Personalized treatment for patients with pleural effusions
- Conditions
- Proven pleural effusion of malignant pleural mesothelioma or non small cell lung cancerMedDRA version: 17.0Level: LLTClassification code 10066490Term: Progression of non-small cell lung cancerSystem Organ Class: 100000004864MedDRA version: 17.0Level: LLTClassification code 10027408Term: Mesothelioma malignant advancedSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-005621-24-NL
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
• Patients with histologically or cytologically proven pleural effusion of
malignant mesothelioma or non small cell lung cancer
• Age >18 years.
• At the date of randomization, the patients must have completed:
For MPM: first-line chemotherapy with platinum (cisplatin or carboplatin) and pemetrexed combination with evidence of progressive disease.
For NSCLC: first and second line therapy according to the local guide lines with evidence of progressive disease.
• Measurable or evaluable disease.
• Ability to understand the study and give signed informed consent prior to beginning of protocol specific procedures.
• WHO performance status = 2
• Adequate organ function as evidenced by the following peripheral blood counts or serum chemistries at study entry:
o Hematology: Neutrophil count = 1.5 x 109/l, Platelets = 100 x 109/l, Hemoglobin = 5.9 mmol/l.
o Hepatic function as defined by serum bilirubin = 1.25 times the upper limit of normal (ULN), ALT and AST = 2.5 times the ULN, except for liver metastases then ALAT and ASAT < 5 times the ULN.
o Renal function as defined by serum creatinine = 1.25 times ULN or creatinine clearance = 50 ml/min (by Cockcroft-Gault formula).
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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
• Active uncontrolled infection, severe cardiac dysfunction or non-correctable bleeding tendency.
• Any identification of a driver mutation for which a registered treatment is available
• Presence of symptomatic CNS metastases.
• Radiotherapy within 2 weeks prior to study entry.
• Unstable peptic ulcer, unstable diabetes mellitus or other serious disabling condition.
• Concomitant administration of any other experimental drugs under investigation.
• Any non-resolved grade 3 or higher toxicity.
• For neurotoxicity any non-resolved grade 2 or higher toxicity
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The aim of this study is to evaluate the efficacy of a personalized drug profiling method using short-term cultures of malignant cells derived from the patien's pleural fluid.;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint is accuracy of the drug profiling method, defined by the number of truly predicted responses, as a percentage of the total number of patients in the study. ;Timepoint(s) of evaluation of this end point: 12 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary objectives include objective response rate (ORR), progression free survival (PFS), overall survival (OS), pulmonary function, toxicity. <br>Exploratory endpoints to identify potential biomarkers include genomic profiling, assessment of breath prints of Volatile Organic Compounds by E-nose. ;Timepoint(s) of evaluation of this end point: PFS: 6 weekly<br>OS: 12 weekly<br>Pulmonary function (including E-nose): 6 and 12 weeks<br>Toxicity: 3 weekly