Clinical trial NCT01051570 (phase 2, status: completed)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: carboplatin, rad 001, prednisone
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, [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, [H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed metastatic adenocarcinoma of the prostate

          -  Objective disease progression or rising PSA despite androgen deprivation therapy and
             antiandrogen withdrawal (when applicable)

          -  Progressed after ≥ 1 prior docetaxel-based chemotherapy regimen for metastatic disease

               -  Patients with measurable disease* must have either rising PSA, increase in size
                  of the lesion(s), or both

                    -  Patients with rising PSA as the only evidence of disease progression must
                       demonstrate a rising trend with 2 successive elevations ≥ 1 week apart

               -  Patients with no measurable disease must have a PSA ≥ 5 ng/mL or new areas of
                  bony metastases on bone scan NOTE: *There is no minimum PSA requirement for
                  patients with measurable disease

          -  Documented to be castrate with a testosterone level of ≤ 0.5 ng/mL

               -  Leuteinizing hormone-releasing hormone agonist therapy must be continued, if
                  required to maintain castrate levels of testosterone

          -  No uncontrolled brain or leptomeningeal metastases, including patients who continue to
             require glucocorticoids for brain or leptomeningeal metastases

        PATIENT CHARACTERISTICS:

          -  Zubrod performance status 0-1

          -  ANC ≥ 1,500/mm^3

          -  Hemoglobin ≥ 9.0 g/dL

          -  Platelet count ≥ 100,000/mm^3

          -  Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  Calculated creatinine clearance ≥ 50 mL/min OR serum creatinine ≤ 2 mg/dL

          -  AST and/or ALT ≤ 2.5 times ULN if alkaline phosphatase normal OR alkaline phosphatase
             ≤ 4 times ULN if AST and/or ALT normal (for patients without documented bone
             metastases or for patients with liver metastases)

          -  AST and/or ALT < 2.5 times ULN, without regard to alkaline phosphatase levels (for
             patients with documented bone metastases)

          -  Fasting serum cholesterol ≤ 300 mg/dL OR ≤ 7.75 mmol/L AND fasting triglycerides ≤ 2.5
             times ULN (in the case that one or both of these thresholds are exceeded, the patient
             is eligible only after initiation of appropriate lipid-lowering medication)

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

          -  Willing and able to comply with this study

          -  Able to ingest oral medication

          -  No other malignancies except non-melanoma skin cancer or any other adequately treated
             cancer in complete remission for ≥ 2 years

          -  No significant traumatic injury within the past 4 weeks

          -  No active (acute or chronic) or uncontrolled severe infections

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

               -  NYHA class III-IV symptomatic congestive heart failure

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

               -  Severely impaired lung function as defined by spirometry and DLCO that is 50% of
                  the normal predicted value and/or oxygen saturation that is ≤ 88% at rest on room
                  air

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

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

               -  Known history of HIV seropositivity, hepatitis B or C

               -  Impairment of gastrointestinal (GI) function or GI disease that may significantly
                  alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled
                  nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)

               -  Active, bleeding diathesis

          -  No known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus)
             or to their excipients

          -  No history of noncompliance to medical regimens

          -  No uncontrolled diabetes mellitus

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  At least 1 prior docetaxel based regimen for metastatic disease

               -  Docetaxel based combination therapy or docetaxel alone considered as 1 regimen

          -  No more than 2 prior chemotherapy regimens for metastatic disease

          -  No prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus)

          -  At least 6 weeks since prior bicalutamide or nilutamide

          -  At least 4 weeks since prior flutamide

          -  More than 4 weeks since prior and no other concurrent investigational drugs

          -  More than 4 weeks since prior and no other concurrent anticancer therapies (including
             chemotherapy, radiotherapy, or antibody-based therapy)

          -  More than 4 weeks since prior and no concurrent major surgery (defined as requiring
             general anesthesia) and recovered

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

          -  No concurrent chronic, systemic treatment with corticosteroids or other
             immunosuppressive agents

               -  Topical or inhaled corticosteroids are allowed

          -  No concurrent prophylactic growth factors

          -  Concurrent bisphosphonate therapy allowed