Clinical trial NCT00513877 (phase 2, status: completed)
Conditions: malignant mesothelioma
ICD codes: C45.9, C45.0, C45.1, C45.2, C45.7
Drugs: bortezomib
SMILES: ClCCN(CCCl)P1(=O)NCCCO1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

        Inclusion criteria:

          -  Histologically confirmed malignant pleural mesothelioma

          -  Meets 1 of the following criteria for first-line or second-line chemotherapy:

               -  Patients in the first-line setting must be unsuitable for, cannot access locally,
                  or refuse combination chemotherapy

               -  Patients in the second-line setting must be unsuitable for, cannot access
                  locally, or refuse cytotoxic chemotherapy after failure of a first-line regimen

                    -  Second-line patients may not have received more than 1 prior line of
                       antineoplastic treatment for this cancer

          -  Pleural effusions should be drained before treatment whenever possible

               -  Talc or tetracycline pleurodesis may be used per standard practice for
                  uncontrollable pleural effusions (recurrent despite regular drainage)

        Exclusion criteria:

          -  Symptomatic or known brain or leptomeningeal metastases

        PATIENT CHARACTERISTICS:

        Inclusion criteria:

          -  ECOG performance status 0-2

          -  Hemoglobin ≥ 10 g/dL

          -  Neutrophil count ≥ 1,500 mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Creatinine clearance ≥ 30 mL/min

          -  AST and ALT < 3 times upper limit of normal

          -  Fertile patients must use effective contraception during study therapy

        Exclusion criteria:

          -  Pregnant or breastfeeding

          -  History of prior malignant tumor within the past 3 years except for nonmelanoma skin
             tumor or carcinoma in situ of the cervix

          -  Patients suitably fit to receive a platinum doublet based chemotherapy (first-line
             only)

          -  Uncontrolled or severe cardiovascular disease including any of the following:

               -  Myocardial infarction within the past 6 months

               -  New York Heart Association class III or IV heart failure

               -  Uncontrolled angina

               -  Clinically significant pericardial disease

               -  Cardiac amyloidosis

          -  Neuropathy ≥ grade 2 OR grade 1 with pain

          -  Serious medical (e.g., uncontrolled diabetes, hepatic disease, or infection) or
             psychiatric illness that would interfere with study participation

          -  Patients with known HIV or hepatitis B or C infection

        PRIOR CONCURRENT THERAPY:

          -  No prior bortezomib

          -  No prior extensive radiation therapy, systemic chemotherapy, or other antineoplastic
             therapy within 4 weeks before enrollment

          -  No preplanned surgery or procedures that would interfere with the study

          -  More than 4 weeks since enrollment in another therapeutic clinical trial (i.e.,
             received an experimental drug or used an experimental medical device)

               -  Concurrent participation in non-treatment studies is allowed provided they do not
                  interfere with participation in this study

          -  No concurrent experimental or antineoplastic agent other than bortezomib

               -  Medications that may have antineoplastic activity, but are taken for other
                  reasons than specific antineoplastic effect (e.g., megestrol [Megace®],
                  cyclo-oxygenase-2 [COX-2] inhibitors, or bisphosphonates) are allowed