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Molecular Predictors of Pemetrexed and Carboplatin Response in Malignant Pleural Mesothelioma (MPM) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00867711
Recruitment Status : Completed
First Posted : March 24, 2009
Last Update Posted : December 2, 2014
Information provided by (Responsible Party):
Istituto Clinico Humanitas

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.

Condition or disease

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.

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Study Type : Observational
Actual Enrollment : 121 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Pharmacogenetics of Pemetrexed and Carboplatin in Malignant Pleural Mesothelioma Patients
Study Start Date : January 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Malignant Pleural Mesothelioma patients treated with carboplatin and pemetrexed

Inclusion Criteria:

  • MPM diagnosis
  • Availability of tumor tissue to perform analysis

Exclusion Criteria :

  • Other primary diagnosis
  • No archival tissue available

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00867711

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Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20089
Sponsors and Collaborators
Istituto Clinico Humanitas
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Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Istituto Clinico Humanitas Identifier: NCT00867711    
Other Study ID Numbers: ONC/OSS-04/2008
First Posted: March 24, 2009    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Mesothelioma, Malignant
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Pleural Neoplasms
Lung Diseases
Respiratory Tract Diseases