Pharmacogenetics Of Vinorelbine In Malignant Pleural Mesothelioma Patients

Pharmacogenetics of Vinorelbine in Malignant Pleural Mesothelioma Patient

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01865045

Enrollment

150

Registered

2013-05-30

Start date

2012-11-30

Completion date

2017-12-31

Last updated

2022-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Pleural Mesothelioma

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

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Expression of TUBB3 and BRCA1 in MPM tumor tissue by immunohistochemistry and RT-PCR.	2 months

Secondary

Measure	Time frame
Association of expression of TUBB3 and BRCA1 with clinical outcome (response, survival) .	2 months

Countries

Italy

Outcome results