Phase 2 N=15 Treatment

A Trial of Erlotinib + Radiotherapy for Cutaneous Squamous Cell Carcinoma

Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00369512 ↗

Enrolled (actual)

Serious AEs

33.3%

Results posted

Aug 2013

Primary outcome: Primary: Toxicities Associated With Combined Radiotherapy and Erlotinib Treatments. — 15; 14; 12; 13 number of adverse events

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Erlotinib (Drug)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: University of Alabama at Birmingham
Primary completion: Jan 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Toxicities Associated With Combined Radiotherapy and Erlotinib Treatments.	15; 14; 12; 13; 11; 10	—
PRIMARY Median Time to Cancer Recurrence	10.5	—
PRIMARY Number of Patients With Recurrence at 2 Years	4	—

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.

Eligibility Criteria

Inclusion Criteria

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:
1. 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.
2. Histologically proven regional lymph node involvement (N1 disease). Fine needle aspiration or biopsy can be used to demonstrate the presence of lymphatic spread.
3. 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.
4. 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

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00369512). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.