Malignant MesotheliomaPhase 2NCT00513877
Bortezomib in Treating Patients With Malignant Pleural Mesothelioma
A Phase 2 study testing bortezomib and quality-of-life assessment in people with Malignant Mesothelioma, run by Cancer Trials Ireland at 13 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Mesothelioma
- What is being tested?
- bortezomib and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 13 sitesin 4 countries
- Study dates
- May 2006to Dec 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Talc or tetracycline pleurodesis may be used per standard practice for uncontrollable pleural effusions (recurrent despite regular drainage)
- 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
Who cannot join
- Symptomatic or known brain or leptomeningeal metastases
- PATIENT CHARACTERISTICS:
- 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:
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- 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
Trial locations and contacts
13 sites in 4 countries.
13 sites in 4 countries
Ireland7 sites
Cork University Hospital
Cork
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
Dublin, 24
St. Vincent's University Hospital
Dublin, 4
Mater Misericordiae University Hospital
Dublin, 7
St. James's Hospital
Dublin, 8
Beaumont Hospital
Dublin, 9
Galway University Hospital
Galway
United Kingdom4 sites
Centre for Cancer Research and Cell Biology at Queen's University Belfast
Belfast, Northern Ireland, BT9 7BL
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, G11 6NT
Saint Bartholomew's Hospital
London, England, EC1A 7BE
Royal Marsden - Surrey
Sutton, England, SM2 5PT
Netherlands1 site
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, 1066 BE
About this study
Official title: An Open Label Phase II Multicentre Clinical Trial of Single Agent Bortezomib in Patients With Malignant Pleural Mesothelioma
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.
Read the detailed description
OBJECTIVES:
Primary
- Assess the clinical efficacy of bortezomib based on the evaluation of objective tumor response rate.
Secondary
- Assess additional clinical efficacy of bortezomib based on the evaluation of time to early disease progression and median overall 2-year survival rate.
- Assess safety and toxicity in these patients.
- Assess quality of life using the Lung Cancer Symptom Score.
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.
PROJECTED ACCRUAL: 57 first-line setting and 54 second-line setting patients will be accrued for this study.
- Conditions
- Malignant Mesothelioma
- Being tested
- bortezomib, quality-of-life assessment
- Keywords
- recurrent malignant mesothelioma, stage IA malignant mesothelioma, stage IB malignant mesothelioma, stage II malignant mesothelioma, stage III malignant mesothelioma, stage IV malignant mesothelioma
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bortezomibDrug
quality-of-life assessmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Bortezomib 1.6mg/m2 | Experimental | Not described Receives: Drug: bortezomib; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days prior to baseline, at 10 weeks and at end of treatment
Secondary outcomes (4)
Time to disease progression
Measured: 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
Measured: 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
Measured: 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
Quality of life will be assessed using the Lung Cancer Symptom Score
Measured: Week 1, Week 10 and end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2007 (estimated)
- Study startMay 2006
- Primary completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant MesotheliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Dean A. Fennell, MD, PhD, Principal investigator, Centre for Cancer Research and Cell Biology at Queen's University Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00513877
- Sponsor's protocol ID
- 05-10 ICORG
- Other IDs
- ICORG-05-10, EUDRACT-2005-004420-39, EU-20748
- Status last verified
- Jan 2013
- First submitted
- 8 Aug 2007
- Last updated
- 31 Dec 2014
- Results posted
- No
Publications
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.
PubMed 31576173
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase II Multicentre Clinical Trial of Single Agent Bortezomib in Patients With Malignant Pleural Mesothelioma
- ClinicalTrials.gov ID
- NCT00513877
- Acronym / sponsor ID
- 05-10 ICORG
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- May 2006
- Primary completion
- Dec 2009 (actual)
- First posted
- 9 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
Primary
- Assess the clinical efficacy of bortezomib based on the evaluation of objective tumor response rate.
Secondary
- Assess additional clinical efficacy of bortezomib based on the evaluation of time to early disease progression and median overall 2-year survival rate.
- Assess safety and toxicity in these patients.
- Assess quality of life using the Lung Cancer Symptom Score.
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.
PROJECTED ACCRUAL: 57 first-line setting and 54 second-line setting patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bortezomib 1.6mg/m2 | Experimental | Drug: bortezomib, Procedure: quality-of-life assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically confirmed malignant pleural mesothelioma
- Meets 1 of the following criteria for first-line or second-line chemotherapy:
- Pleural effusions should be drained before treatment whenever possible
- ECOG performance status 0-2
- Hemoglobin ≥ 10 g/dL
Key exclusion criteria (22 listed)
- Symptomatic or known brain or leptomeningeal metastases
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bortezomib | Drug | Bortezomib 1.6mg/m2 |
| quality-of-life assessment | Procedure or surgery | Bortezomib 1.6mg/m2 |
Primary outcome
Objective tumor response rate (complete response or partial response) as assessed by modified RECIST criteria
Time frame: 28 days prior to baseline, at 10 weeks and at end of treatment
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.
4 secondary outcomes
Time to disease progression
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Week 1, Week 10 and end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
- Derived from this study: PubMed 31576173Walter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dean A. Fennell, MD, PhD principal investigator
Centre for Cancer Research and Cell Biology at Queen's University Belfast
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bortezomib and quality-of-life assessment in people with Malignant Mesothelioma, run by Cancer Trials Ireland at 13 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Ireland, United Kingdom, Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective tumor response rate (complete response or partial response) as assessed by modified RECIST criteria (time frame: 28 days prior to baseline, at 10 weeks and at end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00513877, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2014.