Bortezomib in Treating Patients With Malignant Pleural Mesothelioma

NCT00513877 | Completed Phase 2

• 4 other identifiers: 05-10 ICORGICORG-05-10EUDRACT-2005-004420-39EU-20748
• Study Type: interventional
• Target: 33
• Locations: 4 countries
• Sites: 13

Brief 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.

Conditions

Malignant Mesothelioma

Keywords

recurrent malignant mesothelioma; stage IA malignant mesothelioma; stage IB malignant mesothelioma; stage II malignant mesothelioma; stage III malignant mesothelioma; stage IV malignant mesothelioma

Outcome Measures

Primary Outcomes (1)

• Objective tumor response rate (complete response or partial response) as assessed by modified RECIST criteria

  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.

  28 days prior to baseline, at 10 weeks and at end of treatment

Secondary Outcomes (4)

• Time to disease progression

  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.

• Overall survival

  Overall Survival is measured from the date of first treatment to the date of the subject's death. If the subject is alive or the vital status is unknown, the date of death will be censored at the date that the subject is last known to be alive.

• Safety

  The assessment of safety will be based mainly on the frequency of adverse events and on the number of laboratory values that fall outside of the pre-determined normal ranges.

• Quality of life

  Week 1, Week 10 and end of treatment

Study Arms (1)

Bortezomib 1.6mg/m2

EXPERIMENTAL

Drug: bortezomib; Procedure: quality-of-life assessment

Interventions

bortezomib DRUG

Bortezomib 1.6mg/m2

quality-of-life assessment PROCEDURE

Bortezomib 1.6mg/m2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Symptomatic or known brain or leptomeningeal metastases
• PATIENT CHARACTERISTICS:
• 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
• 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

Sponsors & Collaborators

• Cancer Trials Ireland: lead

Study Sites (13)

Universitair Ziekenhuis Gent

Ghent, B-9000, Belgium

Location

Cork University Hospital

Cork, Ireland

Location

Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital

Dublin, 24, Ireland

Location

St. Vincent's University Hospital

Dublin, 4, Ireland

Location

Mater Misericordiae University Hospital

Dublin, 7, Ireland

Location

St. James's Hospital

Dublin, 8, Ireland

Location

Beaumont Hospital

Dublin, 9, Ireland

Location

Galway University Hospital

Galway, Ireland

Location

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, 1066 BE, Netherlands

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Centre for Cancer Research and Cell Biology at Queen's University Belfast

Belfast, Northern Ireland, BT9 7BL, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Related Publications (1)

• Walter 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 DERIVED

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dean A. Fennell, MD, PhD

  Centre for Cancer Research and Cell Biology at Queen's University Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2007
• First Posted: August 9, 2007
• Study Start: May 1, 2006
• Primary Completion: December 1, 2009
• Last Updated: December 31, 2014

Record last verified: 2013-01

Locations

NL (1); BE (1); IE (7); GB (4)