Brief Title
RAD001 in Recurrent Endometrial Cancer Patients
Official Title
A Phase II Study of RAD001 in Patients With Recurrent Endometrial Cancer
Brief Summary
The goal of this clinical research study is to learn if RAD001 can shrink or slow the growth
of tumors in patients who have recurrent endometrial cancer. The safety of this drug will
also be studied.
Objectives:
Primary Objective:
1. To determine the efficacy of RAD001 in patients with progressive or recurrent endometrial
cancer.
Secondary Objective:
1. To determine the nature and degree of toxicity of RAD001 in this cohort of patients.
2. To characterize, in pre- and post- treatment tumor samples, when available, expression
levels of total and phosphorylated mTOR (mammalian "target of rapamycin") as well as
relevant upstream and downstream signaling components (optional).
Detailed Description
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. Anderson.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Number of Participants With Objective Response Plus Stable Disease Rate (CR + PR + SD)
Condition
Endometrial Cancer
Intervention
RAD001
Study Arms / Comparison Groups
RAD001
Description: RAD001 10 mg by mouth Daily
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
35
Start Date
June 2004
Completion Date
January 2015
Primary Completion Date
January 2015
Eligibility Criteria
Inclusion Criteria:
1. Histologically confirmed progressive or recurrent endometrial cancer (endometrioid or
mixed with endometrioid component histology; any grade).
2. Patients may have failed no more than two prior chemotherapies for the recurrent
disease (does not include chemosensitizing radiation).
3. All patients must have measurable disease. Measurable disease is defined as lesions
that can be measured by physical examination or by means of imaging techniques.
Ascites and pleural effusions are not considered measurable disease.
4. Patients must have a pretreatment granulocyte count (i.e., segmented neutrophils +
bands) of >/=1,500/Fl, a hemoglobin level of >/=9.0 gm/dL and a platelet count of
>/=100,000/Fl.
5. Patients must have an adequate renal function as documented by serum creatinine /= grade 2 hypercholesterolemia or hypertriglyceridaemia (fasting
state), despite lipid lowering therapy should be excluded from entering the study.
12. Patients currently taking any of the medications listed in Appendix A (Patients will
be given a listing of these medications at the time of the informed consent).
13. Known hypersensitivity to everolimus, sirolimus or excipients including
hydroxytoluene, magnesium stearate, hydroxypropylmethyl-cellulose, crospovidone and
lactulose.
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Karen H. Lu, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00087685
Organization ID
2004-0002
Secondary IDs
NCI-2012-01308
Responsible Party
Sponsor
Study Sponsor
M.D. Anderson Cancer Center
Study Sponsor
Karen H. Lu, MD, Principal Investigator, M.D. Anderson Cancer Center
Verification Date
January 2016