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Phase II Study of Erlotinib, an Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor, in the Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Skin

Phase 2
18 Years
Open (Enrolling)
Skin Cancer

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Trial Information

Phase II Study of Erlotinib, an Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor, in the Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Skin

Erlotinib hydrochloride is designed to block the activity of a protein found on the surface
of many tumor cells that may control tumor growth and survival. This may stop tumors from

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive erlotinib 1
time each day. Erlotinib should be taken with a cup (8 ounces) of water at about the same
time each day.

Erlotinib should not be taken within 2 hours of taking short-acting antacid, such as Tums or

If you are having have side effects caused by erlotinib, your dose may be lowered or you may
be taken off study.

If you miss a dose and there is at least 12 hours before your next dose, you should take the
missed dose. lf you vomit, you should not take another tablet until your next scheduled

If necessary, erlotinib may be dissolved in water and given through a feeding tube.

You will be given a pill diary to record when you take erlotinib. You should bring your
pill diary to each visit to be reviewed by the study staff. You should also return any
unused tablets of erlotinib at each visit.

Study Visits:

On the day before you begin taking erlotinib and then every 4 weeks:

- You will be asked about any side effects you may be having or drugs you may be taking.

- You will have a physical exam, including measurement of your weight and vital signs.

- You will be asked about your smoking status.

- Your performance status will be recorded.

- Blood (about 2-3 teaspoons) will be drawn for routine tests, including tests to check
your blood clotting function.

Every 8 weeks:

- You will have a CT or MRI scan and a chest X-ray to check the status of the disease.

- If you have skin lesions, they will be measured and photographed.

Length of Study:

You may continue taking the study drug for as long as the doctor thinks it is in your best
interest. You will no longer be able to take the study drug if the disease gets worse or
intolerable side effects occur.

End-of-Treatment Visit:

About 30 days after your last dose of the study drug, the following tests and procedures
will be performed:

- You will be asked about any side effects you may be having and about any drugs you may
be taking.

- You will have a physical exam, including measurement of your vital signs.

- Your performance status will be recorded.

Long-Term Follow-Up:

After your end-of-treatment visit, you will be contacted by telephone, in writing, by
e-mail, or during clinic visits every 3 months to check the status of the disease and to ask
about any treatment you may have received and any other side effects you may have had. If
you cannot be found, your family members may be contacted for this information. This
information may also be collected by checking your medical record.

This is an investigational study. Erlotinib is FDA approved and commercially available for
the treatment of non-small cell lung cancer. Its use in this study is investigational.

Up to 33 patients will take part in this study. All will be enrolled at MD Anderson.

Inclusion Criteria:

1. Have histologically or cytologically confirmed cutaneous squamous cell carcinoma
(CSCC) that is not amenable to curative therapy. If the biopsy was collected outside
of MDACC, the MDACC Pathology Department must assess and confirm the SCC diagnosis.

2. Have measurable disease.

3. Be at least 18 years of age.

4. Have ECOG performance status 0-2.

5. Must have ability to understand and the willingness to sign a written Informed
Consent Document (ICD). In the event that non-English speaking participants are
eligible for this study, a short form (if applicable) or an ICD in their language
will be utilized and completed in accordance with the MDACC "Policy For Consenting
Non-English Speaking Participants."

6. Must have adequate organ and marrow function as follows:(a) leukocytes >/= 3,000/mm^3
(b) absolute neutrophil count >/= 1,500/mm^3 (c) platelets >/= 75,000/mm^3 (d)
hemoglobin >/= 8g/dL (e) total bilirubin (ULN) (f) AST(SGOT)/ALT(SGPT) alkaline phosphatase ULN or creatinine clearance >/= 60 mL/min/1.73 m^2

7. Prior radiotherapy is allowed if: (a) there is measurable disease outside the
radiation field OR (b) radiotherapy was completed more than 4 weeks ago and there is
clearly recurrent and growing disease within the radiation field.

