Malignant mesothelioma MedDRA version: 9.0 Level: LLT Classification code 10027407
Conditions
Interventions
Trade Name: VELCADE
Pharmaceutical Form: Powder for solution for injection
Other descriptive name: BORTEZOMIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3.5-
Sponsors
EORTC-European Organisation for the Research and Treatment of Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Histologically proven pleural malignant mesothelioma ? Recurrent disease after radical surgery or disease not considered suitable for radical treatment ? Measurable or evaluable disease according to modified RECIST ? WHO performance status 0-1 ? Age > 18 years ? Life expectancy > 12 weeks ? Adequate hematological function (ANC count > 1.5 x 109 /L, platelets > 100 x 109/L) ? Creatinine clearance: > 60 ml/min (Cockroft and Gault) or > 50 ml/min (51Cr-EDTA) ? Adequate hepatobiliary function (ALT/AST) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Prior systemic chemotherapy for mesothelioma ? Secondary malignancy except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin ? Prior malignancy treated less than 5 years before without recurrence (BUT: melanoma, breast cancer and hypernephroma treated less than 5 years before and without recurrence are accepted) ? Clinical evidence of brain or leptomeningeal metastases ? Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease or cardiac amyloidosis ? Preexisting peripheral neuropathy ? No known or suspected allergy or intolerance to boron, mannitol or heparin, if an indwelling catheter is used ? Pregnancy or breast feeding ? Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigate the activity and safety of the combination of bortezomib and cisplatin as first line treatment for malignant mesothelioma.;Secondary Objective: - Validate the use of the progression free survival rate (PFSR) as primary end point for the design of mesothelioma phase II trials. - Perform an explorative translational research program, looking at the use of platelet count, Il-6 and pharmacogenomics in the assessment of response rate, PFSR, and survival;Primary end point(s): The primary end-point of the study in this first line treatment group will be progression free survival rate (PFSR) at 18 weeks. | — |
Countries
Belgium, Italy, Slovenia, United Kingdom
Outcome results
None listed