PeRsOnalized treatment fOr patients with pleural eFfusions due to malignant pleural mesothelioma or lung cancer in second or third line. An open label phase II study (Acronym: the PROOF study)

Phase 2

Conditions: mesothelioma and lungcancer
10038666

Registration Number: NL-OMON40679

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

• Patients with histologically or cytologically proven malignant mesothelioma or non small cell lung cancer that have a pleural effusion;
• Age > 18 years;
• At the time of pleural fluid drainage, patients must have completed:
For MPM: at least first-line chemotherapy with a platinum (cisplatin or carboplatin) and pemetrexed combination.
For NSCLC: at least first and second line therapy according to the local guidelines.
• At the start of study treatment, patients must have documented 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), ALAT and ASAT <= 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).

Exclusion Criteria

• 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 start of study treatment.
• 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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is accuracy of the drug profiling method, defined by the<br /><br>number of truly predicted responses, as a percentage of the total number of<br /><br>patients in the study. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include objective response rate (ORR), progression free<br /><br>survival (PFS), overall survival (OS), pulmonary function and frequency and<br /><br>severity of adverse events. Exploratory endpoints to identify potential<br /><br>biomarkers include genomic profiling, assessment of breath prints of Volatile<br /><br>Organic Compounds by E-nose. </p><br>