Trial Outcomes & Findings for Phase II Trial of Erlotinib, Prior to Surgery or Radiation in Patients With Squamous Cell Cancers (SCC) of the Skin (NCT NCT01059305)

Last Updated: 2017-04-04

Results Overview

Response Evaluation Criteria In Solid Tumors (RECIST) criteria for CR = complete response, PR = partial response, SD = stable disease, PD = progressive disease, and NE = inevaluable. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): \>30% decrease in sum of diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): \>20% increase in sum of diameters of target lesions, reference smallest sum on study (this includes baseline sum if is smallest on study). In addition to relative increase of 20%, sum must absolute increase at least 5 mm. (Note: appearance of 1/\> new lesions also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum diameters while on study. Not evaluable (NE): Inevaluable when no imaging/measurement done

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

4 weeks

Results posted on

2017-04-04

Participant Flow

Recruitment Process: February 15, 2011 to September 11, 2012. All recruitment done at The University of Texas MD Anderson Cancer Center.

Participant milestones

Participant milestones
Measure	Erlotinib 150 mg daily orally before surgery and/or radiation therapy (Induction Treatment); and after surgery and/or radiation erlotinib for up to 1 year (Maintenance Phase).
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Trial of Erlotinib, Prior to Surgery or Radiation in Patients With Squamous Cell Cancers (SCC) of the Skin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erlotinib n=10 Participants 150 mg daily orally before surgery and/or radiation therapy (Induction Treatment); and after surgery and/or radiation erlotinib for up to 1 year (Maintenance Phase).
Age, Continuous	70 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

Outcome measures
Measure	Erlotinib n=10 Participants 150 mg daily orally before surgery and/or radiation therapy (Induction Treatment); and after surgery and/or radiation erlotinib for up to 1 year (Maintenance Phase).
Overall Response Complete Response	0 Participants
Overall Response Partial Response	1 Participants
Overall Response Stable Disease	7 Participants
Overall Response Progressive Disease	2 Participants

Adverse Events

Erlotinib

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Erlotinib n=10 participants at risk 150 mg daily orally before surgery and/or radiation therapy (Induction Treatment); and after surgery and/or radiation erlotinib for up to 1 year (Maintenance Phase).
Blood and lymphatic system disorders Anemia	10.0% 1/10 • Number of events 1 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Psychiatric disorders Anxiety	10.0% 1/10 • Number of events 1 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Cardiac disorders Atrial fibrillation	10.0% 1/10 • Number of events 1 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Musculoskeletal and connective tissue disorders Back pain	10.0% 1/10 • Number of events 1 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Eye disorders Blurred vision	10.0% 1/10 • Number of events 1 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Investigations Cholesterol high	30.0% 3/10 • Number of events 3 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Nervous system disorders Concentration impairment	10.0% 1/10 • Number of events 1 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Psychiatric disorders Confusion	10.0% 1/10 • Number of events 1 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Gastrointestinal disorders Constipation	10.0% 1/10 • Number of events 1 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Psychiatric disorders Depression	20.0% 2/10 • Number of events 2 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Gastrointestinal disorders Diarrhea	50.0% 5/10 • Number of events 8 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Nervous system disorders Dizziness	20.0% 2/10 • Number of events 2 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Eye disorders Dry eye	10.0% 1/10 • Number of events 1 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Gastrointestinal disorders Dry mouth	10.0% 1/10 • Number of events 1 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Skin and subcutaneous tissue disorders Dry skin	20.0% 2/10 • Number of events 2 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
General disorders Edema limbs	10.0% 1/10 • Number of events 1 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Eye disorders Eye pain	20.0% 2/10 • Number of events 2 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
General disorders Facial pain	10.0% 1/10 • Number of events 1 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
General disorders Fatigue	50.0% 5/10 • Number of events 5 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Musculoskeletal and connective tissue disorders Gait disturbance	10.0% 1/10 • Number of events 1 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Metabolism and nutrition disorders Glucose intolerance	10.0% 1/10 • Number of events 1 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Psychiatric disorders Hallucinations	10.0% 1/10 • Number of events 1 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Metabolism and nutrition disorders Hyperkalemia	20.0% 2/10 • Number of events 2 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Vascular disorders Hypertension	50.0% 5/10 • Number of events 5 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Metabolism and nutrition disorders Hypokalemia	10.0% 1/10 • Number of events 1 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Metabolism and nutrition disorders Hypomagnesemia	20.0% 2/10 • Number of events 2 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Metabolism and nutrition disorders Hyponatremia	10.0% 1/10 • Number of events 1 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Endocrine disorders Hypothyroidism	10.0% 1/10 • Number of events 1 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Infections and infestations Dental Infection	10.0% 1/10 • Number of events 1 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Investigations INR increased	10.0% 1/10 • Number of events 1 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Psychiatric disorders Insomnia	10.0% 1/10 • Number of events 1 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Nervous system disorders Memory impairment	10.0% 1/10 • Number of events 1 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Musculoskeletal and connective tissue disorders Myalgia	10.0% 1/10 • Number of events 1 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Gastrointestinal disorders Nausea	20.0% 2/10 • Number of events 2 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
General disorders Pain	10.0% 1/10 • Number of events 1 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Nervous system disorders Paresthesia	20.0% 2/10 • Number of events 2 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Infections and infestations Paronychia	10.0% 1/10 • Number of events 1 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Skin and subcutaneous tissue disorders Rash acneiform	70.0% 7/10 • Number of events 7 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Infections and infestations Skin infection	10.0% 1/10 • Number of events 2 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Nervous system disorders Stroke	10.0% 1/10 • Number of events 1 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Musculoskeletal and connective tissue disorders Trismus	10.0% 1/10 • Number of events 1 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Renal and urinary disorders Urinary incontinence	10.0% 1/10 • Number of events 1 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.
Eye disorders Watering eyes	10.0% 1/10 • Number of events 1 • Adverse events collected through maximum of 10 weeks of Erlotinib treatment.

Additional Information

Bonnie Glisson, MD/Professor, Thoracic/Head & Neck Med Oncology

The University of Texas (UT) MD Anderson Cancer Center

Phone: 713-792-7734

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place