Phase I/II study with cisplatin and pemetrexed +/- sorafenib in malignant pleural mesothelioma (SoMe study) - SoMe Study

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI0 sitesJanuary 15, 2008

Overview

No summary available.

Registry

who.int

Start Date

January 15, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

•1\.Histologically proven diagnosis of malignant mesothelioma in patients not candidates for curative surgery. Patients will be clinically staged using the international Mesothelioma Interest Group Tumor Nodes Metastasis (IMIG TNM) staging criteria. (see protocol attachment 11\.1\.3\)
•2\.Subjects with at least one uni\-dimensional (for RECIST modified) measurable lesion. Lesions must be measured by CT\-scan or MRI (see protocol attachment 11\.1\.6\)
•3\.Age \> 18 years.
•4\.ECOG Performance Status of 0 or1(see protocol attachment 11\.1\.4\)
•5\.Life expectancy of at least 12 weeks.
•6\.Patients must sign an informed consent document before the start of specific protocol procedures
•7\.No previous chemotherapy for advanced disease
•8\.Patients may have undergone pleurodesis. If pleurodesis was performed, a minimum of 2 week delay before starting study treatment is suggested to permit resolution of an acute inflammatory reaction.
•9\.Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
•Hemoglobin \> 9\.0 g/dl

•Patients will be excluded from the study if they meet any of the following criteria:
•Excluded medical conditions:
•1\.Hystory of cardiac disease:congestive heart failure \>NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrythmias requiering anti\-arrythmic therapy( beta blockers or digoxin are permitted) or uncontrolled hypertension.
•2\.Active clinically serious infections (\> grade 2 NCI\-CTC version 3\.0\)
•3\.Symptomatic metastatic brain or meningeal tumors (unless the patient is \> 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry)
•4\.Patients with seizure disorder requiring medication (such as steroids or anti\-epileptics)
•5\.History of organ allograft The organ allograft may be allowed as protocol specific.
•6\.Patients with evidence or history of bleeding diasthesis
•7\.Patients undergoing renal dialisis
•8\.Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors \[Ta, Tis \& T1] or any cancer curatively treated \> 5 years prior to study entry.