Clinical trial NCT00892801 (phase 1, status: terminated)
Conditions: lung cancer, metastatic cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: rad001
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](O)[C@@H](C1)OC
Reason stopped: 
    terminated due to low accrual. study was closed to accrual prematurely and did not continue on
    to phase ii.
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Radiographically confirmed brain metastases with histopathologically confirmed primary
             non-small cell lung cancer that will benefit from whole-brain radiotherapy

          -  Must have ≥ 1 measurable intracranial site of disease, according to RECIST criteria,
             that has not been previously treated with stereotactic radiation

          -  Must have stable extracranial disease for 4 weeks

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Life expectancy ≥ 12 weeks

          -  ANC > 1,500/mm³

          -  Platelets > 100,000/mm³

          -  Hemoglobin > 11 g

          -  BUN ≤ 25 mg

          -  Serum creatinine < 1.5 times upper limit of normal (ULN)

          -  Serum bilirubin ≤ 1.5 times ULN

          -  Serum transaminases ≤ 2 times ULN (< 5 times ULN if patient has liver metastases)

          -  Cholesterol ≤ 300 mg/dL

          -  Triglycerides ≤ 2.5 times ULN

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for ≥ 3 months after
             completion of study treatment

          -  No other malignancies within the past 3 years, except for adequately treated carcinoma
             in situ of the cervix or basal or squamous cell carcinomas of the skin

          -  No severe and/or uncontrolled medical conditions or other conditions that could affect
             participation in the study, including any of the following:

               -  Unstable angina pectoris, symptomatic congestive heart failure, myocardial
                  infarction within the past 6 months, or serious uncontrolled cardiac arrhythmia

               -  Severely impaired lung function (i.e., FEV1 < 0.8 cc)

               -  Uncontrolled diabetes as defined by fasting serum glucose ≥ 1.5 times ULN

               -  Any active (acute or chronic) or uncontrolled infection/disorders

               -  Non-malignant medical illnesses that are uncontrolled or whose control may be
                  jeopardized by the treatment with the study therapy

               -  Liver disease, such as cirrhosis, chronic active hepatitis, or chronic persistent
                  hepatitis

          -  No known history of HIV seropositivity

          -  No impairment of gastrointestinal function or gastrointestinal disease that may
             significantly alter the absorption of everolimus (e.g., ulcerative disease,
             uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel
             resection)

          -  No active, bleeding diathesis

          -  No known hypersensitivity to everolimus or other rapamycin (i.e., sirolimus,
             temsirolimus) or to its excipients

          -  No history of noncompliance to medical regimens

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  Recovered from the acute toxicities of any prior therapy

          -  Prior surgical resection of a brain metastasis allowed

               -  The extent of surgical resection in patients having prior resection of 1 of
                  multiple metastases shall be documented as a biopsy, subtotal resection, or total
                  resection as described by the operative report and/or post-operative imaging

          -  At least 3 weeks since prior major surgery or completion of extracranial radiation

          -  At least 3 weeks since prior and no concurrent systemic anticancer therapy, other than
             the study medications administered as part of this study protocol

          -  At least 6 weeks since prior nitrosoureas

          -  More than 1 week since prior and no concurrent immunization with attenuated live
             vaccines

          -  More than 3 weeks since prior chemotherapy

          -  No prior brain radiotherapy of any form

          -  No concurrent chronic treatment with systemic steroids or other immunosuppressive
             agents, except steroids for neurological stability following the diagnosis of brain
             metastases

          -  No prior treatment with an mTOR inhibitor

          -  No concurrent anti-vitamin K medication, except low dose coumarin

          -  No concurrent drugs or substances known to be inhibitors or inducers of the isoenzyme
             CYP3A

          -  No other concurrent investigational therapy