Clinical trial NCT00423865 (phase 1, status: completed)
Conditions: unspecified adult solid tumor, protocol specific
ICD codes: H01.009, H02.209, H02.009, H02.109, H04.209, H05.409, H10.509
Drugs: cisplatin, everolimus
SMILES: [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, [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:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed diagnosis of 1 of the following:

               -  Advanced solid tumor (part A)

                    -  Confirmation by core biopsy or fine-needle aspiration allowed

               -  Solid tumor (part B)

                    -  Recurrent or metastatic disease

                    -  Easily accessible for biopsy

          -  Measurable disease

          -  No uncontrolled brain or leptomeningeal metastases

               -  No requirement for glucocorticoids

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status 70-100%

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Hemoglobin > 10 g/dL

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  AST and ALT ≤ 2.5 times ULN (< 5 times ULN if liver metastases are present)

          -  Creatinine normal OR creatinine clearance ≥ 55 mL/min

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for at least 3 months
             after completion of study therapy

          -  No HIV positivity

          -  No peripheral neuropathy ≥ grade 2

          -  No hypertriglyceridemia ≥ grade 2

          -  No impaired gastrointestinal function or gastrointestinal disease that may alter the
             absorption of everolimus, including any of the following:

               -  Ulcerative disease

               -  Uncontrolled nausea

               -  Vomiting

               -  Diarrhea

               -  Malabsorption syndrome

               -  Small bowel resection

          -  No other concurrent severe and/or uncontrolled medical disease that would compromise
             study participation, including any of the following:

               -  Uncontrolled diabetes

               -  Unstable angina

               -  New York Heart Association class III or IV congestive heart failure

        PRIOR CONCURRENT THERAPY:

          -  No more than 3 prior cytotoxic chemotherapy regimens for recurrent or metastatic
             disease

          -  At least 4 weeks since prior major surgery and recovered

          -  At least 4 weeks since prior radiation therapy and recovered

          -  At least 4 weeks since prior systemic anticancer therapy and recovered

          -  At least 4 weeks since prior and no other concurrent investigational drugs

          -  No prior everolimus or other agents specifically targeting mTOR

          -  No prior radiation therapy to > 25% of the bone marrow

          -  No prior radiation therapy to the whole pelvis and/or brain

          -  No concurrent chronic steroid treatment (> 5 mg/day of prednisone)

               -  Concurrent low-dose steroid replacement regimens (≤ 5 mg/day of prednisone)
                  allowed

          -  No concurrent immunosuppressive agents

          -  No other concurrent anticancer agents

          -  No concurrent agents known to be strong inhibitors or inducers of isoenzyme CYP3A