8. Must be able to take intact tablets by mouth, or be able to take tablets dissolved in
water by mouth or by a percutaneous gastrostomy tube.

9. Patients - both males and females - with reproductive potential (includes women who
are menopausal for less than 1 year and not surgically sterilized) must practice
effective contraceptive measures such as barrier methods, condom or diaphragm with
spermicide, or abstinence throughout the study. Birth control should continue for 4
weeks after discontinuation of erlotinib therapy. Women of childbearing potential
must provide a negative pregnancy test (serum betaHCG) within 72 hours prior to first
receiving protocol therapy.

10. Organ transplant patients are eligible as long as they do not have active signs of
rejection and have adequate bone marrow function.

Exclusion Criteria:

1. Women who are pregnant, breastfeeding, and women and men not practicing effective
birth control. Erlotinib is a signal transduction inhibitor agent with the potential
for teratogenic or abortifacient effects. There is an unknown but potential risk for
adverse events in nursing infants secondary to treatment of the mother with
erlotinib. Breastfeeding should be discontinued if the mother is treated with

2. Prior EGFR inhibitor therapy is not allowed (including, but not limited to,
erlotinib, gefitinib, cetuximab, panitumumab, vandetanib).

3. Patients who are receiving any other anticancer or investigational agents at time of
study enrollment. Patients may have received one other systemic therapy or
investigational agent in the past, but a washout time period of at least 4 weeks and
recovery of any treatment-related toxicities to < CTCAEv4 grade 2 is required.

4. History of allergic reactions attributed to compounds of similar chemical or biologic
composition to erlotinib.

5. Patients with a history of an invasive malignancy (other than the one treated in this
study) or lymphoproliferative disorder within the past 3 years. Patients with a
history of adequately treated non-melanoma skin cancer, ductal carcinoma in situ of
the breast, or carcinoma in situ of the cervix are allowed.

6. Patients with incomplete healing from previous surgery.

7. Patients with pulmonary fibrosis (other than in a radiated field) or active
interstitial lung disease.

8. Patients with active gastrointestinal disease or a disorder that alters
gastrointestinal motility or absorption, including lack of integrity of the
gastrointestinal tract (for example, a significant surgical resection of the stomach
or small bowel, inflammatory bowel disease or uncontrolled chronic diarrhea.

9. Patients with skin rash ≥ CTCAEv4 grade 2

10. In the opinion of the investigator, patients with any condition that is unstable or
could jeopardize the safety of the patient or could limit compliance with the study's
requirements. These include, but are not limited to, ongoing or active infection
requiring parenteral antibiotics at time of study registration, psychiatric illness
that would limit compliance with study requirements or symptomatic congestive heart
failure (NYHA class II or greater), unstable angina pectoris or cardiac arrhythmia
requiring maintenance medication.

11. Patient is unwilling or unable to discontinue prohibited concomitant therapies, (i.e
St. John's wort, grapefruit juice, H2 blockers/proton pump inhibitors, strong CYP3A4
inhibitors and inducers).

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate (ORR)

Outcome Description:

Evaluated after 8 weeks, patient considered a non-responder if tumor does not regress to complete or partial response as specified in RECIST v1.1 at that time point. ORR, based on overall response of each evaluable patient, is defined as percentage of patients who achieve an overall response of complete response or partial response in total number of evaluable patients.

Outcome Time Frame:

8 weeks

Safety Issue:


Principal Investigator

Kathryn A. Gold, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

March 2011

Completion Date:

Related Keywords:

  • Skin Cancer
  • Squamous cell carcinoma of the skin
  • Cutaneous squamous cell carcinoma
  • CSCC
  • epidermal growth factor receptor
  • EGFR
  • tyrosine kinase inhibitor
  • recurrent
  • Erlotinib
  • Erlotinib hydrochloride
  • OSI-774
  • Tarceva
  • Carcinoma
  • Skin Neoplasms
  • Carcinoma, Squamous Cell



UT MD Anderson Cancer CenterHouston, Texas  77030