Temsirolimus in Treating Patients With Recurrent or Persistent Cancer of the Uterus
Condition: Recurrent Uterine Sarcoma; Uterine Carcinosarcoma
MeSH terms: Carcinosarcoma; Mixed Tumor, Mullerian; Recurrence
Intervention: temsirolimus
Intervention description: Given IV
Intervention MeSH terms: Sirolimus; Temsirolimus; MTOR Inhibitors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well temsirolimus works in treating patients with
      recurrent or persistent cancer of the uterus. Temsirolimus may stop the growth of tumor cells
      by blocking some of the enzymes needed for cell growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed Carcinosarcoma (MMMT)

          -  Measurable disease;

          -  Only one prior systemic treatments after primary adjuvant treatment for persistent or
             metastatic disease are permitted,

          -  Radiation therapy (adjuvant or palliative) must be completed ≥ 4 weeks prior to
             registration

          -  Required laboratory values obtained =< 7 days prior to registration:

          -  Absolute Neutrophil Count (ANC) >= 1500/mm^3

          -  Platelets >= 75,000/mm^3

          -  Hemoglobin >= 9.0 g/dL

          -  Direct bilirubin =< 1.5 x upper limit of normal (ULN)

          -  Alkaline phosphatase =< 2.5 x ULN (≤ 5 x ULN if liver metastasis is present)

          -  SGOT(AST) =< 2.5 x ULN (≤ 5 x ULN if liver metastasis is present)

          -  Creatinine =< 1.5 x ULN

          -  Fasting serum cholesterol ≤ 350mg/dL (9.0 mmol/L)

          -  Triglycerides ≤ 1.5 x ULN

               -  Patients with Triglyceride levels > 1.5 x ULN can be started on lipid lowering
                  agents and reevaluated within 1 week; if levels go to ≤ 1.5 x ULN, they can be
                  considered for the trial and continue the lipid lowering agents

          -  International Normalized Ratio (INR) ≤ 1.5 (unless the patient is on full dose
             warfarin)

          -  ECOG Performance Status (PS) 0-1

          -  Capable of understanding the investigational nature, potential risks and benefits of
             the study and able to provide valid informed consent

          -  Full-dose anticoagulants, if a patient is receiving full-dose anticoagulants, the
             following criteria should be met for enrollment:

               -  The subject must have an in-range INR (usually between 2 and 3) on a stable dose
                  of warfarin or on stable dose of LMW heparin

          -  Patients who have had prior anthracycline must have a normal ejection fraction on LVEF
             assessment by MUGA or Echo ≤ 4 weeks prior to registration

          -  Availability of tissue samples or blocks (from the primary tumor or metastases) for
             tumor studies

          -  Willingness to donate blood for correlative marker studies

        Exclusion Criteria:

          -  Prior therapy with Temsirolimus or another mTOR inhibitors

          -  Patients cannot be receiving enzyme-inducing antiepileptic drugs (EIAEDs; e.g.,
             phenytoin, carbamazepine, phenobarbital) nor any other CYP3A4 inducer such as rifampin
             or St. John's wort

          -  Untreated central nervous system (CNS) metastases; exceptions: patients with known CNS
             metastases can be enrolled if the brain metastases have been adequately treated and
             there is no evidence of progression or hemorrhage after treatment as ascertained by
             clinical examination and brain imaging (MRI or CT) ≤ 12 weeks prior to registration
             and no ongoing requirement for steroids

               -  Anticonvulsants (stable dose) are allowed

               -  Patients who had surgical resection of CNS metastases or brain biopsy ≤ 3 months
                  prior to registration will be excluded

          -  Pregnant or lactating wome

          -  Currently active, second malignancy other than non-melanoma skin cancers; - Other
             uncontrolled serious medical or psychiatric condition (e.g. cardiac arrhythmias,
             diabetes, etc.)

          -  Active infection requiring antibiotics

          -  Received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER
             THAN for the treatment of endometrial cancer

          -  Radiation therapy to > 50% of marrow bearing areas