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

MALIGNANT PLEURAL MESOTHELIOMA Clinical Trial

Official title:

Pharmacogenetics of Pemetrexed and Carboplatin in Malignant Pleural Mesothelioma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00867711
• Other study ID #: ONC/OSS-04/2008
• Status: Completed
• Phase: N/A
• First received: March 23, 2009
• Last updated: December 1, 2014
• Start date: January 2009
• Est. completion date: December 2011

Study information

• Verified date: November 2014
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• MPM diagnosis

• Availability of tumor tissue to perform analysis

Exclusion Criteria :

• Other primary diagnosis

• No archival tissue available

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• MALIGNANT PLEURAL MESOTHELIOMA
• Mesothelioma

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		one year	No
Secondary	Evaluate retrospectively the correlation between gene expression and polymorphisms in candidate genes and array-CGH data, immunohistochemistry data, and clinical data.		one year	No