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)

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Stichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis

暂无简介。

•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

发起方