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Pharmacogenetics Of Vinorelbine In Malignant Pleural Mesothelioma Patients

Brief Summary

This is a multicenter retrospective analysis .The aim of the present study is to investigate the molecular predictors of vinorelbine response in tumor samples of a series of MPM patients and evaluate the possible impact on clinical outcome.

Sample size: around 150 patients based on the availability of tumor size

Tracking Information
First Received DateMay 27, 2013
Last Changed DateFebruary 9, 2017
Start DateNovember 2012
Actual Primary Completion DateDecember 2016
Primary Outcome Measures

Expression of TUBB3 and BRCA1 in MPM tumor tissue by immunohistochemistry and RT-PCR. [Time Frame: 2 months]

Secondary Outcome Measures

Association of expression of TUBB3 and BRCA1 with clinical outcome (response, survival) . [Time Frame: 2 months]

Descriptive Information
PhaseN/A
Study TypeObservational
Condition
  • Malignant Pleural Mesothelioma
Study Arms / Comparison Groups0 / 1
Detailed Description

Vinorelbine has recently become an alternative option for palliation in selected pemetrexed-pretreated patients with malignant pleural mesothelioma (MPM). However, nowadays there are no definitive data about vinorelbine predictors of response in MPM patients. The identification of molecular predictors of effective therapy is important for maximizing therapeutic efficacy and minimizing useless treatment in cancer patients.

In oncology a pharmacogenetic approach to customize the chemotherapy treatment according to individual as well as tumour genetic characteristics represents a modern and intriguing challenge. Recent studies have suggested that the expression levels of class III β-tubulin (TUBB3) or BRCA1, are related to a survival benefit from vinorelbine chemotherapy among patients with advanced solid malignancies, especially non-small cell lung cancer. There are no data about the predictive factors to vinorelbine in MPM patients. The identification of molecular predictors of effective therapy may allow in the future the development of better therapies.

Recruitment Information
Recruitment StatusActive, not recruiting
Anticipated Enrollment150
GenderAll
AgesN/A - N/A
Accepts Healthy VolunteersNo
Eligibility Criteria

Inclusion Criteria:

- MPM patients treated with vinorelbine in the ≥ second line setting will be retrospectively analyzed

- Patients will be selected based on the availability of tumor tissue

Exclusion Criteria:

Administrative Information
NCTIDNCT01865045
Responsible Party,
SponsorArmando Santoro, MD
Verification DateFebruary 2017
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