Molecular Predictors of Pemetrexed and Carboplatin Response in Tumor Samples of a Series of Malignant Pleural Mesothelioma (MPM) Patients and Genotyping for the TSER Polymorphism
Recruitment status was Active, not recruiting
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.
Malignant Pleural Mesothelioma
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Pharmacogenetics of Pemetrexed and Carboplatin in Malignant Pleural Mesothelioma Patients|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
The paraffin-embedded tumor specimens of patients will be collected. The tumor RNA and DNA will be extracted and genotyping, gene expression and gene copy number analyses will be performed with validated PCR and array-CGH techniques.
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||September 2009|
|Estimated Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
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  or combined with carboplatin  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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00867711
|Istituto Clinico Humanitas|
|Rozzano, Milano, Italy, 20089|
|Principal Investigator:||Armando Santoro, MD||Istituto Clinico Humanitas|