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

• Conditions: malignant pleural mesothelioma (MPM); MedDRA version: 9.1Level: LLTClassification code 10059518Term: Pleural mesothelioma malignant

• Registration Number: EUCTR2007-005894-77-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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
Absolute neutrophil count (ANC) >1,500/mm3
Platelet count  100,000/μl
Total bilirubin < 1.5 times the upper limit of normal
ALT and AST < 2.5 x upper limit of normal (< 5 x upper limit of normal for patients with liver involvement of their cancer)
Alkaline phosphatase < 4 x ULN
Serum creatinine < 1.2 mg/dl
10.PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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.
9.Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however they may not be substituted for a required dose reduction.] [Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study]

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the efficacy and safety of sorafenib in combination with cisplatin plus pemetrexed in patients with pleural mesothelioma not previously treated with chemotherapy;Secondary Objective: Secondary end-points:<br>To determine the Overall survival (OS)<br>To determine the Response rate (RR)<br>To determine the Overall Duration of response<br>To determine the Time to progression,<br>To evaluate the Safety<br><br>Ancillary end-points:<br>To evaluate the Quality of life.;Primary end point(s): Primary end-point:<br>To determine the Progression free survival (PFS).