Specialty: Cancer, Primary sub-specialty: Lung Cancer
Conditions
Interventions
Participants will be randomised (1:2) to receive either active symptom control (ASC) or ASC with vinorelbine. Participant randomisation will be performed centrally by the WCTU.
Group
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
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. Re-challenge with first line chemotherapy is allowed. 3. Evidence of disease progression according to CT scan on Modified RECIST 4. Life expectancy = 3 months 5. ECOG performance status 0-1 6. Men or women aged 18 years or over 7. Willing to consent to provide blood and tissue for translational research 8. Disease which is measurable using 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. Effective forms of contraception would include condom with spermicide, along with one of the following: oral contraceptive or hormonal therapy (e.g. hormone implants); placement of an inter-uterine device; vasectomy with assurance of post- vasectomy confirmation of azoospermia; tubal occlusion. Accepted hormonal methods include: Etonogestrel implants; normal and low dose combined oral pills; orelgestromin/ethinyl estradiol transdermal system; or desogestrel. 11. Patients must provide informed consent before any study specific procedures
Exclusion criteria
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 no marketing authorisation, within 30 days of study entry 3. Are pregnant or breastfeeding. If a participant becomes pregnant during the trial, and is randomised to the treatment arm, vinorelbine must be discontinued and the participant followed up until birth or termination of pregnancy. Breastfeeding must be avoided as it is unknown whether vinorelbine is excreted in human milk. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival will be measured as time from randomisation to death (from any cause). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Progression free survival is assessed by modified RECIST using baseline CT scan results compared against further CT scans on Day 1 of each cycle of treatment 2. Safety and tolerability and feasibility of use will be assessed during and after treatment by collection of toxicities according to NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 at every clinic visit and reporting of SAEs in real-time 3. Objective response rate as assessed by modified RECIST using baseline CT scan results compared against further CT scans on Day 1 of each cycle of treatment | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactGeorgina Gardner
Outcome results
None listed