ACTRN12610000915055已完成2 期
The effect of Carboplatin and Bevacizumab on progression free survival in recurrent Glioblastoma Multiforme: A randomised phase II study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •For inclusion in this study, all of the following inclusion criteria must be fulfilled: 1. Patients with glioblastoma multiforme (GBM) with a tissue diagnosis that has been established following either a surgical resection or biopsy, and who have had prior treatment with both radiotherapy and temozolomide (concurrently and/or sequentially); 2. Recurrent/progressive disease confirmed by surgical resection or MRI (measurable disease according to RANO criteria). Measurable disease will be characterised by all of the following: at least one site of bi-dimensionally measurable disease, two perpendicular diameters of at least 10mm, visible on 2 or more axial slices that are preferably, at most, 5mm thick with 0-mm skip (or at least two times the slice thickness if the MRI is performed with thicker slices), must be measured using contrast enhanced MRI, MRI showing progression must be performed within 14 days before randomisation and at least 12 weeks post cessation of radiotherapy or stereotactic radiosurgery. The MRI must be compared with a prior MRI performed post-radiotherapy; 3. Craniotomy or intracranial biopsy site must be adequately healed; free of drainage or cellulitis, and the underlying cranioplasty must appear intact at the time of randomisation. Study treatment should be initiated greater than or equal to 28 days following the last surgical procedure (including biopsy, surgical resection, wound revision, or any other major surgery involving entry into a body cavity); 4. WHO/Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2; 5. At least 12 weeks must have elapsed since the cessation of radiotherapy or stereotactic radiosurgery; 6. Adequate renal function (within 2 weeks prior to randomisation): creatinine less than or equal to 1.25x ULN or creatinine clearance rate greater than or equal to 60ml/min AND urine dipstick for proteinuria less than 2+ OR urine protein/creatinine ratio (UPC) less than or equal to 1.0. Patients discovered to have greater than or equal to 2+ proteinuria on dipstick urinalysis at screening should undergo a urine protein/creatinine ratio (or 24 hour urine collection if preferred) and must demonstrate less than or equal to 1.0g of protein in 24 hours; 7. Laboratory values (within 2 weeks prior to randomisation): absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L, Leucocyte count greater than 3.0 x 109/L, Platelets greater than or equal to 100 x 109/L, Haemoglobin greater than or equal to 100 g/L, Total bilirubin less than or equal to 1.5 x ULN, AST, ALT and ALP less than or equal to 2.5 x ULN (less than or equal to 5 x ULN when attributable to anticonvulsants); 8. International normalized ratio (INR) or prothrombin time (PT) (secs) and activated partial thromboplastin time (aPTT) less than or equal to 1.5 x ULN (except for subjects receiving anticoagulation therapy at the time of screening) in the absence of therapeutic intent to anticoagulate the subject, OR within therapeutic limits (according to the medical standard in the institution) in the presence of therapeutic intent to anticoagulate the subject at the time of screening.
- •NOTE: As per American Society of Clinical Oncology (ASCO) guidelines, low molecular weight heparin (LMWH) is the preferred approach; 9. Signed informed consent.
排除标准
- •Patients are not eligible for this study if they fulfil one or more of the following exclusion criteria: 1. Prior therapy with bevacizumab or any other VEGF/VEGFR inhibitor or EGFR inhibitor; 2. Prior chemotherapy (other than temozolomide) or investigational agent for the treatment of glioma; 3. Investigational agent (for reason other than treatment of GBM) within 28 days prior to randomisation or at any time during the study; 4. Chemotherapy (i.e. temozolomide) within 21 days prior to randomisation (with the exception of dose dense/continuous low dose ‘metronomic’ temozolomide in which chemotherapy must cease greater than or equal to 7 days prior to randomisation); 5. Treatment with biologic agent/s within 28 days prior to randomisation; 6.Known hypersensitivity to any excipients of bevacizumab formulation or to carboplatin; 7. Hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanised antibody; 8. Have had any surgery, open biopsy, intracranial biopsy, ventriculoperitoneal shunt or significant traumatic injury within 4 weeks prior to start of treatment on this study or who have not recovered from side effects of such therapy;
- •9. Core biopsy (excluding intracranial biopsy) within 7 days prior to randomisation, or other minor surgical procedure including placement of a central venous access device (CVAD) within 2 days prior to bevacizumab administration; 10. Pregnancy or lactation; 11. Patient (male or female) is not willing to use highly effective methods of contraception (e.g. double barrier method) during treatment and for 6 months (male or female) after the end of treatment; 12. Evidence of recent haemorrhage on MRI of the brain. However patients with clinically asymptomatic presence of haemosiderin, resolving haemorrhagic changes related to surgery, and presence of punctate haemorrhage in the tumour are permitted entry into the study; 13. Calculated creatinine clearance (Cockroft-Gault) less than 60ml/min; 14. Inability to undergo MRI (e.g. has a pacemaker); 15. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse; 16. Any of the following conditions: a) Inadequately controlled hypertension (defined as systolic blood pressure greater than150 mmHg and/or diastolic blood pressure greater than 100 mm Hg); or prior history of hypertensive crisis or hypertensive encephalopathy, b) New York Heart Association (NYHA) Grade II or greater congestive heart failure, c) History of myocardial infarction, unstable angina, stroke or transient ischaemic attack (TIA), or significant vascular disease (e.g. aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to randomisation,
- •d) History of greater than or equal to grade 2 haemoptysis according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 criteria within 1 month prior to randomisation, e) History of abdominal fistula, gastrointestinal perforation, or intracranial abscess within 6 months prior to randomisation, f) History of coagulation disorder associated with bleeding or recurrent thrombotic events, g)Prior or co-existent malignancy except non-melanomatous skin cancer, or malignancy treated and disease free for greater than 5 years, h) Concurrent illness, including serious non-healing wound, active u
研究者
相似试验
终止
1 期
Carboplatin, Bevacizumab and Pemetrexed in the First-Line Treatment of Patients With Malignant Pleural Mesothelioma (MPM)MesotheliomaNCT00604461H. Lee Moffitt Cancer Center and Research Institute13
已完成
2 期
Bevacizumab and Carboplatin/Paclitaxel and Radiation in Non-Small Cell Lung CancerNon-Small Cell Lung CancerNCT00578149Dana-Farber Cancer Institute45
已完成
2 期
Carboplatin and Bevacizumab for Progressive Breast Cancer Brain MetastasesProgressive Breast CancerBreast CancerMetastatic Breast CancerNCT01004172Dana-Farber Cancer Institute38
已完成
2 期
Bevacizumab and Carboplatin for Patients With Ovarian CancerOvarian CancerNCT00744718Vejle Hospital73
已完成
2 期
Phase2 study of Carboplatin / Paclitaxel + Bevacizumab to non-small-cell lung cancer (non-squamous cell carcinoma) with pleural efussion in stage4non-small-cell lung cancer (non-squamous cell carcinoma) with pleural efussion in stage4JPRN-UMIN000005284Osaka Prefectural Medical Center for Respiratory and Allergic diseases20