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 range18 Years
SexFEMALE
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…
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