malignant mesothelioma
Conditions
Interventions
Standard treatment of cisplatin (75 mg/m2) combined with pemetrexed (500 mg/m2)
for 3-4 courses compared with the addition of axitinib oral treatment
Patients will be asked to allow a second thorac
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: •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 = 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) =
Exclusion criteria
Exclusion criteria: •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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective: (1) To determine the effects of the addition of axitinib to standard chemotherapy on tissue samples with respect to micro-vessel density (MVD); expression of VEGF-Receptor; PDGF receptor expression; extent of necrosis and apoptosis. (2) To determine the safety of the addition of axitinib (to a maximum of the recommended dose of maximally 2 x 5 mg per day) to the standard treatment with cisplatin and pemetrexed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objective(s): (3) To determine the feasibility of performing a (second) thoracoscopy after 10 weeks of the combination treatment with cisplatin, pemetrexed and axitinib. (4) Serum samples will be collected and tested for inhibiting effects in a tube formation and spheroid sprouting assay. | — |
Countries
Netherlands
Outcome results
None listed