Malignant pleural mesothelioma MedDRA version: 19.0 Level: PT Classification code 10027406 Term: Mesothelioma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.0 Level: PT Classification code 10035603 Term: Pleural mesothelioma System Organ Class: 10029104 - Neoplasms
Conditions
Interventions
Trade Name: Zometa 4 mg/5 ml concentrate for solution for infusion
Product Name: Zoledronic acid
Pharmaceutical Form: Concentrate for solution for injection
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Histo-cytologically confirmed diagnosis of MPM -WHO performance status 0-1 -Eligible for first line chemotherapy treatment -Measurable disease on CT as per modified RECIST criteria (tumour thickness >5mm) -Ability to give informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45
Exclusion criteria
Exclusion criteria: Not fit for chemotherapy due to performance status or other comorbidities Previous chemotherapy for MPM IV bisphosphonates in the 3 months preceding randomisation Significant renal disease (eGFR < 30ml/min in the last 4 weeks) Hypocalcaemia (current hypocalcaemia on treatment, evidence of hypocalcaemia on most recent blood tests – should be within the last 6 weeks) Known allergy to bisphosphonates or excipients of its preparation Severe untreated dental caries Concomitant participation in another drug trial for mesothelioma Allergy to 18-Fluodeoxyglucose used for the PET scan Women of child bearing potential (defined as fertile, or following menarche and until becoming post-menopausal unless permanently sterile)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Following completion of 6 months of follow-up for all recruited patients ; Main Objective: As this is a feasibility study there are no primary or secondary objectives to the trial. The overarching question is whether it would be feasible to run a full trial to determine if the addition of Zoledronic acid to 1st line chemotherapy would confer a further benefit to patients with mesothelioma, with regards to survival. The feasibility of this trial will be assessed along the following criteria: 1. Feasibility of randomising 50 patients in 12 months 2. Acceptability of recruitment procedures, consent and randomisation, and data collection methods. 3. Acceptability of ZA in MPM patients, and the optimal timing and location for ZA administration. 4. Qualitative assessment in a subgroup of 10 patients (from the randomised and non-randomised groups) to evaluate patients' experience in the randomisation and/or recruitment process 5. Quantification of drop-out and data completeness rates 6. Estimates of outcome event rates eg. survival times, measures of mean response and outco ; Secondary Objective: If this trial proves that it is feasible to run an appropriately statistically powered trial, the outcomes we would be looking for are as below: • Proportion of patients with progression free survival at 6 months • Time to progression • Overall survival from randomisation • Progression free survival from randomisation • Rate of progression of MPM, as measured by modified RECIST criteria on CT, after 3 cycles of chemotherapy (Pemetrexed/Cisplatin) • Rate of progression in MPM, as measured by modified RECIST criteria on CT, after 6 cycles of chemotherapy. • Tumour metabolic | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Acceptability of recruitment procedures, consent and randomisation, and data collection methods. -Acceptability of ZA in MPM patients, and the optimal timing and location for ZA administration. -Qualitative assessment in a subgroup of 10 patients to evaluate patients experience in the randomisation and recruitment process -Quantification of drop-out and data completeness rates -Estimates of outcome event rates eg. survival times, measures of mean response and outcome variance (continuous variables such as quality of life) and confidence intervals around estimates of proportions, categorical variables such as recruitment rates)to use for calculation of full trial size and number of recruitment centres | — |
Countries
United Kingdom
Contacts
Public ContactDuneesha de Fonseka
North Bristol NHS Trust
Outcome results
None listed