Bortezomib in Treating Patients With Malignant Pleural Mesothelioma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying the side effects of bortezomib and how well it works in treating patients with malignant pleural mesothelioma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cancer Trials Ireland
• Treatments: Bortezomib

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