RAD001 in Recurrent Endometrial Cancer Patients (NCT00087685) | Clinical Trial Compass
CompletedPhase 2
RAD001 in Recurrent Endometrial Cancer Patients
United States35 participantsStarted 2004-06
Plain-language 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).
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologically confirmed progressive or recurrent endometrial cancer (endometrioid or mixed with endometrioid component histology; any grade).
. Patients may have failed no more than two prior chemotherapies for the recurrent disease (does not include chemosensitizing radiation).
. 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.
. 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.
. Patients must have an adequate renal function as documented by serum creatinine \</=2.0 mg/dL.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Objective Response Plus Stable Disease Rate (CR + PR + SD)
. Patients must have a Zubrod performance status of 0, 1, or 2.
. Patients must have signed an approved informed consent.
Exclusion criteria
. Patients who have previously received RAD001 or another mammalian target of rapamycin (mTOR) inhibitor.
. Patients whose tumors have serous carcinomas, mixed malignant mullerian tumors (MMMT) components or uterine sarcomas.
. Patients who have isolated recurrences (vaginal, pelvic, or para-aortic) that are amenable to potentially curative treatment with radiation therapy or surgery.
. Patients with a history of psychiatric disorders that would interfere with consent or follow-up.
. Patients with a history of myocardial infarction within the previous six months or congestive heart failure requiring therapy.
. 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.
. Pregnant or lactating women. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
. Patients with a history of seizures are ineligible. Patients receiving phenytoin, phenobarbital, or other anti-epileptic prophylaxis are ineligible.