Trial · NCT01198028

Erlotinib in Treating Patients With Recurrent or Metastatic Skin Squamous Cell Carcinoma

NCT01198028, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2020-06-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Erlotinib in Treating Patients With Recurrent or Metastatic Skin Squamous Cell Carcinoma. Trials, record NCT01198028. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01198028

On this page

Trial

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

Title: Erlotinib in Treating Patients With Recurrent or Metastatic Skin Squamous Cell Carcinoma
NCT number: NCT01198028
Status: Completed
Phases: Phase 2
Enrollment: 42 participants, actual
Lead sponsor: M.D. Anderson Cancer Center
Conditions: Metastatic Skin Squamous Cell Carcinoma, Recurrent Skin Squamous Cell Carcinoma
Interventions: Erlotinib
First posted: 2010-09-09
Last updated: 2020-06-11
Results first posted: 2020-06-11

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Overall Response Rate	up to 6 years	Overall response rate defined as the percentage of patients who achieve an overall response of complete response or partial response in the total number of evaluable patients, assessed by Response Evaluation Criteria in Solid Tumors 1.1A Bayesian design based on predictive probability will be implemented.
Secondary	Duration of Response	up to 6 years	The time from initial response during therapy to progression of disease evaluated using Kaplan-Meier estimation techniques.
Secondary	Duration of Stable Disease	up to 6 years	The date of stable disease to the date of loss of stable disease or last follow-up.
Secondary	Progression-free Survival	up to 6 years	Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Secondary	Overall Survival	up to 6 years	Time from date of treatment start until date of death due to any cause or last Follow-up.
Secondary	Number of Participants With Safety and Tolerability of Erlotinib	Baseline start of treatment, up to 30 days after treatment or to death, up to 6 years	Frequency of adverse events according to the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0. Standard reporting guidelines followed for adverse events.

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Overall Response Rate	up to 6 years	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Duration of Response	up to 6 years	months	MEDIAN
SECONDARY	Duration of Stable Disease	up to 6 years	months	MEDIAN
SECONDARY	Progression-free Survival	up to 6 years	months	MEDIAN
SECONDARY	Overall Survival	up to 6 years	months	MEDIAN
SECONDARY	Number of Participants With Safety and Tolerability of Erlotinib	Baseline start of treatment, up to 30 days after treatment or to death, up to 6 years	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Category	Value	Spread	Units
Overall Response Rate	Erlotinib		3		Participants
Duration of Response	Erlotinib		5.3	Full Range 4.6 to 13.2	months
Duration of Stable Disease	Erlotinib		7.2	95% Confidence Interval 1.6 to 41.4	months
Progression-free Survival	Erlotinib		4.7	95% Confidence Interval 3.5 to 6.2	months
Overall Survival	Erlotinib		13	95% Confidence Interval 8.4 to 20.5	months
Number of Participants With Safety and Tolerability of Erlotinib	Erlotinib	Dry eyes	4		Participants
Number of Participants With Safety and Tolerability of Erlotinib	Erlotinib	Watery eyes	10		Participants
Number of Participants With Safety and Tolerability of Erlotinib	Erlotinib	Constipation	5		Participants
Number of Participants With Safety and Tolerability of Erlotinib	Erlotinib	Nausea/Vomitting	10		Participants
Number of Participants With Safety and Tolerability of Erlotinib	Erlotinib	Oral Mucositis	8		Participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Erlotinib	39
Overall Study	COMPLETED	Erlotinib	29
Overall Study	NOT COMPLETED	Erlotinib	10

Source ClinicalTrials.gov

Adverse events14

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
other	Acneiform rash	Skin and subcutaneous tissue disorders	Erlotinib	22	39
other	Fatigue	General disorders	Erlotinib	14	39
other	Dry eyes	Eye disorders	Erlotinib	4	39
other	Oral Mucositis	Gastrointestinal disorders	Erlotinib	8	39
other	Nausea/Vomiting	Gastrointestinal disorders	Erlotinib	10	39
other	Constipation	Gastrointestinal disorders	Erlotinib	5	39
other	Watery eyes	Eye disorders	Erlotinib	10	39
serious	Alanine aminotransferase increased	Investigations	Erlotinib	1	39
serious	Lung Infection	Infections and infestations	Erlotinib	1	39
serious	Bronchopulmonary hemorrhage	Respiratory, thoracic and mediastinal disorders	Erlotinib	1	39

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Erlotinib	7	39
Total, other adverse events	Erlotinib	22	39
Total, serious adverse events	Erlotinib	7	39

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29579331	DERIVED

Source PubMed

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
P30CA016672	The University of Texas MD Anderson Cancer Center Support Grant (CCSG)	KOONG, ALBERT	UNIVERSITY OF TX MD ANDERSON CAN CTR	NATIONAL CANCER INSTITUTE	1985 to 2026

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.

GET https://conductscience.org/api/trials/v1/NCT01198028

GET https://conductscience.org/api/trials/v1/NCT01198028/registered

API reference For AI assistants