Proven pleural effusion of malignant pleural mesothelioma or non small cell lung cancer MedDRA version: 17.0 Level: LLT Classification code 10066490 Term: Progression of non-small cell lung cancer System Organ Class: 100000004864 MedDRA version: 17.0 Level: LLT Classification code 10027408 Term: Mesothelioma malignant advanced System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Gemcitabine
Product Name: Gemcitabine
Product Code: L01BC05
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: GEMCITABINE
CAS Number: 95058-81-4
Concentration unit
Sponsors
Stichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary objectives include objective response rate (ORR), progression free survival (PFS), overall survival (OS), pulmonary function, toxicity. 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 OS: 12 weekly Pulmonary function (including E-nose): 6 and 12 weeks Toxicity: 3 weekly | — |
Countries
Netherlands
Contacts
Public ContactJ.M.M.F. Quispel-Janssen
Stichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis
Outcome results
None listed