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

NCT ID: NCT00867711

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

121 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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MALIGNANT PLEURAL MESOTHELIOMA

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* MPM diagnosis
* Availability of tumor tissue to perform analysis

Exclusion Criteria

* Other primary diagnosis
* No archival tissue available
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Clinico Humanitas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Armando Santoro, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Clinico Humanitas

Locations

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Istituto Clinico Humanitas

Rozzano, Milano, Italy

Site Status

Countries

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Italy

References

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Zucali PA, Giovannetti E, Destro A, Mencoboni M, Ceresoli GL, Gianoncelli L, Lorenzi E, De Vincenzo F, Simonelli M, Perrino M, Bruzzone A, Thunnissen E, Tunesi G, Giordano L, Roncalli M, Peters GJ, Santoro A. Thymidylate synthase and excision repair cross-complementing group-1 as predictors of responsiveness in mesothelioma patients treated with pemetrexed/carboplatin. Clin Cancer Res. 2011 Apr 15;17(8):2581-90. doi: 10.1158/1078-0432.CCR-10-2873. Epub 2011 Jan 24.

Reference Type DERIVED
PMID: 21262916 (View on PubMed)

Other Identifiers

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ONC/OSS-04/2008

Identifier Type: -

Identifier Source: org_study_id