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

2014-07-24 14:10:09 | BioPortfolio

Summary

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.

The primary objective is to:

Determine the response rate to induction therapy with erlotinib 150 mg/day in patients with aggressive squamous cell carcinoma of the skin who are planned for definitive local surgery or radiation therapy.

Secondary objectives are to determine:

- The early progression rate; that is, progression during erlotinib induction.

- The feasibility and safety of induction erlotinib (for all patients) and concomitant erlotinib with radiotherapy (for unresectable patients).

- The incidence of second primary Cutaneous Squamous Cell Carcinoma (CSCC)s while on study.

- The frequency and timing of local and distant failures.

Description

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.

Screening Tests:

Before you can be enrolled on this study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. The following tests and procedures will be performed:

- Your complete medical history will be recorded.

- You will complete questionnaires about your smoking history, how you are feeling, and your overall quality of life. The questionnaires should take about 10-20 minutes total to complete.

- You will have a physical exam, including measurements of your height, weight, and vital signs (blood pressure, heart rate, temperature, and breathing rate).

- Blood (about 2-3 teaspoons) will be drawn for routine tests, including tests to check your blood clotting function. This routine blood collection will include a pregnancy test for women who are able to become pregnant. To take part in this study, the pregnancy test must be negative.

- You will be asked how well you are able to perform the normal activities of daily living (performance status).

- You will be asked about any drugs you may be taking.

- You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart).

- You will have a computed tomography (CT) scan or MRI scan and chest x-ray to check the status of the disease.

- The tumor will be measured by physical exam using rulers and/or calipers. Photographs will be taken of the disease site and 2 other sites that are at risk for Actinic Keratoses (pre-cancerous growth on the skin). Your private areas will be covered (as much as possible), and a picture of your face will not be taken unless there are lesions on your face.

The study doctor will discuss the screening test results with you. If the screening tests show that you are not eligible to take part in the study, you will not be enrolled. Other treatment options will be discussed with you.

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. 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 8, 16, 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 M. D. Anderson for your follow-up.

Additional Information Avoid taking drugs that will decrease stomach acid while taking erlotinib. These drugs include Zantac® (ranitidine), Pepcid® (famotidine), Tagamet® (cimetidine), Protonix® (pantoprazole), Nexium® (esomeprazole), Prilosec® (omeprazole), Prevacid® (pantoprazole), and Aciphex® (rabeprazole).

Short-acting antacids (such as Tums®, Maalox®, Mylanta®, Rolaids®) may be taken while on erlotinib, as long as they are not taken 2 hours before or after your dose of erlotinib.

Erlotinib hydrochloride may interact with warfarin (Coumadin®), a drug used to decrease blood clotting. You should inform your doctor if you are taking this drug. Erlotinib hydrochloride may also interact with certain other medications/ substances. These include Diflucan (fluconazole), erythromycin, St. John's wort, and grapefruit juice. Because of these interactions, and others that are not listed here, you should tell the study doctor about all medications, herbal remedies, vitamins, and supplements you may be taking.

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 40 patients will take part in this study. All will be enrolled at M. D. Anderson

Study Design

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

Conditions

Skin Cancer

Intervention

Erlotinib

Location

UT MD Anderson Cancer Center
Houston
Texas
United States
77030

Status

Not yet recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:10:09-0400

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