Ridaforolimus in Treating Patients With Recurrent Metastatic and/or Locally Advanced Endometrial … (NCT00770185) | Clinical Trial Compass
CompletedPhase 2
Ridaforolimus in Treating Patients With Recurrent Metastatic and/or Locally Advanced Endometrial Cancer
Canada35 participantsStarted 2008-11-13
Plain-language summary
RATIONALE: Ridaforolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying the side effects of ridaforolimus and to see how well it works in treating patients with recurrent metastatic and/or locally advanced endometrial cancer.
Who can participate
Age range
18 Years
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.
DISEASE CHARACTERISTICS:
* Histologically confirmed endometrial cancer, including any 1 of the following subtypes:
* Adenocarcinoma
* Papillary serous
* Papillary
* Villoglandular
* Mucinous
* Clear cell
* Endometrioid
* Adenosquamous carcinoma
* Recurrent or metastatic and/or locally advanced disease
* Incurable disease by standard therapies
* Clinically and/or radiologically documented disease within the past 28 days (35 days if negative), defined as ≥ 1 unidimensionally measurable disease site meeting 1 of the following criteria:
* At least 20 mm by x-ray or physical exam
* At least 10 mm by spiral CT scan
* At least 20 mm by non-spiral CT scan
* Available tumor tissue (paraffin block or unstained slides) from primary tumor
* No uterine sarcoma (leiomyosarcoma), mixed müllerian tumor (MMT), and/or adenosarcoma
* No known brain metastases
* Clinical suspicion of CNS involvement requires a head CT scan
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 12 weeks
* Granulocyte count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Bilirubin ≤ upper limit of normal (ULN)
* ALT and AST ≤ 2.5 times ULN
* Creatinine ≤ 1.25 times ULN OR creatinine clearance ≥ 50 mL/min
* Fasting serum cholesterol ≤ 9.0 mmol/L
* Fasting triglycerides ≤ 4.56 mmol/L
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Accessible for treatment and follow up (e.g., 1 ½ hours driving distance…
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
Objective response measured by RECIST criteria
Timeframe: every 8 weeks
2
Adverse events
Timeframe: 4 years
3
Time to progression
Timeframe: 4 years
4
Correlation between objective tumor response with PTEN expression and other potential markers