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.|
|ClinicalTrials.gov Identifier: NCT01198028|
Recruitment Status : Active, not recruiting
First Posted : September 9, 2010
Last Update Posted : September 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Skin Cancer||Drug: Erlotinib||Phase 2|
Hide Detailed Description
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.
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||March 2011|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
Erlotinib 150 mg by mouth for 8 weeks.
150 mg by mouth for 8 weeks.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01198028
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Bonnie S. Glisson, MD, BS||M.D. Anderson Cancer Center|