A Phase II Study of RAD001 in Patients With Recurrent Endometrial Cancer
RAD001 is a new drug that was designed to block proteins that are important in the
development and growth of cancer.
Before treatment starts, you will have a complete physical exam, routine blood tests (about
2-3 teaspoons), a chest x-ray, and a CT scan or MRI of the abdomen and pelvis. Women who
are able to have children must have a negative blood pregnancy test.
Routine blood tests (about 2 teaspoons) will be done weekly during treatment, and before
each course of therapy, which is every 4 weeks. A complete checkup including evaluation of
side effects, will also be done before each course of therapy and at the end of therapy (4
weeks after treatment ends).
You will take RAD001 10 mg by mouth every day. One course of therapy is 4 weeks long. RAD001
should be taken the same time every day on an empty stomach (fasting state) or after no more
than a light, fat-free meal. You should wait at least 6 hours after a eating a regular (not
fat-free meal) before taking RAD001. You should not eat fatty foods for at least one hour
after taking RAD001.
If side effects occur at this dose, your doctor may lower the RAD001 dose, depending on the
severity of the side effects. After an additional 4 weeks of therapy, if the dose was
reduced and the side effects have resolved, your doctor may increase the dose back to the
original dose, or you may continue at the reduced dose.
You will only be given the amount of drug needed for one course of therapy at a time. You
will keep a diary during the study that will list when and how much drug you took. This
diary will be reviewed after each course of therapy by the research nurse or physician and
filed in your chart.
You will have CT or MRI scans and chest x-rays (only in patients with chest disease) to
evaluate the response of your tumor to treatment. These scans will be done after the first
two courses (eight weeks) and every third course (every 12 weeks) and at the end of therapy.
Treatment will be stopped if the disease gets worse or intolerable side effects occur.
This is an investigational study. RAD001 has been authorized by the FDA for use in research
only. Up to 35 patients will take part in this study. All will be enrolled at M. D.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To learn if RAD001 can shrink or slow the growth of tumors in patients who have recurrent endometrial cancer.
Karen H. Lu, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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