Study of Erlotinib in the Treatment of Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (CSCC) of the Skin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01198028
Recruitment Status : Active, not recruiting
First Posted : September 9, 2010
Last Update Posted : September 27, 2017
OSI Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

September 8, 2010
September 9, 2010
September 27, 2017
March 2011
March 2019   (Final data collection date for primary outcome measure)
Overall Response Rate (ORR) [ Time Frame: 8 weeks ]
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.
Same as current
Complete list of historical versions of study NCT01198028 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Study of Erlotinib in the Treatment of Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (CSCC) of the Skin
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
The goal of this clinical research study is to learn if erlotinib can help to control squamous cell carcinoma that has either come back or has spread. The safety of this drug will also be studied.

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 growing.

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 Maalox.

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 dose.

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.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Skin Cancer
Drug: Erlotinib
150 mg by mouth for 8 weeks.
Other Names:
  • OSI-774
  • Tarceva
  • Erlotinib hydrochloride
Experimental: Erlotinib
Erlotinib 150 mg by mouth for 8 weeks.
Intervention: Drug: Erlotinib
Gold KA, Kies MS, William WN Jr, Johnson FM, Lee JJ, Glisson BS. Erlotinib in the treatment of recurrent or metastatic cutaneous squamous cell carcinoma: A single-arm phase 2 clinical trial. Cancer. 2018 May 15;124(10):2169-2173. doi: 10.1002/cncr.31346. Epub 2018 Mar 26.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
Same as current
March 2019
March 2019   (Final data collection date for primary outcome measure)

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 </= 2 x institutional upper limit of normal (ULN) (f) AST(SGOT)/ALT(SGPT) </= 2.5 x ULN if alkaline phosphatase is normal, or alkaline phosphatase </= 4 x ULN if transaminases are normal (g) Creatinine </= 2.0 x 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 erlotinib.
  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).
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
NCI-2010-02074 ( Registry Identifier: NCI CTRP )
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
OSI Pharmaceuticals
Principal Investigator: Bonnie S. Glisson, MD, BS M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP