Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Carcinoma

Skin Neoplasms

Carcinoma, Squamous Cell

Aggression

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Mitogens

Tyrosine Kinase Inhibitors

Erlotinib Hydrochloride

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

150 mg daily by mouth before surgery and/or radiation therapy (Induction Treatment); and after surgery and/or radiation erlotinib for up to 1 year (Maintenance Phase).

Erlotinib

Bonnie S. Glisson, MD, BS

The goal of this clinical research study is to learn if Tarceva ® (erlotinib) when taken before and after radiation and/or surgery can help to control aggressive cutaneous squamous cell carcinoma. The safety of the drug will also be studied.

Erlotinib 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 Treatment/Study Drug Administration:

If you are found to be eligible to take part in this study, you will take erlotinib before surgery and/or radiation therapy (Induction Treatment). After surgery and/or radiation you will take erlotinib for up to 1 year (Maintenance Phase).

Induction Treatment:

You will take erlotinib 1 time every day, by mouth, with a full glass of water.

You will take erlotinib at about the same time every day. If you miss a dose and there is at least 12 hours before the next dose is due, you will need to take the missed dose. You should then take your next dose as scheduled. If you vomit after taking the tablet, the dose should be replaced only if the tablet can actually be seen. Erlotinib should be taken 1 hour before and 2 hours after meals and other drugs.

If you have side effects from erlotinib, the study doctor may lower your dose.

When you stop taking erlotinib during induction will depend on if the disease gets worse, if the doctor thinks you are benefitting, and if you will receive surgery and/or radiation.

You will take erlotinib for up to 10 weeks before starting local therapy. If the doctor thinks you are benefitting, you may take erlotinib for longer than 10 weeks before starting surgery and/or radiation. If the disease gets worse before 10 weeks, you will stop taking erlotinib and have surgery and/or radiation right away.

Surgery/Radiation:

During Week 4, the doctor will decide if the disease is resectable or unresectable and will schedule the type of local therapy (surgery and/or radiation) that you will receive. If You will sign separate consents for the surgery and/or radiation, which will describe the procedure(s) and the risks in detail.

Resectable Disease:

If the disease is resectable, you will be scheduled to have surgery. If the doctor thinks it is needed, you may have radiation therapy after the surgery. Radiation therapy usually will start 4-8 weeks following your surgery, if the surgical site has healed.

You will take erlotinib until 7 days before your surgery.

Unresectable Disease:

If the disease is unresectable, you will be scheduled to have radiation therapy.

You will take erlotinib until you begin the radiation therapy. If your doctor thinks you are benefiting from erlotinib, you will continue taking it during the radiation therapy.

After you complete your radiation therapy, if the doctor thinks it is needed, you will have surgery.

Maintenance Treatment:

You will restart erlotinib at 4-8 weeks after surgery, if the surgical site has healed. If you have radiation therapy after the surgery, you will take erlotinib during the radiation treatment.

If you only received radiation therapy, you will continue erlotinib after you finish your radiation therapy.

You will take erlotinib by mouth every day for up to 1 year.

Study Visits:

Induction Therapy:

On Day 1 before Induction Therapy and then every 2 weeks:

* You will be asked be asked about any side effects you may have had and any drugs you may be taking.
* You will have a physical exam, including measurement of your vital signs and weight.
* 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.
* The tumor will be measured by physical exam using rulers and/or calipers.
* Pictures will be taken of the same areas that were photographed during screening.
* If you are taking anti-coagulant medication, blood (about 1-2 teaspoons) will be drawn to check your blood clotting function.
* If your doctor thinks it is needed, you will have an ECG.

After Week 4, you will have a CT scan or MRI scan to check the status of the disease. If you continue taking erlotinib for at least 4 more weeks (a total of 8 weeks) before surgery or radiation is started, the CT or MRI will be repeated then.

After Week 4 and within 14 days before you start maintenance therapy, you will complete questionnaires about how you are feeling and your overall quality of life. The questionnaires will take about 10-15 minutes total to complete.

Maintenance Therapy:

On Day 1 before Maintenance Therapy and then every 8 weeks:

* You will be asked about any side effects you have had and any drugs you may be taking.
* You will have a physical exam, including measurement of your vital signs and weight.
* You will be asked about your smoking status.
* Your performance status will be recorded.
* The tumor will be measured.
* Pictures will be taken of the same areas that were photographed during screening.
* If the doctor thinks it is needed, you will have a CT scan or MRI scan to check the status of the disease.
* If your doctor thinks it is needed, you will have an ECG
* Blood (about 2-3 teaspoons) will be drawn for routine tests, including tests to check your blood clotting function (Day 1 only).
* If you are taking anti-coagulant medication, blood (about 2-3 teaspoons) will be drawn to check for blood clotting function (every 8 weeks only).

After Weeks 24 and 52, you will complete the questionnaires about how you are feeling and your overall quality of life.

If you only received radiation therapy, you will have a CT scan or MRI scan 3 months after the radiation therapy.

Length of Study:

You will take the study drug for up to 1 year after the surgery/radiation. You will be taken off study if the disease gets worse, if you have intolerable side effects, or if the doctor thinks it is in your best interest to stop.

End-of-Treatment Visit:

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

* You will be asked about any side effects you may have had 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.
* Blood (about 2-3 teaspoons) will be drawn for routine tests.
* If the doctor thinks it is needed, you will have a CT scan or MRI to check the status of the disease.

Long-Term Follow-Up:

After the end-of-treatment visit, you will be contacted every 3 months during Year 1 and every 6 months during Years 2 and 3 to collect information about how you are doing, any treatment you have received, and any other side effects you have experienced. You (or your family members or designees) may be contacted by telephone, in writing, by e-mail, or during clinic visits. This information may also be collected by checking your medical record. This follow-up will also consist of a physical exam if you are being seen at MD Anderson for your follow-up.

This is an investigational study. Erlotinib is FDA approved and commercially available for the treatment of non-small cell lung cancer. It is investigational to give erlotinib before and after radiation and/or surgery for the treatment of aggressive cutaneous squamous cell carcinoma.

Up to 25 patients will take part in this study. All will be enrolled at MD Anderson.

Phase II Trial of Erlotinib, Prior to Surgery or Radiation in Patients With Squamous Cell Cancers (SCC) of the Skin

Phase II Trial of Erlotinib, a Small Molecule Tyrosine Kinase Inhibitor of EGFR, Prior to Surgery or Radiation in Patients With Aggressive Squamous Cell Cancers (SCC) of the Skin

Response Evaluation Criteria In Solid Tumors (RECIST) criteria for CR = complete response, PR = partial response, SD = stable disease, PD = progressive disease, and NE = inevaluable. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): \>30% decrease in sum of diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): \>20% increase in sum of diameters of target lesions, reference smallest sum on study (this includes baseline sum if is smallest on study). In addition to relative increase of 20%, sum must absolute increase at least 5 mm. (Note: appearance of 1/\> new lesions also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum diameters while on study. Not evaluable (NE): Inevaluable when no imaging/measurement done

OSI Pharmaceuticals

M.D. Anderson Cancer Center

150 mg daily orally before surgery and/or radiation therapy (Induction Treatment); and after surgery and/or radiation erlotinib for up to 1 year (Maintenance Phase).

Spots Global Cancer Trial Database for small molecule tyrosine kinase inhibitor