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A Phase II Study of RAD001 in Patients With Recurrent Endometrial Cancer

Phase 2
Open (Enrolling)
Endometrial Cancer

Thank you

Trial Information

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.

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

5. Patients must have an adequate renal function as documented by serum creatinine

6. Patients must have adequate hepatic function as documented by a serum bilirubin
tumor. Aspartate transaminase (SGOT) must be normal unless the liver is involved with tumor, in that case the aspartate
transaminase must be
7. Patients must have a Zubrod performance status of 0, 1, or 2.

8. Patients must have signed an approved informed consent.

Exclusion Criteria:

1. Patients who have previously received RAD001 or another mTOR inhibitor.

2. Patients whose tumors have serous carcinomas, mixed malignant mullerian tumors (MMMT)
components or uterine sarcomas.

3. Patients who have isolated recurrences (vaginal, pelvic, or para-aortic) that are
amenable to potentially curative treatment with radiation therapy or surgery.

4. Patients with a history of psychiatric disorders that would interfere with consent or

5. Patients with a history of myocardial infarction within the previous six months or
congestive heart failure requiring therapy.

6. Patients with a history of prior malignancy (except for adequately treated basal cell
or squamous cell skin cancer, in situ cervical cancer) or other cancer for which the
patient has been disease-free for at least five years.

7. Pregnant or lactating women. Women of reproductive potential may not participate
unless they have agreed to use an effective contraceptive method.

8. Patients with a history of seizures are ineligible. Patients receiving phenytoin,
phenobarbital, or other anti-epileptic prophylaxis are ineligible.

9. Patients with any other severe concurrent disease which would make the patient
inappropriate for entry into this study, including significant hepatic, renal, or
gastrointestinal diseases.

10. Patients with deep venous or arterial thrombosis (including pulmonary embolism)
within 6 weeks of study entry.

11. Patients with >/= 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To learn if RAD001 can shrink or slow the growth of tumors in patients who have recurrent endometrial cancer.

Outcome Time Frame:

4 Years

Safety Issue:


Principal Investigator

Karen H. Lu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2004

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • Recurrent Endometrial Cancer
  • Endometrial
  • Endometrioid
  • RAD001
  • Uterine Cancer
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma



UT MD Anderson Cancer Center Houston, Texas  77030