From the blog

Vinorelbine in Mesothelioma (VIM)

Published: June 11, 2014


Primary Outcome Measures:

  • Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Anti-tumour activity of vinorelbine will be measured by overall survival, time from randomisation to death.

Secondary Outcome Measures:

  • Progression Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Anti-tumour activity of vinorelbine will also be measured by progression free survival. We will document time from randomisation to any disease progression and/or death, defined according to strict RECIST v1.1. Lesions will be compared with baseline measurements to assess progression
  • Number of serious adverse events reported [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    The toxicity profile of oral vinorelbine in this setting will be used to assess safety. An independent data monitoring committee will convene and assess safety 6 months after the first patient has been randomised. If the trial is deemed safe to continue then safety will be assessed again approx every 6 months. Toxicity data will be assessed alongside serious adverse events.
  • BRCA1 status in blood and tumour samples [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Tumour and blood samples will be collected for future translational research. BRCA1 expression as a putative predictor of vinorelbine sensitivity will be measured primarily in the samples.

Eligibility Criteria

Inclusion Criteria:
  • Confirmed histological diagnosis of malignant pleural mesothelioma. The same block or 10 unstained slides should be available for translational research
  • Prior treatment with first-line standard platinum doublet based chemotherapy only
  • Evidence of disease progression according to CT scan
  • Life expectancy ≥ 3 months
  • ECOG performance status 0-2
  • Men or women aged 18 years or over
  • Willing to consent to provide blood and tissue for translational research
  • Measurable lesions by modified RECIST
  • Adequate organ function, including the following: Adequate bone marrow reserve: absolute neutrophil count (ANC) ≥ 1.5 x 109/L, WBC >3 x 109/L, haemoglobin ≥ 100g/L, platelets ≥ 100 x 109/L; adequate liver function: Bilirubin <1.5 x ULN AST/ALT 1.5- 2.5 x ULN.
  • Patients with reproductive potential (male or female), who are sexually active during the duration of the trial or the drug washout period, should be prepared to use two effective forms of contraception throughout their participation in the trial and for at least three months after the last dose of vinorelbine.
  • Patients must provide informed consent prior to any study specific procedures.
Exclusion Criteria:
  • Patients with a diagnosis of a second malignancy except prostate or cervical cancer in remission or patients with a diagnosis of basal cell carcinoma of the skin.
  • Have received treatment with an agent that has not received regulatory approval, within 30 days of study entry.
  • Are pregnant or breastfeeding.
  • Uncontrolled CNS disease.
  • Known contraindication or hypersensitivity to vinorelbine or other vinca alkaloids or to any of the constituents
  • Any disease significantly affecting absorption
  • Previous significant surgical resection of stomach or small bowel
  • Yellow fever vaccine within 30 days of consent
  • Previous vinca alkaloid chemotherapy
  • Palliative radiotherapy within the RECIST area in the 4 weeks prior to baseline CT chest up until randomisation.
  • Patients that are unable to swallow
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