MALIGNANT PLEURAL MESOTHELIOMANCT00867711
Molecular Predictors of Pemetrexed and Carboplatin Response in Malignant Pleural Mesothelioma (MPM) Patients
An observational study of MALIGNANT PLEURAL MESOTHELIOMA, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
The aim of the present study is to investigate the molecular predictors of pemetrexed and carboplatin response in tumor samples of a series of MPM patients extracting the DNA and genotyping for the TSER polymorphism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MALIGNANT PLEURAL MESOTHELIOMA
- How many people
- 121 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2009to Dec 2011
- Phase
- Observational
- 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
Study population: Malignant Pleural Mesothelioma patients treated with carboplatin and pemetrexed
Who may be able to join
- MPM diagnosis
- Availability of tumor tissue to perform analysis
Who cannot join
- Other primary diagnosis
- No archival tissue available
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacogenetics of Pemetrexed and Carboplatin in Malignant Pleural Mesothelioma Patients
The aim of the present study is to investigate the molecular predictors of pemetrexed and carboplatin response in tumor samples of a series of MPM patients extracting the DNA and genotyping for the TSER polymorphism.
Read the detailed description
Malignant pleural mesothelioma (MPM) is an aggressive tumor that usually has a poor prognosis. The combination of cisplatin and pemetrexed has recently become the standard of care in the first-line treatment of MPM. For patients who are unfit to receive a cisplatin-based chemotherapy, pemetrexed alone [7] or combined with carboplatin [8] has been proposed as an alternative treatment choice. The identification of molecular predictors of effective therapy is important for maximizing therapeutic efficacy and minimizing useless treatment in cancer patients.
- Conditions
- MALIGNANT PLEURAL MESOTHELIOMA
- Medical subject headings
- Mesothelioma, Malignant
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the expression and allelic variants of a panel of candidate genes involved in the resistance to drugs, the genome wide copy number changes in patients treated with drugs combination in the first line
Measured: one year
Secondary outcomes (1)
Evaluate retrospectively the correlation between gene expression and polymorphisms in candidate genes and array-CGH data, immunohistochemistry data, and clinical data.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2011
- Study completionDec 2011
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 PLEURAL MESOTHELIOMAStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Armando Santoro, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867711
- Sponsor's protocol ID
- ONC/OSS-04/2008
- Status last verified
- Nov 2014
- First submitted
- 23 Mar 2009
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Zucali PA, Giovannetti E, Destro A, Mencoboni M, Ceresoli GL, Gianoncelli L, Lorenzi E, De Vincenzo F, Simonelli M, Perrino M, Bruzzone A, Thunnissen E, Tunesi G, Giordano L, Roncalli M, Peters GJ, Santoro A. Thymidylate synthase and excision repair cross-complementing group-1 as predictors of responsiveness in mesothelioma patients treated with pemetrexed/carboplatin. Clin Cancer Res. 2011 Apr 15;17(8):2581-90. doi: 10.1158/1078-0432.CCR-10-2873. Epub 2011 Jan 24.
PubMed 21262916
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetics of Pemetrexed and Carboplatin in Malignant Pleural Mesothelioma Patients
- ClinicalTrials.gov ID
- NCT00867711
- Acronym / sponsor ID
- ONC/OSS-04/2008
- Conditions
- MALIGNANT PLEURAL MESOTHELIOMA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 24 Mar 2009 (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.
The aim of the present study is to investigate the molecular predictors of pemetrexed and carboplatin response in tumor samples of a series of MPM patients extracting the DNA and genotyping for the TSER polymorphism.
Detailed description
Malignant pleural mesothelioma (MPM) is an aggressive tumor that usually has a poor prognosis. The combination of cisplatin and pemetrexed has recently become the standard of care in the first-line treatment of MPM. For patients who are unfit to receive a cisplatin-based chemotherapy, pemetrexed alone [7] or combined with carboplatin [8] has been proposed as an alternative treatment choice. The identification of molecular predictors of effective therapy is important for maximizing therapeutic efficacy and minimizing useless treatment in cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Malignant Pleural Mesothelioma patients treated with carboplatin and pemetrexed
Key inclusion criteria (2 listed)
- MPM diagnosis
- Availability of tumor tissue to perform analysis
Key exclusion criteria (2 listed)
- Other primary diagnosis
- No archival tissue available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the expression and allelic variants of a panel of candidate genes involved in the resistance to drugs, the genome wide copy number changes in patients treated with drugs combination in the first line
Time frame: one year
1 secondary outcome
Evaluate retrospectively the correlation between gene expression and polymorphisms in candidate genes and array-CGH data, immunohistochemistry data, and clinical data.
Time frame: one year
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 2 Dec 2014.
- Derived from this study: PubMed 21262916Zucali PA, Giovannetti E, Destro A, Mencoboni M, Ceresoli GL, Gianoncelli L, Lorenzi E, De Vincenzo F, Simonelli M, Perrino M, Bruzzone A, Thunnissen E, Tunesi G, Giordano L, Roncalli M, Peters GJ, Santoro A. Thymidylate synthase and excision repair cross-complementing group-1 as predictors of responsiveness in mesothelioma patients treated with pemetrexed/carboplatin. Clin Cancer Res. 2011 Apr 15;17(8):2581-90. doi: 10.1158/1078-0432.CCR-10-2873. Epub 2011 Jan 24.
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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.
Armando Santoro, MD principal investigator
Istituto Clinico Humanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MALIGNANT PLEURAL MESOTHELIOMA, run by Istituto Clinico Humanitas at 1 site in Italy.
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 2 inclusion and 2 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 2 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 1 site in Italy. 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.
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?
Evaluate the expression and allelic variants of a panel of candidate genes involved in the resistance to drugs, the genome wide copy number changes in patients treated with drugs combination in the first line (time frame: one year). 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 NCT00867711, 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 2 Dec 2014.