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
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate (ORR)
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.
8 weeks
Yes
Kathryn A. Gold, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2009-0888
NCT01198028
March 2011
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |