420 Concentration (ng/mL)	Up to day 30	Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).
Secondary	Normal Mucosa Erlotinib Concentration (ng/mg)	Up to day 30	Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).
Secondary	Normal Mucosa OSI-420 Concentration (ng/mg)	Up to day 30	Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in ACF pERK Levels	From baseline to post-treatment (up to 30 days)	Change in ACF pERK levels not reported as the assay did not demonstrate signaling
SECONDARY	Change in EGF-inducible Markers - pEGFR in Normal Mucosa	From baseline to post-treatment (up to 30 days)	Outcome measure data is reported based on the evaluable samples collected and available results.	expression level	GEOMETRIC_MEAN
SECONDARY	Change in EGF-inducible Markers - Total EGFR in Normal Mucosa	From baseline to post-treatment (up to 30 days)	Outcome measure data is reported based on the evaluable samples collected and available results.	expression level	GEOMETRIC_MEAN
SECONDARY	Change in EGF-inducible Markers - pEGFR in ACF	From baseline to post-treatment (up to 30 days)	Outcome measure data is reported based on the evaluable samples collected and available results.	expression level	GEOMETRIC_MEAN
SECONDARY	Change in EGF-inducible Markers - Total EGFR in ACF	From baseline to post-treatment (up to 30 days)	Outcome measure data is reported based on the evaluable samples collected and available results.	expression level	GEOMETRIC_MEAN
SECONDARY	ACF: Normal Mucosa pERK Ratio	Up to day 30	ACF: pERK ratio not reported as the assay did not demonstrate signaling in ACF pERK levels
SECONDARY	Plasma Erlotinib Concentration (ng/mL)	Up to day 30	Outcome measure data is reported based on the evaluable samples collected and available results.	ng/mL	MEAN
SECONDARY	Plasma OSI-420 Concentration (ng/mL)	Up to day 30	Outcome measure data is reported based on the evaluable samples collected and available results.	ng/mL	MEAN
SECONDARY	Normal Mucosa Erlotinib Concentration (ng/mg)	Up to day 30	Outcome measure data is reported based on the evaluable samples collected and available results.	ng/mg	MEAN
SECONDARY	Normal Mucosa OSI-420 Concentration (ng/mg)	Up to day 30	Outcome measure data is reported based on the evaluable samples collected and available results.	ng/mg	MEAN

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group42

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in EGF-inducible Markers - pEGFR in Normal Mucosa	Arm I (25 mg)	0.84	95% Confidence Interval 0.27 to 2.58	expression level
Change in EGF-inducible Markers - pEGFR in Normal Mucosa	Arm II (50 mg)	1.65	95% Confidence Interval 0.87 to 3.10	expression level
Change in EGF-inducible Markers - pEGFR in Normal Mucosa	Arm III (100 mg)	0.97	95% Confidence Interval 0.68 to 1.38	expression level
Change in EGF-inducible Markers - Total EGFR in Normal Mucosa	Arm I (25 mg)	2.02	95% Confidence Interval 0.44 to 9.40	expression level
Change in EGF-inducible Markers - Total EGFR in Normal Mucosa	Arm II (50 mg)	1.91	95% Confidence Interval 0.91 to 4.00	expression level
Change in EGF-inducible Markers - Total EGFR in Normal Mucosa	Arm III (100 mg)	1.23	95% Confidence Interval 0.88 to 1.72	expression level
Change in EGF-inducible Markers - pEGFR in ACF	Arm I (25 mg)	1.19	95% Confidence Interval 0.57 to 2.48	expression level
Change in EGF-inducible Markers - pEGFR in ACF	Arm II (50 mg)	1.93	95% Confidence Interval 1.07 to 3.48	expression level
Change in EGF-inducible Markers - pEGFR in ACF	Arm III (100 mg)	1.40	95% Confidence Interval 0.78 to 2.53	expression level
Change in EGF-inducible Markers - Total EGFR in ACF	Arm I (25 mg)	1.33	95% Confidence Interval 0.38 to 4.61	expression level

1 to 10 of 42Source ClinicalTrials.gov

See all 42 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I (25 mg)	15
Overall Study	STARTED	Arm II (50 mg)	15
Overall Study	STARTED	Arm III (100 mg)	15
Overall Study	COMPLETED	Arm I (25 mg)	13
Overall Study	COMPLETED	Arm II (50 mg)	15
Overall Study	COMPLETED	Arm III (100 mg)	14
Overall Study	NOT COMPLETED	Arm I (25 mg)	2
Overall Study	NOT COMPLETED	Arm II (50 mg)	0
Overall Study	NOT COMPLETED	Arm III (100 mg)	1

Source ClinicalTrials.gov

Adverse events240

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	80% DIMINISHED SEBORRHEIC KERATOSIS SKIN LESIONS	Skin and subcutaneous tissue disorders	Arm I (25 mg)	1	15	1
other	80% DIMINISHED SEBORRHEIC KERATOSIS SKIN LESIONS	Skin and subcutaneous tissue disorders	Arm II (50 mg)	0	15	0
other	80% DIMINISHED SEBORRHEIC KERATOSIS SKIN LESIONS	Skin and subcutaneous tissue disorders	Arm III (100 mg)	0	15	0
other	ALLERGIC REACTION: RASH ON THE FACE	Skin and subcutaneous tissue disorders	Arm I (25 mg)	0	15	0
other	ALLERGIC REACTION: RASH ON THE FACE	Skin and subcutaneous tissue disorders	Arm II (50 mg)	0	15	0
other	ALLERGIC REACTION: RASH ON THE FACE	Skin and subcutaneous tissue disorders	Arm III (100 mg)	1	15	1
other	BLOODY NOSE	Respiratory, thoracic and mediastinal disorders	Arm I (25 mg)	0	15	0
other	BLOODY NOSE	Respiratory, thoracic and mediastinal disorders	Arm II (50 mg)	0	15	0
other	BLOODY NOSE	Respiratory, thoracic and mediastinal disorders	Arm III (100 mg)	1	15	1
other	BLUE COLORED URINE	Renal and urinary disorders	Arm I (25 mg)	0	15	0

1 to 10 of 240Source ClinicalTrials.gov

See all 240 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I (25 mg)
Total, all-cause mortality	Arm II (50 mg)
Total, all-cause mortality	Arm III (100 mg)
Total, other adverse events	Arm I (25 mg)	12	15
Total, other adverse events	Arm II (50 mg)	13	15
Total, other adverse events	Arm III (100 mg)	13	15
Total, serious adverse events	Arm I (25 mg)	1	15
Total, serious adverse events	Arm II (50 mg)	0	15
Total, serious adverse events	Arm III (100 mg)	0	15

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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
N01CN035160	PHASE I and II CLINICAL TRIALS OF CANCER CHEMOPREVENTIVE AGENTS-261035-261035160	MEYSKENS, FRANK L.	REGENTS OF THE UNIVERSITY OF	DIVISION OF CANCER PREVENTION AND CONTROL	2004 to 2006

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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