- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00867711
Molecular Predictors of Pemetrexed and Carboplatin Response in Malignant Pleural Mesothelioma (MPM) Patients
December 1, 2014 updated by: Istituto Clinico Humanitas
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
121
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Milano
-
Rozzano, Milano, Italy, 20089
- Istituto Clinico Humanitas
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Malignant Pleural Mesothelioma patients treated with carboplatin and pemetrexed
Description
Inclusion Criteria:
- MPM diagnosis
- Availability of tumor tissue to perform analysis
Exclusion Criteria :
- Other primary diagnosis
- No archival tissue available
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
March 23, 2009
First Submitted That Met QC Criteria
March 23, 2009
First Posted (Estimate)
March 24, 2009
Study Record Updates
Last Update Posted (Estimate)
December 2, 2014
Last Update Submitted That Met QC Criteria
December 1, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ONC/OSS-04/2008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on MALIGNANT PLEURAL MESOTHELIOMA
-
NRG OncologyNational Cancer Institute (NCI)TerminatedPleural Biphasic Mesothelioma | Pleural Epithelioid Mesothelioma | Stage I Pleural Malignant Mesothelioma AJCC v8 | Stage IA Pleural Malignant Mesothelioma AJCC v8 | Stage IB Pleural Malignant Mesothelioma AJCC v8 | Stage II Pleural Malignant Mesothelioma AJCC v8 | Stage IIIA Pleural Malignant...United States, Canada
-
University of ChicagoNational Cancer Institute (NCI)Active, not recruitingBiphasic Mesothelioma | Epithelioid Mesothelioma | Peritoneal Malignant Mesothelioma | Pleural Biphasic Mesothelioma | Pleural Epithelioid Mesothelioma | Pleural Malignant Mesothelioma | Pleural Sarcomatoid Mesothelioma | Recurrent Peritoneal Malignant Mesothelioma | Recurrent Pleural Malignant Mesothelioma and other conditionsUnited States
-
National Cancer Institute (NCI)Active, not recruitingBiphasic Mesothelioma | Epithelioid Mesothelioma | Stage III Pleural Malignant Mesothelioma AJCC v7 | Stage I Pleural Malignant Mesothelioma AJCC v7 | Stage IA Pleural Malignant Mesothelioma AJCC v7 | Stage IB Pleural Malignant Mesothelioma AJCC v7 | Stage II Pleural Malignant Mesothelioma AJCC...United States
-
RS Oncology LLCRecruitingMesothelioma | Malignant Pleural Mesothelioma | Pleural Effusion, Malignant | Mesotheliomas Pleural | Malignant Pleural Effusion | Mesothelioma; LungUnited Kingdom
-
Health Pharma Professional ResearchWithdrawnMalignant Pleural Mesothelioma, Advanced | Malignant Pleural Mesothelioma, UnresectableMexico
-
National Cancer Institute (NCI)TerminatedEpithelioid Mesothelioma | Sarcomatoid Mesothelioma | Stage IV Pleural Mesothelioma | Recurrent Malignant Mesothelioma | Stage II Pleural Mesothelioma | Stage III Pleural MesotheliomaUnited States
-
National Cancer Institute (NCI)WithdrawnMalignant Pleural Mesotheliomas (Mpm) | Malignant Pleural Effusions (Mpe) | Epithelial Tumors, Malignant | Pleural Effusions, Malignant | Mesothelin (Msln)United States
-
Abramson Cancer Center at Penn MedicineRecruitingEpitheliod Malignant Pleural MesotheliomaUnited States
-
Swiss Group for Clinical Cancer ResearchCompletedMalignant Pleural Mesothelioma, AdvancedSwitzerland, Italy
-
National Cancer Institute (NCI)Active, not recruitingAdvanced Malignant Solid Neoplasm | Refractory Malignant Solid Neoplasm | Recurrent Peritoneal Malignant Mesothelioma | Recurrent Pleural Malignant Mesothelioma | Unresectable Solid Neoplasm | Advanced Pleural Malignant Mesothelioma | Advanced Peritoneal Malignant MesotheliomaUnited States