Brief Title
Molecular Predictors of Pemetrexed and Carboplatin Response in Malignant Pleural Mesothelioma (MPM) Patients
Official Title
Pharmacogenetics of Pemetrexed and Carboplatin in Malignant Pleural Mesothelioma Patients
Brief 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.
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
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
Secondary Outcome
Evaluate retrospectively the correlation between gene expression and polymorphisms in candidate genes and array-CGH data, immunohistochemistry data, and clinical data.
Condition
MALIGNANT PLEURAL MESOTHELIOMA
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
121
Start Date
January 2009
Completion Date
December 2011
Primary Completion Date
December 2011
Eligibility Criteria
Inclusion Criteria:
- MPM diagnosis
- Availability of tumor tissue to perform analysis
Exclusion Criteria :
- Other primary diagnosis
- No archival tissue available
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Armando Santoro, MD, ,
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT00867711
Organization ID
ONC/OSS-04/2008
Responsible Party
Sponsor
Study Sponsor
Istituto Clinico Humanitas
Study Sponsor
Armando Santoro, MD, Principal Investigator, Istituto Clinico Humanitas
Verification Date
November 2014