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NCT Number: NCT01865045

Pharmacogenetics Of Vinorelbine In Malignant Pleural Mesothelioma Patients

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

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Key information

Conditions

Malignant Pleural Mesothelioma Adenoma Lung Diseases Lung Neoplasms Mesothelioma Mesothelioma, Malignant Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • NA

Treatment and study plan

Primary outcomes

  1. Expression of TUBB3 and BRCA1 in MPM tumor tissue by immunohistochemistry and RT-PCR.

    Time frame: 2 months

Secondary outcomes

  1. Association of expression of TUBB3 and BRCA1 with clinical outcome (response, survival) .

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Armando Santoro, MD

Other

Registry information

Official study title

Pharmacogenetics of Vinorelbine in Malignant Pleural Mesothelioma Patient

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
May 30, 2013
Registry last updated
Sep 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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