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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00867711
First Posted: March 24, 2009
Last Update Posted: December 2, 2014
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.
Information provided by (Responsible Party):
Istituto Clinico Humanitas
  Purpose
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
MALIGNANT PLEURAL MESOTHELIOMA

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Pharmacogenetics of Pemetrexed and Carboplatin in Malignant Pleural Mesothelioma Patients

Resource links provided by NLM:


Further study details as provided by Istituto Clinico Humanitas:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 121
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Criteria

Inclusion Criteria:

  • MPM diagnosis
  • Availability of tumor tissue to perform analysis

Exclusion Criteria :

  • Other primary diagnosis
  • No archival tissue available
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00867711


Locations
Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20089
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT00867711     History of Changes
Other Study ID Numbers: ONC/OSS-04/2008
First Submitted: March 23, 2009
First Posted: March 24, 2009
Last Update Posted: December 2, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Carboplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors