Phase II Study of Cetuximab (Erbitux) in Patients With Progressive or Recurrent Endometrial Cancer
The epidermal growth factor receptor (EGFR) is a large protein that plays an important role
in tumor growth. When EGFR is stimulated or "overexpressed," a series of chemical reactions
happen that result in a tumor being "told" to grow. Researchers know that EGFR is
overexpressed in many types of endometrial cancer. Cetuximab is designed to block this
receptor, which may help to stop or slow the growth of tumors in those patients whose
endometrial cancer has come back.
Before you can start treatment on this study, you will have "screening tests." These tests
will help the doctor decide if you are eligible to take part in the study. If you have had
some of the tests done recently, they may not need to be repeated. Your complete medical
history will be recorded. You will have a physical exam, including a pelvic exam and
measurement of vital signs (blood pressure, heart rate, temperature, and breathing rate).
Blood (about 2-3 teaspoons) will be drawn for routine tests, tests of your kidney and liver
function, and a pregnancy test for women who are able to have children. The pregnancy test
must be negative for you to be allowed to take part in this study. You will have a chest
x-ray and computed tomography (CT) or magnetic resonance imaging (MRI) scans of the abdomen
and pelvis (stomach and hip area) to measure the tumor.
If you are found to be eligible to take part in this study, you will receive cetuximab once
a week through a needle in a vein. Each treatment cycle is 4 weeks long. In the first week
of your first treatment cycle only, you will receive cetuximab over 120 minutes (2 hours).
For all additional treatments, you will receive cetuximab over 60 minutes. During the
infusion and for 60 minutes after the infusion ends, you will be closely watched for signs
of an allergic reaction.
You will receive diphenhydramine (or a similar antihistamine) by vein, about 30-60 minutes
before receiving each cetuximab infusion. This is in order to lower the risk of side
effects that the study drug may cause. Your doctor may decide to lower the dose of
diphenhydramine in later doses.
Before each cycle of therapy and 1 month after treatment ends, you will have a physical
exam. Blood (about 2-3 teaspoons) will be drawn for routine tests. CT scans or MRI will be
repeated every 2-3 cycles and at the end of treatment. If you have any tumors in your
chest, a chest x-ray will be repeated every 2-3 cycles and at the end of treatment. If you
have a partial or complete response (the tumor shrinks or disappears completely) or the
disease is stable (where the tumor has neither grown nor shrunk), the CT or MRI will be
repeated 4 weeks later to check the response.
You will be able to keep receiving additional treatment cycles as long as you are
benefitting. If the disease gets worse or you experience any intolerable side effects, you
will be taken off the study.
After you have completed treatment on the study, the status of your health and the disease
will be checked. Your doctor will decide how often these check-ups will occur. You may
return to M. D. Anderson for these follow-up exams, or if you choose not to come in to the
clinic, you will be contacted by phone to see how you are doing.
This is an investigational study. Cetuximab is commercially available and FDA approved for
the treatment of colorectal cancer. Its use in the treatment of endometrial cancer in this
study is experimental. Up to 40 patients will take part in this study. Up to 30 patients
will be enrolled at M. D. Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Disease Control Rate
Overall disease control rate also called the Clinical Benefit Response (CBR) is defined as Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) evaluated within 8 weeks (CR or PR) and 12 weeks (SD) of initial treatment, using Bayesian design.
Overall disease control rate (CR + PR + SD) evaluated within 8 weeks (CR or PR) and 12 weeks (SD) of initial treatment.
Judith Wolf, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD . Anderson Cancer Center||Houston, Texas 77030|
|New York Presbyterian Hospital-Cornell Medical Center||New York, New York 10021|