Clinical trial NCT00526591 (phase 2, status: terminated)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
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: 
    slow accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed newly diagnosed, localized adenocarcinoma of
             the prostate, meeting any of the following criteria:

               -  Clinical stage T2a, T2b, T2c, or T3 disease (any grade or PSA)

               -  Gleason score 7 (4+3 only) or ≥ 8 (any stage or PSA)

               -  Serum PSA ≥ 10 ng/dL (any grade or stage)

               -  Any stage, PSA, or Gleason score AND ≥ 35% chance of biochemical failure at 5
                  years based on Kattan's nomogram

          -  Recommended for radical prostatectomy

          -  Normal testosterone level

          -  No pure neuroendocrine or small cell prostate cancer

          -  No metastatic disease by CT scan, MRI, bone scan, or X-ray

          -  No clinical evidence of CNS metastases

        PATIENT CHARACTERISTICS:

        Inclusion criteria:

          -  ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%

          -  ANC ≥ 1,500/μL

          -  Platelet count ≥ 100,000/μL

          -  Hemoglobin ≥ 8 g/dL

          -  AST and ALT ≤ 1.5 times upper limit of normal (ULN)

          -  Bilirubin ≤ 1.5 times ULN

          -  Creatinine ≤ 1.5 times ULN

          -  PT/PTT normal (no anticoagulants)

          -  No active unresolved infection

          -  No known HIV positivity

          -  Fertile patients must use effective contraception during and for 6 months after
             completion of study therapy

        Exclusion criteria:

          -  Known hypersensitivity to everolimus or other rapamycins (e.g., sirolimus or
             temsirolimus) or to its excipients

          -  Gastrointestinal (GI) disease, condition, or symptoms that may significantly impair GI
             function and alter the absorption of everolimus, including any of the following:

               -  Ulcerative disease

               -  Uncontrolled nausea

               -  Vomiting

               -  Diarrhea

               -  Malabsorption syndrome

          -  Other active malignancy or malignancy at ≥ 30% risk for relapse after completion of
             therapy, except nonmelanoma skin cancer

          -  Uncontrolled concurrent illness including, but not limited to, any of the following:

               -  Ongoing or active infection (e.g., bacterial, viral or fungal)

               -  Severely impaired lung function

               -  Uncontrolled diabetes (fasting serum glucose > 1.5 times ULN)

               -  Liver disease (e.g., cirrhosis, chronic active hepatitis, or chronic persistent
                  hepatitis)

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia

          -  Psychiatric illness or social situation that would limit study compliance

          -  Any underlying medical condition which, in the principal investigator's opinion, will
             make the administration of everolimus hazardous OR obscure the interpretation of
             adverse events

        PRIOR CONCURRENT THERAPY:

          -  More than 4 weeks since major surgery

          -  More than 3 months since finasteride

          -  No prior or concurrent radiotherapy to the prostate gland or pelvis

          -  No prior hormones (e.g., luteinizing hormone-releasing hormone [LHRH] agonists, LHRH
             antagonists, or antiandrogens [e.g., bicalutamide, flutamide, or nilutamide]) and/or
             PC-SPES (or PC-x product) or estrogen-containing nutraceuticals

          -  No prior rapamycin mTOR inhibitor

          -  No prior small bowel resection that may significantly impair GI function and alter the
             absorption of everolimus

          -  No prior or concurrent immunotherapy, chemotherapy, or other investigational therapy
             for prostate cancer

          -  No other concurrent investigational or commercial agents

          -  No other concurrent anticancer agents

          -  No concurrent, chronic treatment with systemic steroids (except inhaled or topical
             steroids) or another immunosuppressive agent

          -  No concurrent live vaccines

          -  No concurrent strong inhibitors or inducers of the isoenzyme CYP3A administered as
             systemic therapy