EUCTR2006-004429-27-IT进行中（未招募）不适用
Phase II study of the combination of bevacizumab plus pemetrexed and carboplatin as first-line therapy in patients with malignant pleural mesothelioma - ND
ISTITUTO CLINICO HUMANITAS0 个研究点开始时间: 2007年10月15日最近更新:
适应症
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
- •INCLUSION CRITERIA 1. Histologically proven diagnosis of malignant pleural mesothelioma. 2. Inoperable disease according to local surgeon, not previously treated with chemotherapy; patients relapsed/progressed after previous surgery will be also evaluable for inclusion. 3. Age 18. 4. ECOG Performance Status 0-1 & life expectancy of at least 12 weeks. 5. Measurable and/or evaluable lesions according to RECIST criteria. 6. Laboratory requirements: Neutrophils 1.5 x 109/L and Platelets 100 x 109/L Total bilirubin 1.5 time the upper-normal limits (UNL) of the Institutional normal values, AST (SGOT) and ALT (SGPT) 2.5 x UNL, or 5 x UNL in case of liver metastases, alkaline phosphatase 2.5 x UNL, 5 x UNL in case of liver metastases, 10 x UNL in case of bone metastases. Creatinine clearance >50 mL/min, calculated according to the Cockroft and Gault formula. Urine dipstick of proteinuria <2+. Patients discovered to have 2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate 1 g of protein/24 hr. 7. Written informed consent. 8. Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating center.
- •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
- •1. Any prior chemotherapy for malignant pleural mesothelioma including intracavitary administration. 2. Symptomatic and/or unstable pre-existing brain metastases. 3. Serious non-healing wound or ulcer. 4. Evidence of bleeding diathesis or coagulopathy. 5. Uncontrolled hypertension. 6. Clinically significant (i.e. active) cardiovascular disease, for example cerebrovascular accidents (6 months), myocardial infarction ( 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication. 7. Current or recent (within 10 days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes. 8. Chronic, daily treatment with high-dose aspirin (>325 mg/day) or other medications known to predispose to gastrointestinal ulceration. 9. Treatment with any investigational drug within 30 days prior to enrolment. 10. Patients with known allergy to Chinese hamster ovary cell proteins, or any of the components of the study medications. 11. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ 12. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study. 13. Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study
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