Clinical trial · Interventional
Bortezomib in Treating Patients With Malignant Pleural Mesothelioma
An Open Label Phase II Multicentre Clinical Trial of Single Agent Bortezomib in Patients With Malignant Pleural Mesothelioma
NCT00513877CI-TRIAL-00016488completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Mesothelioma | Malignant Mesothelioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bortezomib 1.6mg/m2
- interventionNames
- Drug: bortezomib
- Procedure: quality-of-life assessment
Primary outcomes (1)
- measure
- Objective tumor response rate (complete response or partial response) as assessed by modified RECIST criteria
- timeFrame
- 28 days prior to baseline, at 10 weeks and at end of treatment
- description
- The objective tumour response rate is a primary endpoint of the study. This will be a proportion of evaluable subjects who achieve a confirmed CR or PR per modified RECIST guidelines within four cycles (20 weeks) of treatment.
Secondary outcomes (4)
- measure
- Time to disease progression
- timeFrame
- Time to disease progression is measured from first treatment until the date of PD or death whichever is first reported. Subjects who did not progress or die will be censored at the day of their last tumour assessment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 allowedReferences
Publications (1)
- DERIVEDWalter RFH, Sydow SR, Berg E, Kollmeier J, Christoph DC, Christoph S, Eberhardt WEE, Mairinger T, Wohlschlaeger J, Schmid KW, Mairinger FD. Bortezomib sensitivity is tissue dependent and high expression of the 20S proteasome precludes good response in malignant pleural mesothelioma. Cancer Manag Res. 2019 Sep 24;11:8711-8720. doi: 10.2147/CMAR.S194337. eCollection 2019. PMID 31576173