Could a targeted drug shrink recurrent endometrial tumors?
NCT ID NCT00087685
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This phase II trial tests whether the drug RAD001 can shrink or slow the growth of tumors in people with recurrent endometrial cancer. Participants take RAD001 daily by mouth. The study measures how many patients have their tumors shrink or stay stable, and also tracks side effects. It includes people who have had up to two prior chemotherapies for their recurrent disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RAD001 (everolimus)
- What this could lead to
- If successful, this could offer a new treatment option for people with recurrent endometrial cancer who have limited chemotherapy choices.
- What could go wrong
- This is an early-phase trial with only 35 participants, so results may not apply broadly. The drug may cause side effects and might not shrink tumors in all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
35 people
The number who actually took part.
- Start date
-
Jun 2004
- Finished
-
Jan 2015
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 \</=2.0 mg/dL. 6. Patients must have adequate hepatic function as documented by a serum bilirubin \</=1.5 mg/dL, regardless of whether patients have liver involvement secondary to tumor. Aspartate transaminase (SGOT) must be \</=3x institutional upper limit of normal unless the liver is involved with tumor, in that case the aspartate transaminase must be \</=5x institutional upper limit of normal. 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 mammalian target of rapamycin (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 follow-up. 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 lactulose.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
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