Clinical trial NCT00117351 (phase 2, status: terminated)
Conditions: carcinoma, non-small-cell lung, adenocarcinoma, bronchiolo-alveolar
ICD codes: D02.20, D02.21, D02.22
Drugs: velcade
SMILES: CN1C(CCCC(O)=O)=NC2=CC(=CC=C12)N(CCCl)CCCl
Reason stopped: 
    insufficient efficacy
  
Eligibility criteria:

        Inclusion Criteria:

          -  Have histologically or cytologically confirmed BAC or adenocarcinoma with BAC
             features.

          -  Have stage IIIB (malignant pleural effusion) or stage IV disease.

          -  Have progressed on or after receipt of 1 to 2 prior lines of chemotherapy, one of
             which must be an EGFR TKI (Iressa or Tarceva). Adjuvant chemotherapy will NOT be
             counted as a prior line of therapy.

          -  Have radiographic documentation of progressive disease (PD) as determined by the
             investigator.

          -  Have measurable disease by RECIST.

          -  Are 18 years of age or older.

          -  Have a life expectancy greater than 3 months.

          -  Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

          -  Are able to provide written informed consent in accordance with all applicable
             regulations and follow the study procedures.

          -  Patients must be capable of understanding the investigational nature and potential
             risks and benefits.

        Exclusion Criteria:

          -  Have had chemotherapy (or an EGFR TKI) 4 weeks prior to enrollment.

          -  Have peripheral neuropathy of Grade 2 or greater intensity, as defined by the National
             Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 3.0).

          -  Have been previously treated with VELCADE.

          -  Have experienced myocardial infarction within 6 months prior to enrollment or have New
             York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina,
             severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute
             ischemia or active conduction system abnormalities.

          -  Have had radiation therapy within 4 weeks prior to enrollment.

          -  Have had monoclonal antibody therapy within 4 weeks prior to enrollment.

          -  Have had any major surgery within 4 weeks prior to enrollment.

          -  Have inadequate organ function at the Screening visit as defined by laboratory testing

          -  Have symptomatic brain metastases or brain metastases that have not responded to
             radiation therapy, local or systemic chemotherapy, or were not completely resected by
             stereotactic surgery or other surgical modalities, or have significant post treatment
             brain edema.

          -  Have uncontrolled active systemic infection requiring treatment.

          -  Have had treatment for a cancer other than BAC within 5 years prior to enrollment,
             with the exception of basal cell carcinoma or cervical cancer in situ.

          -  Have a history of allergic reaction attributable to compounds containing boron or
             mannitol or hypersensitivity reactions to drugs formulated with polysorbate 80.

          -  Have known human immunodeficiency virus (HIV)-positive or hepatitis B surface
             antigen-positive status or known active hepatitis C infection. Patients assessed by
             the investigator to be at risk for HIV, hepatitis B or C infection should be tested in
             accordance with local regulations.

          -  Have poorly controlled hypertension, diabetes mellitus, or another serious medical or
             psychiatric illness that could, in the investigator's opinion, potentially interfere
             with the completion of treatment according to this protocol.

          -  Are a pregnant or breast-feeding female. Confirmation that the patient is not pregnant
             must be established by a negative serum β-human chorionic gonadotropin (β-hCG)
             pregnancy test result obtained during the screening period. Pregnancy testing is not
             required for post-menopausal or surgically sterilized women.

          -  Are unwilling to employ adequate means of contraception (condoms, diaphragm, birth
             control pills, injections, intrauterine device, or abstinence).

          -  Are currently receiving or have previously received an investigational agent for any
             reason within 4 weeks of enrollment.