Phase II study of Bortezomib (VELCADE) with cisplatin as first line treatment of malignant mesothelioma

Phase 1

Conditions: Malignant mesothelioma
MedDRA version: 9.0 Level: LLT Classification code 10027407

Registration Number: EUCTR2006-000009-51-GB

Lead Sponsor: EORTC-European Organisation for the Research and Treatment of Cancer

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 0

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) < 2.5 x upper limit of normal range (ULN) or < 5 x ULN for subjects with liver metastases, bilirubin < 1.5 x ULN)
?Urine pregnancy test mandatory for all female patients within 30 days prior to registration in the trial. All patients must use an adequate method of contraception if the risk of conception exists.
? Written informed consent before registration according to ICH/EU GCP, and national/local regulations
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

? 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Investigate the activity and safety of the combination of bortezomib and cisplatin as first line treatment for malignant mesothelioma.;<br> Secondary Objective: - Validate the use of the progression free survival rate (PFSR) as primary end point for the design of mesothelioma phase II trials.<br> - 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<br> ;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.

Secondary Outcome Measures

Name	Time	Method

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