A Trial of Erlotinib + Radiotherapy for Cutaneous Squamous Cell Carcinoma

NCT00369512 | Completed Phase 2 Results DMC

• 1 other identifier: F060106002
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II study designed to study the effectiveness of combined radiotherapy and erlotinib in the postoperative setting for patients with cutaneous SCC that are at high risk for recurrence. Participants enrolled in the study will be evaluated by a head and neck surgeon, and a radiation oncologist. Whenever possible, a preoperative biopsy will be performed after participant enrollment in the study for histological confirmation and for molecular correlates. Participants enrolled prior to surgical resection will begin erlotinib at 150 mg by mouth (PO) every day (QD) (14 tablets) to be taken 14 days prior to surgical resection. Following planned surgical resection, the participant will begin Erlotinib therapy and radiotherapy at the same time and within 4-8 weeks of the surgical resection.

Conditions

Cancer

Keywords

Phase II; Erlotinib; Radiotherapy; Squamous Cell Carcinomas; Cutaneous; Stage III

Outcome Measures

Primary Outcomes (3)

• Toxicities Associated With Combined Radiotherapy and Erlotinib Treatments.

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

  2 years

• Median Time to Cancer Recurrence

  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.

  2 years

• Number of Patients With Recurrence at 2 Years

  Rate of recurrence at 2 years.

  2 years

Study Arms (1)

Erlotinib

EXPERIMENTAL

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).

Drug: Erlotinib

Interventions

Erlotinib DRUG

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).

Also known as: Tarceva

Erlotinib

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven primary or recurrent squamous cell carcinoma arising from the lip or skin of the face, ear, scalp or neck.
• Participants must meet one of the four criteria:
• \. T4 cutaneous SCC as determined by physical exam, imaging studies, prior resections or biopsy. T4 disease is defined as tumor that invades deep extradermal structures such as cartilage, skeletal muscle (e.g., muscles of facial expression), parotid gland or bone.Patients with a T2 or greater squamous cell carcinoma of the lower lip who will require post operative radiation will be allowed.
• \. Histologically proven regional lymph node involvement (N1 disease). Fine needle aspiration or biopsy can be used to demonstrate the presence of lymphatic spread.
• \. Histologically proven parotid gland metastasis. Fine needle aspiration or biopsy can be used to demonstrate the presence of regional spread. Includes delayed regional metastasis; primary scalp or other skin lesion treated within 36 months that would drain into the involved parotid.
• \. Patients who following surgical resection of the primary are found to have histologically positive lymph nodes (N1). Includes delayed regional metastasis; primary lip or cutaneous lesion treated within 36 months that would drain into the involved nodal basin.
• Age \> 19 years
• Tumors must be considered surgically resectable.(Patients may be enrolled after surgery is completed as long as Erlotinib therapy and concurrent radiation is started within 8 weeks of surgical resection.)
• Required laboratory data obtained prior to beginning treatment: WBC \> 1,500/ml; Platelets \> 90,000; serum creatinine ≤ 2.0 mg/dl
• The patient may have had a prior non-cutaneous malignancy, but must be two years from treatment.
• Performance status of ≤ 2 (ECOG scale) and life expectancy ≥ 12 months.
• The patients must agree to use effective contraception if there is the potential for procreativity. Contraception must be conducted for at least 3 months following the study.
• Patients must sign informed consent

You may not qualify if:

• The patient has received prior radiation therapy to the head and neck.
• The patient is pregnant or lactating
• Patients with a prior history of head and neck mucosal cancers.
• Psychological condition that renders the patient unable to understand the informed consent.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Genentech, Inc.: collaborator
• OSI Pharmaceuticals: collaborator

Study Sites (1)

University of Alabama at Birmingham Medical Center

Birmingham, Alabama, 35233, United States

Location

Related Publications (1)

• Heath CH, Deep NL, Nabell L, Carroll WR, Desmond R, Clemons L, Spencer S, Magnuson JS, Rosenthal EL. Phase 1 study of erlotinib plus radiation therapy in patients with advanced cutaneous squamous cell carcinoma. Int J Radiat Oncol Biol Phys. 2013 Apr 1;85(5):1275-81. doi: 10.1016/j.ijrobp.2012.09.030. Epub 2012 Nov 22.

  PMID: 23182701 RESULT

MeSH Terms

Conditions

Neoplasms; Carcinoma, Squamous Cell

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Eben Rosenthal, MD Department of Surgery Department
• Organization: University of Alabama at Birmingham

erosenthal@uabmc.edu

(205) 934-9714

Study Officials

• Eben Rosenthal, M.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery - Otolaryngology

Study Record Dates

• First Submitted: August 24, 2006
• First Posted: August 29, 2006
• Study Start: August 1, 2006
• Primary Completion: January 1, 2012
• Study Completion: September 1, 2012
• Last Updated: May 30, 2017
• Results First Posted: August 8, 2013

Record last verified: 2017-05

Locations

US (1)