Trial Outcomes & Findings for Erlotinib in Treating Patients With Recurrent or Metastatic Skin Squamous Cell Carcinoma (NCT NCT01198028)

NCT ID: NCT01198028

Last Updated: 2020-06-11

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 42 participants
• Primary outcome timeframe: up to 6 years
• Results posted on: 2020-06-11

Participant Flow

Participants were recruited in head and neck clinic and from referrals from outside clinics between April 2011 and June 2014 at MD Anderson Cancer Center.

A total of 42 participants enrolled,39 participants started 1 withdrew, 1 came off study the same day consented and 1 participant was ineligible.

Participant milestones

Measure	Erlotinib 150 mg once daily by mouth.
Overall Study STARTED	39
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Measure	Erlotinib 150 mg once daily by mouth.
Overall Study Adverse Event	5
Overall Study Death	3
Overall Study Physician Decision	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Erlotinib n=39 Participants 150 mg once daily by mouth.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Erlotinib n=29 Participants 150 mg once daily by mouth.
Overall Response Rate	3 Participants

SECONDARY outcome

Timeframe: up to 6 years

The time from initial response during therapy to progression of disease evaluated using Kaplan-Meier estimation techniques.

Outcome measures

Measure	Erlotinib n=29 Participants 150 mg once daily by mouth.
Duration of Response	5.3 months Interval 4.6 to 13.2

SECONDARY outcome

Timeframe: up to 6 years

The date of stable disease to the date of loss of stable disease or last follow-up.

Outcome measures

Measure	Erlotinib n=39 Participants 150 mg once daily by mouth.
Duration of Stable Disease	7.2 months Interval 1.6 to 41.4

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Erlotinib n=39 Participants 150 mg once daily by mouth.
Progression-free Survival	4.7 months Interval 3.5 to 6.2

SECONDARY outcome

Timeframe: up to 6 years

Time from date of treatment start until date of death due to any cause or last Follow-up.

Outcome measures

Measure	Erlotinib n=39 Participants 150 mg once daily by mouth.
Overall Survival	13 months Interval 8.4 to 20.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Erlotinib n=39 Participants 150 mg once daily by mouth.
Number of Participants With Safety and Tolerability of Erlotinib Dry eyes	4 Participants
Number of Participants With Safety and Tolerability of Erlotinib Watery eyes	10 Participants
Number of Participants With Safety and Tolerability of Erlotinib Constipation	5 Participants
Number of Participants With Safety and Tolerability of Erlotinib Nausea/Vomitting	10 Participants
Number of Participants With Safety and Tolerability of Erlotinib Oral Mucositis	8 Participants
Number of Participants With Safety and Tolerability of Erlotinib Fatigue	14 Participants
Number of Participants With Safety and Tolerability of Erlotinib Acneiform rash	22 Participants

Adverse Events

Erlotinib

Serious events: 7 serious events

Other events: 22 other events

Deaths: 7 deaths

Serious adverse events

Measure	Erlotinib n=39 participants at risk 150 mg once daily by mouth.
Investigations Alanine aminotransferase increased	2.6% 1/39 • up to 6 years
Infections and infestations Lung Infection	2.6% 1/39 • up to 6 years
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	2.6% 1/39 • up to 6 years
Blood and lymphatic system disorders Anemia (grade 3)	2.6% 1/39 • up to 6 years
Gastrointestinal disorders Nausea (grade 3)	2.6% 1/39 • up to 6 years
Gastrointestinal disorders Diarrhea (grade 3)	2.6% 1/39 • up to 6 years
Gastrointestinal disorders Vomitting	2.6% 1/39 • up to 6 years

Other adverse events

Measure	Erlotinib n=39 participants at risk 150 mg once daily by mouth.
Skin and subcutaneous tissue disorders Acneiform rash	56.4% 22/39 • up to 6 years
General disorders Fatigue	35.9% 14/39 • up to 6 years
Eye disorders Dry eyes	10.3% 4/39 • up to 6 years
Gastrointestinal disorders Oral Mucositis	20.5% 8/39 • up to 6 years
Gastrointestinal disorders Nausea/Vomiting	25.6% 10/39 • up to 6 years
Gastrointestinal disorders Constipation	12.8% 5/39 • up to 6 years
Eye disorders Watery eyes	25.6% 10/39 • up to 6 years

Additional Information

Dr. Bonnie Glisson, MD,Professor, Thoracic-Head & Neck Med Onc

MD Anderson Cancer Center

Phone: (713) 792-6363

Email: bglisson@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place