Bortezomib in Treating Patients With Malignant Pleural Mesothelioma

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