Malignant pleural disease of all histological cell types. 50% patients in trial will have indwelling pleural catheters for management of breathlessness.
Conditions
Interventions
Trade Name: Zometa 4mg/5ml Concentrate for Solution for Infusion.
Product Name: Zometa 4mg/5ml concentration for solution for infusion
Pharmaceutical Form: Concentrate and solvent for solution for inj
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1/. Malignant pleural thickening with or without pleural effusion with a. malignant fluid cytology or b. malignant pleural biopsy histology or c. in the context of clinically proven cancer elsewhere with no alternative cause found for the pleural thickening or effusion and 2/. Age > 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1/. Chemical or surgical pleurodesis in the preceding 30 days. 2/. IV bisphosphonate within the past 3 months or ongoing therapy. 3/. Ongoing dental disease requiring intervention. 4/. Significant renal failure (calculated creatinine clearance of <40ml/min) 5/. Hypocalcaemia at randomisation. 6/. Inability to give informed consent. 7/. Pregnancy or lactation. 8/. Known allergy to bisphosphonates or exipients in the intervention preparation. 9/. Life expectancy < 4 months. 10/. Current or planned chemotherapy (However patients receiving the oral chemotherapy agent, tarceva who have been on it for more than 3 months can be included). 11/. Hormone manipulation therapy initiated in the month before trial entry (however patients receiving long term hormone manipulation can be included). 12/. Haematological malignancy. 13/. Age < 18 years (no upper age limit). 14/. Severe visual impairment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine whether zoledronic acid in the form of Zometa reduces pleural fluid production, tumour volume and improves breathlessness and quality of life in patients with a malignant pleural disease when administered in its licenced dose for administration to patients with malignancy.;Secondary Objective: To establish drug concentration in pleural fluid following intravenous administration.;Primary end point(s): 1/. Change in gadolinium uptake and washout rate on DCE-MRI 2/. Change in dyspnoea VAS score. ;Timepoint(s) of evaluation of this end point: Over the 9 week trial period, with long term follow up in the specialist pleural clinic at Southmead Hospital | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1/. Disease progression as measured by volume of pleural thickening on CT scan 2/. Disease progression as measured by volume of pleural thickening on DCE-MRI scan. 3/. For patients with a pleurx catheter in situ, change in fluid volume production between week 2 of run in period and each week post intervention or placebo. 4/. For patients with pleurx catheter in situ, spontaneous pleurodesis rate. 5/. Change in pleural fluid and plasma VEGF-A between baseline and each aspiration following intervention or placebo (with correlation to fluid drainage in pleurx patients). 6/. Change in volume of pleural fluid on CT.;Timepoint(s) of evaluation of this end point: Over the 9 week trial period, with long term follow up in the specialist pleural clinic at Southmead Hospital | — |
Countries
United Kingdom
Outcome results
None listed