Contact information
Type
Public
Primary contact
Mrs Georgina Gardner
ORCID ID
Contact details
Wales Cancer Trials Unit
Centre for Trials Research
Cardiff University
6th Floor
Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
+44 29 2068 7950
VIM@Cardiff.ac.uk
Additional identifiers
EudraCT number
2014-001992-30
ClinicalTrials.gov number
Protocol/serial number
32185
Study information
Scientific title
A randomised controlled phase II trial of oral vinorelbine as second line therapy for patients with malignant pleural mesothelioma
Acronym
VIM
Study hypothesis
The aim of this study it to establish whether treatment with vinorelbine in patients with malignant pleural mesothelioma (MPM) actually makes them live longer.
Ethics approval
Wales REC 3, 22/10/2014, ref: 14/WA/1054
Study design
Randomised; Interventional; Design type: Treatment, Drug
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
See additional files
Condition
Specialty: Cancer, Primary sub-specialty: Lung Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasms of respiratory and intrathoracic organs
Intervention
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 A: Participants receive active supportive care only for the duration of the study. Active supportive care is defined as the treatments and procedures used locally to control the symptoms of mesothelioma. Examples of symptoms and possible treatments are listed below, but this list is not exhaustive and any supportive treatment may be classed as ASC.
Breathlessness: Chest drain, relaxation, posture advice, medication, anti-anxiety medication, oxygen
Pain Painkillers, relaxation, massage, referral to specialist pain clinics
Night sweats: Management advice, medication
Loss of appetite: High protein powders/high calorie drinks, steroids, nutritional advice, supplements
Tiredness: Sleep advice, gentle exercise
Anaemia: Blood transfusion
Depression: Counselling, anti-depressants
Other: Acupuncture, massage, aromatherapy and relaxation technique
Group B: Patients will be treated with ASC as above, plus vinorelbine. Vinorelbine (Navelbine) should be administered at a dose of 60mg/m2 orally weekly for the first cycle (days 1, 8 and 15) on a 3-weekly cycle. Subsequent doses should be increased to 80mg/m2 (day 22) if there has been no haematological toxicity. Patients remain on ASC or treatment until disease progression (or unacceptable toxicity or patient withdrawal).
There will be a follow-up assessment at disease progression/End of treatment (Arm B only) and follow-up assessment 30 days after disease progression/End of treatment (Arm B only). Trial follow-up will continue for 18 months after the last participant is randomised.
Intervention type
Other
Phase
Phase II
Drug names
Primary outcome measure
Overall survival will be measured as time from randomisation to death (from any cause).
Secondary outcome measures
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
Overall trial start date
11/09/2013
Overall trial end date
01/09/2019
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 200; UK Sample Size: 200
Participant 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
Recruitment start date
01/03/2016
Recruitment end date
31/10/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Trial participating centre
Velindre NHS Trust
Velindre Road
Whitchurch
Cardiff
CF14 2TL
United Kingdom
Trial participating centre
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
United Kingdom
Trial participating centre
Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB25 2ZN
United Kingdom
Sponsor information
Organisation
University of Leicester
Sponsor details
Research Governance Office
Fielding Johnson Building
Leicester
LE1 7RH
United Kingdom
+44 116 373 6410/223 1660
uolsponsor@leicester.ac.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
30/09/2020
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN44518069_PIS_15Oct14_V3.pdf Uploaded 23/010/2017