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) - Personalized treatment for patients with pleural effusions

Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 80 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•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).

•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

发起方

Antoni van Leeuwenhoek Ziekenhuis