EUCTR2007-005894-77-IT进行中（未招募）不适用
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 个研究点开始时间: 2008年1月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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]
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