Clinical trial NCT01413750 (phase 1/phase 2, status: terminated)
Conditions: stage iiia non-small cell lung cancer, stage iiib non-small cell lung cancer, stage iv non-small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: paclitaxel, carboplatin, vorinostat
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, N[C@@H](CCCNC(N)=N)C(O)=O, ONC(=O)CCCCCCC(=O)NC1=CC=CC=C1
Reason stopped: 
    slow accrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically confirmed non-small cell lung cancer

          -  No prior chemotherapy for advanced or metastatic disease

          -  ECOG performance status 0 or 1

          -  Patients must have measurable disease, defined as at least one lesion that can be
             accurately measured in at least one dimension (longest diameter to be recorded) as >=
             20 mm with conventional techniques or as >= 10 mm with spiral CT scan

          -  Life expectancy of greater than 12 weeks

          -  Leukocytes >= 3,000/mcL

          -  Absolute neutrophil count >= 1,500/mcL

          -  Platelets >= 100,000/mcL

          -  Total bilirubin within normal institutional limits

          -  AST(SGOT)/ALT(SGPT) =< 2.5 x institutional upper limit of normal

          -  Creatinine within normal institutional limits OR creatinine clearance >= 60
             mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Patients who have had chemotherapy or radiotherapy in a metastatic setting

          -  Patients may not be receiving any other investigational agents

          -  Patients with untreated brain metastases should be excluded from this clinical trial;
             however, patients who have stable brain disease (should be off corticosteroids) at
             least 3 weeks after completion of appropriate therapy are eligible

          -  Patients who have received any prior HDAC inhibitor (except valproic acid for seizure
             control provided that the valproic acid has been stopped at least 30 days before
             beginning therapy on this protocol) are excluded from this study

          -  Peripheral neuropathy of severity greater than grade 1

          -  Known history of allergic reactions to paclitaxel

          -  Prior therapy with paclitaxel

          -  Inability to take oral medications on a continuous basis; patients unable to swallow
             the vorinostat capsules whole are ineligible (the capsules cannot be crushed or
             broken)

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Pregnant women are excluded from this study; breastfeeding should be discontinued if
             the mother is treated with vorinostat; women of childbearing potential must use an
             appropriate double barrier method of birth control (such as female use of a diaphragm,
             intrauterine device [IUD], sponge and spermicide, in addition to the male use of a
             condom) or a prescribed birth control implant or practice abstinence; both double
             barrier contraception and implants must be used for at least one week prior to the
             start of the research study and continue for at least two weeks following the last
             study visit; please note that birth control pills should not be used while on this
             study as they may have a negative interaction with the experimental drug in this study

          -  HIV-positive patients receiving combination antiretroviral therapy are ineligible