Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Bortezomib in Treating Patients With Malignant Pleural Mesothelioma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	18 and over	Other	ICORG-05-10 ICORG-05-10, EUDRACT-2005-004420-39, EU-20748, NCT00513877

Objectives

Primary

1. Assess the clinical efficacy of bortezomib based on the evaluation of objective tumor response rate.

Secondary

1. Assess additional clinical efficacy of bortezomib based on the evaluation of time to early disease progression and median overall 2-year survival rate.
2. Assess safety and toxicity in these patients.
3. Assess quality of life using the Lung Cancer Symptom Score.

Entry 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

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

Patient Characteristics:

Inclusion criteria:

• ECOG performance status 0-2
• Hemoglobin ≥ 10 g/dL
• Neutrophil count ≥ 1,500 mm³
• Platelet count ≥ 100,000/mm³
• 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

Expected Enrollment

57 first-line setting and 54 second-line setting patients will be accrued for this study.

Outcomes

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

Time to disease progression
Overall survival
Safety
Quality of life

Outline

This is a multicenter study. Patients are stratified according to current treatment (first-line vs second-line)

Patients receive bortezomib IV on days 1, 8, 15, and 22. Treatment repeats every 5 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients exhibiting objective response or stable disease by week 20, may continue treatment at the discretion of the investigator until evidence of disease progression.

Quality of life is assessed periodically.

After completion of study treatment, patients are followed for up to 2 years.

Trial Contact Information

Trial Lead Organizations

Irish Clinical Oncology Research Group

Dean Fennell, MD, PhD, Principal investigator		Ph: 44-28-9097-2960 Email: d.fennell@qub.ac.uk

Belgium
	Ghent
	Universitair Ziekenhuis Gent
		Jan Van Meerbeeck, MD, PhD	Ph:  32-9-332-2611
			Email: jan.vanmeerbeeck@ugent.be
Ireland
	Cork
	Cork University Hospital
		Branislav Bystricky	Ph:  353-21-492-0052
			Email: branislav.bystricky@mailp.hse.ie
	Dublin
	Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
		Ray McDermott, MD	Ph:  353-1-414-2012
			Email: ray.mcdermott@amnch.ie
	Beaumont Hospital
		Oscar Breathnach, MD	Ph:  353-1-809-2373
	Mater Misericordiae University Hospital
		Desmond Carney, MD	Ph:  353-1-838-4444
	St. James's Hospital
		Kenneth O'Byrne, MD	Ph:  353-1-410-3545
	St. Vincent's University Hospital
		John Crown, MD	Ph:  011-353-1-269-5033
	Galway
	Galway University Hospital
		Maccon Keane, MD	Ph:  353-91-524-222
			Email: maccon.keane@mailn.hse.ie
Netherlands
	Amsterdam
	Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
		Paul Baas, MD, PhD	Ph:  020-512-2958
			Email: p.baas@nki.nl
United Kingdom
England
	London
	Saint Bartholomew's Hospital
		Jeremy Steele, MD	Ph:  44-207-601-7577
	Sutton
	Royal Marsden - Surrey
		Mary O'Brien, MD	Ph:  44-20-8661-3276
			Email: mary.o'brien@rmh.nhs.uk
Northern Ireland
	Belfast
	Centre for Cancer Research and Cell Biology at Queen's University Belfast
		Dean Fennell, MD, PhD	Ph:  44-28-9097-2960
			Email: d.fennell@qub.ac.uk
Scotland
	Glasgow
	Beatson West of Scotland Cancer Centre
		David Dunlop, MD	Ph:  44-141-211-2837
			Email: dunlopdj@excute.com

Registry Information
Official Title		An Open Label Phase II Multicentre Clinical Trial of Single Agent Bortezomib in Patients with Malignant Pleural Mesothelioma
Trial Start Date		2006-05-01
Registered in ClinicalTrials.gov		NCT00513877
Date Submitted to PDQ		2007-07-17
Information Last Verified		2007-08-03

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