Clinical trial NCT02188550 (phase 2, status: unknown status)
Conditions: ovarian cancer, endometrial cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, N85.00, N85.01, N85.02, N99.85
Drugs: everolimus and letrozole
SMILES: [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC
Eligibility criteria:

        Inclusion Criteria:

          -  Post-menopausal or post-oophorectomy.

          -  Performance status Less than or equal to ECOG 2

          -  Patients must have relapse or refractory or persistent epithelial ovarian, fallopian
             tube, primary peritoneal carcinoma or endometrial cancer. Histologic documentation of
             the original primary tumor is required via pathology report.

          -  Patients must have received treatment with a platinum-based chemotherapeutic regimen
             for management of primary disease containing carboplatin, cisplatin. This initial
             treatment may have included intraperitoneal therapy, consolidation, noncytotoxic
             agents (biologic/targeted therapy) or extended therapy administered after surgical or
             non-surgical assessment.

          -  Patients must have platinum-resistant disease, defined as progression < 12 months
             after completion of first-or-second-line platinum based chemotherapy. The date
             (platinum-free interval) should be calculated from the last administered dose of
             platinum therapy.

          -  Platinum sensitive patients must have progressed/relapsed after receiving a second
             line platinum therapy.

          -  Patients with platinum-refractory primary disease, defined as having disease3
             progression while receiving first-line platinum-based chemotherapy.

          -  Patients are allowed to receive, but are not required to receive, one additional
             cytotoxic regimen for management of relapse or refractory or persistent disease.

          -  Patients are allowed to have received, but are not required to have received,
             biologic/targeted therapy (e.g., bevacizumab and/or PARP inhibitor) as part of their
             primary treatment regimen or for management of relapse or refractory or persistent
             disease.

        Exclusion Criteria:

          -  Patients currently receiving anticancer therapies or who have received anticancer
             therapies within 4 weeks of the start of Everolimus (including chemotherapy, antibody
             based therapy, etc.); radiation therapy within 2 weeks.

          -  Known intolerance or hypersensitivity to Everolimus or other rapamycin analogs (e.g.

        sirolimus, temsirolimus) or to Letrozole.

          -  Known impairment of gastrointestinal (GI) function or GI disease that may
             significantly alter the absorption of oral Everolimus;

          -  Patients who have any severe and/or uncontrolled medical conditions such as:

               1. unstable angina pectoris, symptomatic congestive heart failure, myocardial
                  infarction ≤6 months prior to start of Everolimus, serious uncontrolled cardiac
                  arrhythmia, or any other clinically significant cardiac disease

               2. Symptomatic congestive heart failure of New York heart Association Class III or
                  IV

               3. active (acute or chronic) or uncontrolled severe infection, liver disease such as
                  cirrhosis, decompensated liver disease, and active or chronic hepatitis (i.e.
                  quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA),

               4. known severely impaired lung function (spirometry and DLCO 50% or less of normal
                  and O2 saturation 88% or less at rest on room air),

               5. active, bleeding diathesis;

          -  Chronic treatment with corticosteroids or other immunosuppressive agents. Topical or
             inhaled corticosteroids are allowed;