A randomized phase I/II study of standard chemotherapy (cisplatin and pemetrexed) with or without Axitinib in patients with malignant mesothelioma: interim biopsy analysis and Dynamic Contrast Enhanced MRI to determine efficacy. - Axitinib in malignant mesothelioma

Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 26 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•Patients with histologically or cytologically diagnosed malignant mesothelioma and age >18 years.
•Medically suitable for limited surgical intervention (pleural biopsies or limited pleurectomy).
•Not considered candidates for trimodality treatment (as part of a study).
•Measurable or evaluable disease is not required (see tumor response assessment).
•Ability to understand the study and give signed informed consent prior to beginning of protocol specific procedures including the approval to accept a second thoracoscopic or surgical treatment after the third course.
•No previous chemotherapy.
•Radiotherapy is allowed when this is given for palliation, the interval is > 4 weeks, not more than 1/3 of the bone marrow capacity or all tumor is within the irradiation field.
•WHO performance status =<2
•Adequate organ function as evidenced by the following peripheral blood counts of serum chemistries at study entry:
•Hematology: Neutrophil count => 1.5 x 109/l, Platelets => 150 x 109/l, Hemoglobin => 6,0 mmol/l.
•Chemistry: Total serum bilirubin within the upper normal limits; ASAT (SGOT) and ALAT (SGPT) =< 2.5 times the upper normal limits, AP (alkaline phosphatases) < 5x UNL (unless bone metastases are present in the absence or any liver disease).

•Active uncontrolled infection, severe cardiac dysfunction or uncorrectable bleeding tendency.
•Previous successful pleurodesis.
•Uncontrolled hypertension.
•Symptomatic peripheral neuropathy > grade 2 according to NCIC Common Toxicity Criteria, version 3.0.
•Presence of symptomatic CNS metastases.
•Unstable peptic ulcer, unstable diabetes mellitus or other serious disabling condition.
•Concomitant administration to any other experimental drugs under investigation.
•Creatinine clearence < 60 ml/min

发起方

Antoni van Leeuwenhoek Ziekenhuis