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This study evaluates the drug Ridaforolimus in patients with recurrent, metastatic, or locally advanced endometrial cancer (cancer of the uterine lining) that is incurable with standard therapies. It included patients with confirmed, measurable disease. It was a Phase 2 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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 from participating center)
* No upper gastrointestinal or other condition that would impair swallowing or absorption of oral medication
* No serious illness or medical condition that would not permit the patient to be managed according to the protocol, including, but not limited to, any of the following:
* History of significant neurologic or psychiatric disorder (e.g., uncontrolled psychotic disorders) that would impair the ability to obtain consent or limit compliance with study requirements
* Active uncontrolled or serious infection
* Active peptic ulcer disease
* Myocardial infarction within the past 6 months, congestive heart failure (even if medically controlled), unstable angina, active cardiomyopathy, unstable ventricular arrhythmia, or uncontrolled hypertension
* Pulmonary disease requiring oxygen
* HIV infection or other immune deficiency
* Other medical conditions that might be aggravated by study treatment
* No history of other malignancies, except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years
* No known hypersensitivity to the study drug or its components
PRIOR CONCURRENT THERAPY:
* At least 7 days since prior hormonal therapy (progestational or aromatase inhibitor) as either adjuvant therapy or for treatment of metastatic disease
* At least 21 days since prior major surgery and recovered
* At least 28 days since prior radiotherapy and recovered
* Prior low-dose palliative radiotherapy allowed
* At least 4 months since prior adjuvant chemotherapy
* No prior mTOR inhibitors
* No prior or concurrent chemotherapy for metastatic or recurrent disease
* More than 7 days since prior and no concurrent CYP3A4 inhibitors including, but not limited to, any of the following:
* Azole antifungals (i.e., ketoconazole, itraconazole, miconazole, fluconazole)
* HIV protease inhibitors (i.e., indinavir, saquinavir, ritonavir, atazanavir, nelfinavir)
* Clarithromycin
* Verapamil
* Erythromycin
* Delavirdine
* Diltiazem
* Nefazodone
* Telithromycin
* More than 12 days since prior and no concurrent CYP3A4 inducers including, but not limited to, any of the following:
* Rifampin
* Phenytoin
* Rifabutin
* St. John's wort
* Carbamazepine
* Efavirenz
* Phenobarbital
* Tipranavir
* At least 14 days since prior and no concurrent investigational drugs or anticancer therapy (e.g., immunotherapy, biological response modifiers \[excluding hematopoietic growth factors\], and systemic hormonal therapy)
* No concurrent CYP3A4 substrates