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A Phase III Trial of Erlotinib and Radiotherapy in Patients With Stage III Cutaneous Squamous Cell Carcinomas


Phase 2
20 Years
N/A
Open (Enrolling)
Both
Cancer

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Trial Information

A Phase III Trial of Erlotinib and Radiotherapy in Patients With Stage III Cutaneous Squamous Cell Carcinomas


This is a single-institution, open-label, non-randomized phase II trial of erlotinib
administered concomitantly with radiation therapy following surgical resection of gross
disease. A total of 45 patients with previously unirradiated, high-risk cutaneous SCC
requiring post-operative radiotherapy will be enrolled to assess the primary endpoints of
time to recurrence and disease free survival. Pretreatment biopsies will be required to
confirm the histological diagnosis of SCC. Four to six weeks after surgical resection,
patients will begin erlotinib (150 mg po qd) beginning the first day of radiotherapy.
Patients will receive 5040 cGy beginning on day 1 of therapy in standard fractionations.
Patients will be followed to evaluate for toxicity based on NCI common toxicity criteria
(v3.0). Patients will be followed on protocol for a minimum of 2 years with regularly
scheduled CT scans, clinical evaluations, and laboratory work. Patients with residual or
recurrent cancer will be taken off protocol for salvage therapy.

As a secondary objective, molecular response of tumors to erlotinib monotherapy will be
determined. When possible, participants will be enrolled and treated for 14 days with
erlotinib prior to surgical resection. The pretreatment biopsy specimen (control) will then
be compared to tissue acquired during the surgical resection after 14 days of erlotinib
(experimental group).


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess toxicities associated with combined radiotherapy and erlotinib treatments.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Eben Rosenthal, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Institutional Review Board

Study ID:

F060106002

NCT ID:

NCT00369512

Start Date:

August 2006

Completion Date:

April 2012

Related Keywords:

  • Cancer
  • Phase II
  • Erlotinib
  • Radiotherapy
  • Squamous Cell Carcinomas
  • Cutaneous
  • Stage III
  • Carcinoma
  • Carcinoma, Squamous Cell

Name

Location

University of Alabama at Birmingham Medical CenterBirmingham, Alabama  35233