Clinical trial NCT00831480 (phase 2, status: terminated)
Conditions: kidney cancer
ICD codes: D17.71, D30.00, D30.01, D30.02, D41.00, D41.01, D41.02
Drugs: everolimus
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
Reason stopped: 
    difficulty in accrual and by the order of the cancer center.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Advanced (metastatic) RCC

          -  Histology: clear cell, papillary or chromophobe

          -  3 out 6 risk factors (by Memorial Sloan Kettering Cancer Center criteria and one
             additional criterion: multiple sites of metastasis) or not candidates for or refuse
             sunitinib.

          -  Must have at least one measurable metastatic site according to Response Evaluation
             Criteria In Solid Tumors (RECIST) criteria that has not been previously irradiated.

          -  Must be deemed surgical candidates for cytoreductive nephrectomy by the urologist.

          -  Age 18 years of age or older

          -  Eastern Cooperative Oncology Group (EGOG) PS 0-2

          -  Adequate bone marrow function

          -  Adequate liver function as shown by:

          -  Adequate renal function

          -  Fasting serum cholesterol AND fasting triglycerides within normal limits

          -  Signed informed consent

        Exclusion Criteria:

          -  Collecting duct, medullary histologies or sarcomatoid differentiation.

          -  Central Nervous System (CNS) or leptomeningeal metastases.

          -  Inappropriate candidates for cytoreductive nephrectomy or who have any severe and/or
             uncontrolled medical conditions or other conditions that could affect their
             participation in the study

          -  severely impaired lung function

          -  uncontrolled diabetes

          -  active (acute or chronic) or uncontrolled severe infections

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

          -  Ineligible for cytoreductive nephrectomy

          -  Current or prior systemic anticancer therapies (including chemotherapy, antibody based
             therapy, or investigational drugs)

          -  Other malignancies within the past 3 years except for localized carcinoma of the
             cervix, basal or squamous cell carcinomas of the skin, or localized prostate cancer
             with Gleason Score less than 7 treated with radiation or surgery and no evidence of
             progression.

          -  Major surgery (defined as requiring general anesthesia) or significant traumatic
             injury within 4 weeks of start of enrollment

          -  Anticipated major surgery (other than CN) during the course of the study

          -  A known history of HIV seropositivity

          -  Hepatitis C seropositivity

          -  Chronic, systemic treatment with corticosteroids or another immunosuppressive agent.
             Topical or inhaled corticosteroids are allowed.

          -  Immunization with attenuated live vaccines within one week of study entry or during
             study period

          -  Known hypersensitivity to RAD001 (everolimus) or other rapamycins or to its excipients

          -  Impairment of gastrointestinal function or gastrointestinal disease

          -  Active, bleeding diathesis

          -  Female patients who are pregnant or breast feeding, or adults of reproductive
             potential who are not using effective birth control methods.

          -  History of noncompliance to medical regimens

          -  Unwilling to or unable to comply with the protocol including mandated biopsies