Ridaforolimus in Treating Patients With Recurrent Metastatic and/or Locally Advanced Endometrial Cancer

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