Trial Outcomes & Findings for A Trial of Erlotinib + Radiotherapy for Cutaneous Squamous Cell Carcinoma (NCT NCT00369512)

NCT ID: NCT00369512

Last Updated: 2017-05-30

Results Overview

Number of gradeable toxicities (via CTCAE manual) experienced by patients on this protocol--number of events

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 15 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2017-05-30

Participant Flow

Period of recruitment was December 2006 to June 2009. Patients were screened from radiation and head/neck clinics at UAB Hospital.

Single Arm study

Participant milestones

Measure	Erlotinib Erlotinib therapy for 2 weeks (150 mg by mouth (PO) every day(QD))(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Trial of Erlotinib + Radiotherapy for Cutaneous Squamous Cell Carcinoma

Baseline characteristics by cohort

Measure	Erlotinib n=15 Participants Erlotinib therapy for 2 weeks (150 mg once per day)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg once per day).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Age, Continuous	68 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Number of gradeable toxicities (via CTCAE manual) experienced by patients on this protocol--number of events

Outcome measures

Measure	Erlotinib n=15 Participants Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
Toxicities Associated With Combined Radiotherapy and Erlotinib Treatments. Dermatitis	15 number of adverse events
Toxicities Associated With Combined Radiotherapy and Erlotinib Treatments. Radiation Dermatitis	14 number of adverse events
Toxicities Associated With Combined Radiotherapy and Erlotinib Treatments. Tarceva Dermatitis	12 number of adverse events
Toxicities Associated With Combined Radiotherapy and Erlotinib Treatments. Mucositis	13 number of adverse events
Toxicities Associated With Combined Radiotherapy and Erlotinib Treatments. Esophagitis	11 number of adverse events
Toxicities Associated With Combined Radiotherapy and Erlotinib Treatments. Nausea/Vomitting	10 number of adverse events

PRIMARY outcome

Timeframe: 2 years

Per protocol, patients were followed every 3 months for recurrent disease by physical exam and imaging (MRI/CT). Recurrence, in most cases, is detected during routine history/physical exam. If disease was detected during follow-up, every attempt was made to obtain pathological confirmation of recurrence.

Outcome measures

Measure	Erlotinib n=15 Participants Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
Median Time to Cancer Recurrence	10.5 months Interval 1.0 to 14.0

PRIMARY outcome

Timeframe: 2 years

Rate of recurrence at 2 years.

Outcome measures

Measure	Erlotinib n=15 Participants Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
Number of Patients With Recurrence at 2 Years	4 participants

Adverse Events

Erlotinib

Serious events: 5 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	Erlotinib n=15 participants at risk Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
Metabolism and nutrition disorders Dehydration	20.0% 3/15 • Adverse Events were reported during treatment and continued to 2 year follow-up.
Nervous system disorders Syncope	6.7% 1/15 • Adverse Events were reported during treatment and continued to 2 year follow-up.
Psychiatric disorders Confusion	6.7% 1/15 • Adverse Events were reported during treatment and continued to 2 year follow-up.
Cardiac disorders Myocardial Infarction	6.7% 1/15 • Adverse Events were reported during treatment and continued to 2 year follow-up.
Gastrointestinal disorders Vomiting	6.7% 1/15 • Adverse Events were reported during treatment and continued to 2 year follow-up.
Gastrointestinal disorders Nausea	13.3% 2/15 • Adverse Events were reported during treatment and continued to 2 year follow-up.
Cardiac disorders CardioPulmonary Arrest	6.7% 1/15 • Adverse Events were reported during treatment and continued to 2 year follow-up.
Vascular disorders Hematomia-Periorbital	6.7% 1/15 • Adverse Events were reported during treatment and continued to 2 year follow-up.
Vascular disorders Venous Occulsion	6.7% 1/15 • Adverse Events were reported during treatment and continued to 2 year follow-up.
Musculoskeletal and connective tissue disorders Cellulitis-Thigh	6.7% 1/15 • Adverse Events were reported during treatment and continued to 2 year follow-up.
Gastrointestinal disorders Dysphagia	6.7% 1/15 • Adverse Events were reported during treatment and continued to 2 year follow-up.
Metabolism and nutrition disorders Weight Loss	6.7% 1/15 • Adverse Events were reported during treatment and continued to 2 year follow-up.
Metabolism and nutrition disorders Anoxeria	6.7% 1/15 • Adverse Events were reported during treatment and continued to 2 year follow-up.
Infections and infestations Oral Thrush	6.7% 1/15 • Adverse Events were reported during treatment and continued to 2 year follow-up.
Infections and infestations Orbital Cavity Infection	6.7% 1/15 • Adverse Events were reported during treatment and continued to 2 year follow-up.

