Temsirolimus in Treating Patients With Metastatic or Locally Advanced Recurrent Endometrial Cancer

Inclusion Criteria

• Patients must have histologically confirmed metastatic and/or locally advanced recurrent adenocarcinoma (papillary serous, papillary, villoglandular, mucinous, clear cell), endometrioid or adenosquamous carcinoma of the endometrium, incurable by standard therapies
• Patients must have tumour tissue from their primary tumor available to assess molecular markers of CCI-779 activation (paraffin block or unstained slides)
• Presence of clinically and/or radiologically documented disease; at least one site of disease must be unidimensionally measurable as follows:
• X-ray, physical exam >= 20 mm
• Spiral computed tomography (CT) scan >= 10 mm
• Non-spiral CT scan >= 20 mm
• All radiology studies must be performed within 28 days prior to registration (within 35 days if negative)
• Patients must have a life expectancy of at least 12 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2
• Previous therapy:
• Hormonal therapy:
• Group A: One prior hormonal treatment (progestational or aromatase inhibitor) as either adjuvant therapy or for treatment of metastatic disease
• Group B: No limit to number of prior hormonal treatments given (progestational or aromatase inhibitor) as either adjuvant therapy or for treatment of metastatic disease
• Time since last hormone: >= 1 week since last dose of hormonal therapy (applies to both Groups)
• Chemotherapy:
• Group A: No prior chemotherapy
• Group B: Patients must have had one prior regimen of chemotherapy for metastatic disease; patients must be 4 weeks since last dose of chemotherapy
• Radiation: Patients may have had prior radiation therapy; a minimum of 28 days must have elapsed between the end of radiotherapy and registration onto the study; (exceptions may be made however, for low dose, palliative radiotherapy; patients must have recovered from any acute toxic effects from radiation prior to registration
• Previous surgery: Previous major surgery is permitted provided that it has been at least 21 days prior to patient registration and that wound healing has occurred
• Granulocytes (absolute granulocyte count [AGC]) >= 1.5 x 10^9/L
• Platelets >= 100 x 10^9/L
• Bilirubin = = 50 ml/min; creatinine clearance to be measured directly by 24 hour urine sampling or as calculated by Cockcroft Formula
• Fasting serum cholesterol = = 5 years
• Patients must not have had prior treatment with an mammalian target of rapamycin (mTOR) inhibitor
• Uterine sarcomas (leiomyosarcoma), mixed mullerian tumours (MMT) and/or adenosarcomas
• Patients with non-measurable disease only; (please note that bone metastases are considered non-measurable)
• Pregnant or lactating women; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with CCI-779; most patients enrolled on this trial will have had a prior hysterectomy or pelvic irradiation; however, if the patient is of childbearing potential, a urine beta-human chorionic gonadotropin (HCG) must be proved negative within 7 days prior to registration; women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Patients with known brain metastases; (a head CT is not necessary to rule out brain metastases, unless there is clinical suspicion of central nervous system [CNS] involvement)
• Patients with serious cardiovascular illness such as myocardial infarction within 6 months prior to entry, congestive heart failure (even if medically controlled), unstable angina, active cardiomyopathy, unstable ventricular arrhythmia or uncontrolled hypertension
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to CCI-779
• Patients receiving concur