This study is for patients with malignant mesothelioma of the lung lining (called pleura) who
have had previous chemotherapy with a platinum-based regimen whose disease has progressed.
Malignant pleural mesothelioma (MPM) is an aggressive, frequently drug resistant, and
incurable disease that is increasing in incidence in the UK and worldwide. All patients with
MPM will relapse following first line chemotherapy and at present, there is no standard
treatment available for patients in the second line setting. The vinca alkaloid chemotherapy
drug vinorelbine has shown promising activity in a single arm UK trial. However to date,
there has been no randomised evaluation of vinorelbine in mesothelioma in the second line
setting. In addition, there have been no trials which have looked at underlying molecular
changes in mesothelioma which may predict vinorelbine efficacy; This might allow vinorelbine
to be used in patients only where there is a chance of benefit. Studies suggest that
vinorelbine requires a gene called BRCA1 (shown to be absent in 38% of mesothelioma cases) in
order to induce cell death in mesothelioma. The VIM trial aims to establish whether
vinorelbine in patients with MPM helps them live longer and whether the BRCA1 gene is helpful
in selecting patients most likely to benefit from treatment.
Patients will be randomised (1:2) to receive either active symptom control (ASC) (which is
all supportive care deemed necessary for pain management excluding disease modifying
treatment) or ASC with vinorelbine. Patients will continue vinorelbine treatment until
evidence of disease progression (or unacceptable toxicity to the drug or patient withdrawal).
If vinorelbine activity is demonstrated, we will use the results from this trial to inform
the design of a future phase III trial.
Phase:
Phase 2
Details
Lead Sponsor:
Lisette Nixon Wales Cancer Trials Unit
Collaborators:
Pierre Fabre Laboratories Wales Cancer Trials Unit