Other adverse events

Measure	Erlotinib n=15 participants at risk Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
Skin and subcutaneous tissue disorders Dermatitis	60.0% 9/15 • Number of events 15 • Adverse Events were reported during treatment and continued to 2 year follow-up.
Gastrointestinal disorders Oral Pain	13.3% 2/15 • Number of events 2 • Adverse Events were reported during treatment and continued to 2 year follow-up.
Skin and subcutaneous tissue disorders Acneiform Rash	6.7% 1/15 • Number of events 1 • Adverse Events were reported during treatment and continued to 2 year follow-up.
Skin and subcutaneous tissue disorders Erythema of Flap/Lip Commissure	13.3% 2/15 • Number of events 2 • Adverse Events were reported during treatment and continued to 2 year follow-up.
Skin and subcutaneous tissue disorders Radiation Dermatitis	26.7% 4/15 • Number of events 4 • Adverse Events were reported during treatment and continued to 2 year follow-up.
Eye disorders Ocular/Visual	13.3% 2/15 • Number of events 2 • Adverse Events were reported during treatment and continued to 2 year follow-up.
Skin and subcutaneous tissue disorders Fractured Teeth	6.7% 1/15 • Number of events 1 • Adverse Events were reported during treatment and continued to 2 year follow-up.
Gastrointestinal disorders Vomiting	6.7% 1/15 • Number of events 1 • Adverse Events were reported during treatment and continued to 2 year follow-up.
Nervous system disorders Syncope	6.7% 1/15 • Number of events 1 • Adverse Events were reported during treatment and continued to 2 year follow-up.
Gastrointestinal disorders Radiation Mucositis	20.0% 3/15 • Number of events 3 • Adverse Events were reported during treatment and continued to 2 year follow-up.
Nervous system disorders Headache	6.7% 1/15 • Number of events 1 • Adverse Events were reported during treatment and continued to 2 year follow-up.
Musculoskeletal and connective tissue disorders Soft Tissue Necrosis	6.7% 1/15 • Number of events 1 • Adverse Events were reported during treatment and continued to 2 year follow-up.
General disorders Leg and Back Pain	13.3% 2/15 • Number of events 2 • Adverse Events were reported during treatment and continued to 2 year follow-up.
Respiratory, thoracic and mediastinal disorders Left Chest Nodule	6.7% 1/15 • Number of events 1 • Adverse Events were reported during treatment and continued to 2 year follow-up.
General disorders Face Pain	6.7% 1/15 • Number of events 1 • Adverse Events were reported during treatment and continued to 2 year follow-up.
Gastrointestinal disorders Dysphagia	6.7% 1/15 • Number of events 1 • Adverse Events were reported during treatment and continued to 2 year follow-up.
Cardiac disorders Bradycardia	6.7% 1/15 • Number of events 1 • Adverse Events were reported during treatment and continued to 2 year follow-up.
Nervous system disorders Neuropathy CN	6.7% 1/15 • Number of events 1 • Adverse Events were reported during treatment and continued to 2 year follow-up.

Additional Information

Eben Rosenthal, MD Department of Surgery Department

University of Alabama at Birmingham

Phone: (205) 934-9714

Email: erosenthal@uabmc.edu

Results disclosure agreements

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