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This study compares the drug Vinorelbine with active symptom control alone in patients with malignant pleural mesothelioma (a cancer of the lung lining) that progressed after first-line platinum-based chemotherapy. It included patients with confirmed, progressing mesothelioma. It was a Phase 2 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: 1. Confirmed histological diagnosis of malignant pleural mesothelioma. The same block or 10 unstained slides should be available for translational research 2. Prior treatment with first-line standard platinum doublet based chemotherapy only 3. Evidence of disease progression according to CT scan 4. Life expectancy ≥ 3 months 5. ECOG performance status 0-2 6. Men or women aged 18 years or over 7. Willing to consent to provide blood and tissue for translational research 8. Measurable lesions by modified RECIST 9. 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. 10. 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. 11. Patients must provide informed consent prior to any study specific procedures. Exclusion Criteria: 1. 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. 2. Have received treatment with an agent that has not received regulatory approval, within 30 days of study entry. 3. Are pregnant or breastfeeding. 4. Uncontrolled CNS disease. 5. Known contraindication or hypersensitivity to vinorelbine or other vinca alkaloids or to any of the constituents 6. Any disease significantly affecting absorption 7. Previous significant surgical resection of stomach or small bowel 8. Yellow fever vaccine within 30 days of consent 9. Previous vinca alkaloid chemotherapy 10. Palliative radiotherapy within the RECIST area in the 4 weeks prior to baseline CT chest up until randomisation. 11. Patients that are unable to swallow